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Intervenciones para la promoción de la actividad física en pacientes con enfermedad pulmonar obstructiva crónica (EPOC)

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Referencias

Referencias de los estudios incluidos en esta revisión

Alison 2019 {published data only}

Alison JA, McKeough ZJ, Jenkins SC, Holland AE, Hill K, Morris NR, et al. A randomised controlled trial of supplemental oxygen versus medical air during exercise training in people with chronic obstructive pulmonary disease: supplemental oxygen in pulmonary rehabilitation trial (SuppORT) [protocol]. BMC Pulmonary Medicine 2016;1:25. CENTRAL
Alison JA, McKeough ZJ, Leung RW, Holland AE, Hill K, Morris NR, et al. Oxygen compared to air during exercise training in COPD with exercise‐induced desaturation. European Respiratory Journal 2019;53:1802429. CENTRAL

Altenburg 2015 {published data only}

Altenburg W, Wempe J, De Greef M, Ten Hacken N, Kerstjens H. Short‐ and long‐term effects of a physical activity counselling program in COPD [abstract]. European Respiratory Journal 2014;44:3490. CENTRAL
Altenburg WA, Ten Hacken NH, Bossenbroek L, Kerstjens HA, De Greef MH, Wempe JB. Short‐ and long‐term effects of a physical activity counselling programme in COPD: a randomized controlled trial. Respiratory Medicine 2015;109(1):112‐21. CENTRAL

Arbillaga‐Etxarri 2018 {published data only}

Arbillaga‐Etxarri A, Gimeno‐Santos E, Balcells E, Barberan‐Garcia A, Benet M, Celorrio N, et al. Effectiveness of an intervention of urban training in patients with COPD: a randomized controlled trial [abstract]. European Respiratory Journal 2017;50:OA513. CENTRAL
Arbillaga‐Etxarri A, Gimeno‐Santos E, Barberan‐Garcia A, Balcells E, Benet M, Borrell E, et al. Long‐term efficacy and effectiveness of a behavioural and community‐based exercise intervention (Urban Training™) to increase physical activity in patients with COPD. A randomised controlled trial. European Respiratory Journal 2018;52(4):1800063. CENTRAL
Arbillaga‐Etxarri A, Torrent‐Pallicer J, Gimeno‐Santos E, Barberan‐Garcia A, Delgado A, Balcells E, et al. Validation of walking trails for the urban training of chronic obstructive disease patients. PLoS ONE 2016;11(1):e0146705. CENTRAL

Beeh 2014 {published and unpublished data}

Beeh KM, Watz H, Puente‐Maestu L, De Teresa L, Jarreta D, Caracta C, et al. Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo‐controlled, crossover trial. BMC Pulmonary Medicine 2014;14(1):209. CENTRAL

Bender 2016 {published data only}

Bender BG, Depew A, Emmett A, Goelz K, Make B, Sharma S, et al. A patient‐centered walking program for COPD. Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation 2016;3(4):769‐77. CENTRAL
Bender BG, Make BJ, Emmett A, Sharma S, Stempel D. Enhancing physical activity in patients with chronic obstructive pulmonary disease (COPD) through a program of patient selected goals [abstract]. American Journal of Respiratory and Critical Care Medicine 2015;191:A2458. CENTRAL

Benzo 2016 {published data only (unpublished sought but not used)}

Benzo R, McEvoy C. Effect of health coaching delivered by a respiratory therapist or nurse on self‐management abilities in severe COPD: analysis of a large randomized study. Respiratory Care 2019;64(9):1065‐72. CENTRAL
Benzo R, Vickers K, Ernst D, Tucker S, McEvoy C, Lorig K. Development and feasibility of a self‐management intervention for chronic obstructive pulmonary disease delivered with motivational interviewing strategies. Journal of Cardiopulmonary Rehabilitation and Prevention 2013;33(2):113‐22. CENTRAL
Benzo R, Vickers K, Novotny PJ, Tucker S, Hoult J, Neuenfeldt P, et al. Health coaching and chronic obstructive pulmonary disease rehospitalization: a randomized study. American Journal of Respiratory and Critical Care Medicine 2016;194(6):672‐80. CENTRAL

Blumenthal 2014 {published data only}

Blumenthal JA, Emery CF, Smith PJ, Keefe FJ, Welty‐Wolf K, Mabe S, et al. The effects of a telehealth coping skills intervention on outcomes in chronic obstructive pulmonary disease: primary results from the INSPIRE‐II study. Psychosomatic Medicine 2014;76(8):581‐92. CENTRAL
Blumenthal JA, Keefe FJ, Babyak MA, Fenwick CV, Johnson JM, Stott K, et al. Caregiver‐assisted coping skills training for patients with COPD: background, design, and methodological issues for the INSPIREII study. Clinical Trials 2009;6(2):172‐84. CENTRAL

Borges 2014 {published and unpublished data}

Borges R, Carvalho CR. Effect of resistance training during hospitalization in the systemic inflammation, functional capacity and muscle strength in COPD patients [abstract]. European Respiratory Journal 2011;38:1890. CENTRAL
Borges RC, Carvalho CR. Impact of resistance training in chronic obstructive pulmonary disease patients during periods of acute exacerbation. Archives of Physical Medicine and Rehabilitation 2014;95(9):1638‐45. CENTRAL

Breyer 2010 {published data only (unpublished sought but not used)}

Breyer MK, Breyer‐Kohansal R, Funk GC, Dornhofer N, Spruit MA, Wouters EF, et al. Nordic walking improves daily physical activities in COPD: a randomised controlled trial. Respiratory Research 2010;11:112. CENTRAL
Breyer MK, Kohansal R, Burghuber OC, Hartl S. The effects of Nordic walking on exercise capacity and physical activity in daily life (AoDL) in COPD [abstract]. European Respiratory Journal 2008;32(Supp 52):1754. CENTRAL

Burtin 2015 {published data only}

Burtin C, Lander D, Van Remoortel H, Gosselinki R, Decramer M, Janssens W, et al. Physical activity counseling and long‐term effects of pulmonary rehabilitation [abstract]. American Journal of Respiratory and Critical Care Medicine 2012;185:A3675. CENTRAL
Burtin C, Langer D, Van Remoortel H, Demeyer H, Gosselink R, Decramer M, et al. Physical activity counselling during pulmonary rehabilitation in patients with COPD: a randomised controlled trial. PLOS One 2015;10(12):e0144989. CENTRAL
Burtin C, Langer D, Van Remoortel J, Demeyer H, Gosselink R, Decramer M, et al. Correction: Physical activity counselling during pulmonary rehabilitation in patients with COPD: a randomised controlled trial. PLOS One 2016;11(2):e0148705. CENTRAL

Casaburi 2012 {published data only}

Casaburi R, Porszasz J, Hecht A, Tiep B, Albert RK, Anthonisen NR, et al: for the COPD Clinical Research Network. Influence of lightweight ambulatory oxygen on oxygen use and activity patterns of COPD patients receiving long‐term oxygen therapy. Journal of Chronic Obstructive Pulmonary Disease 2012;9(1):3‐11. CENTRAL

Chaplin 2017 {published data only}

Barnes A, Newby C, Chaplin E, Houchen‐Wolloff, Singh SJ. Purposeful physical activity in COPD patients comparing standard and web based pulmonary rehabilitation [abstract]. European Respiratory Journal 2016;48(Supp 60):PA2056. CENTRAL
Chaplin E, Hewitt S, Apps L, Bankart J, Pulikottil‐Jacob R, Boyce S, et al. Interactive web‐based pulmonary rehabilitation programme: a randomised controlled feasibility trial. BMJ Open 2017;7(3):e013682. CENTRAL
Chaplin E, Hewitt S, Apps L, Edwards K, Brough C, Glab A, et al. An interactive web‐based programme: a randomised controlled feasibility trial [abstract]. European Respiratory Journal 2016;48(Suppl 60):PA2064. CENTRAL
Chaplin E, Hewitt S, Apps L, Edwards K, Brough C, Glab A, et al. The evaluation of an interactive web‐based pulmonary rehabilitation programme: protocol for the WEB SPACE for COPD feasibility study. BMJ Open 2015;5(8):e008055. CENTRAL

Charususin 2018 {published data only}

Charususin N, Gosselink R, Decramer M, Demeyer H, McConnell A, Saey D, et al. Randomised controlled trial of adjunctive inspiratory muscle training for patients with COPD. Thorax 2018;73(10):942‐50. CENTRAL
Charususin N, Gosselink R, Decramer M, McConnell A, Saey D, Maltais F, et al. Inspiratory muscle training protocol for patients with chronic obstructive pulmonary disease (IMTCO study): A multicentre randomised controlled trial. BMJ Open 2013;3(8):e003101. CENTRAL

Cruz 2016 {published data only}

Cruz J, Brooks D, Marques A. Walk2Bactive: a randomised controlled trial of a physical activity‐focused behavioural intervention beyond pulmonary rehabilitation in chronic obstructive pulmonary disease. Chronic Respiratory Disease 2016;13(1):57‐66. CENTRAL

Curtis 2016 {published data only}

Curtis KJ, Meyrick VM, Mehta B, Haji GS, Li K, Montgomery H, et al. Angiotensin‐converting enzyme inhibition as an adjunct to pulmonary rehabilitation in chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2016;194(11):1349‐57. CENTRAL

Dal Negro 2012 {published data only (unpublished sought but not used)}

Dal Negro RW, Aquilani R, Bertacco S, Boschi F, Micheletto C, Tognella S. Comprehensive effects of supplemented essential amino acids in patients with severe COPD and sarcopenia. Monaldi Archives of Chest Disease 2010;73(1):25‐33. CENTRAL
Dal Negro RW, Testa A, Aquilani R, Tognella S, Pasini E, Barbieri A, et al. Essential amino acid supplementation in patients with severe COPD: a step towards home rehabilitation. Monaldi Archives of Chest Disease 2012;77(2):67‐75. CENTRAL

De Blok 2006 {published data only}

De Blok BM, De Greef MH, Ten Hacken NH, Sprenger SR, Postema K, Wempe JB. The effects of a lifestyle physical activity counseling program with feedback of a pedometer during pulmonary rehabilitation in patients with COPD a pilot study [abstract]. European Respiratory Journal 2005;26(Suppl 49):548. CENTRAL
De Blok BM, De Greef MH, Ten Hacken NH, Sprenger SR, Postema K, Wempe JB. The effects of a lifestyle physical activity counseling program with feedback of a pedometer during pulmonary rehabilitation in patients with COPD: a pilot study. Patient Education and Counseling 2006;61(1):48‐55. CENTRAL

Demeyer 2017 {published and unpublished data}

Demeyer H, Louvaris Z, Frei A, Rabinovich RA, De Jong C, Gimeno‐Santos E, et al: on behalf of the Mr Papp PROactive study group and the PROactive consortium. Physical activity is increased by a 12‐week semiautomated telecoaching programme in patients with COPD: a multicentre randomised controlled trial. Thorax 2017;72(5):415‐23. CENTRAL
Demeyer H, Louvaris Z, Tanner R, Rubio N, Frei A, De Jong C, et al. Increasing physical activity in patients with COPD using a telecoaching program: a multicentre RCT [abstract]. European Respiratory Journal 2015;46:OA278. CENTRAL
Loeckx M, Louvaris Z, Tanner R, Rubio N, Frej A, De Jong C, et al. Contact time between patients with COPD and coach during an activity telecoaching intervention: Impact on the intervention effect [abstract]. European Respiratory Journal 2016;48(Suppl 60):OA4817. CENTRAL
Loeckx M, Louvaris Z, Tanner RJ, Yerramasu C, Busching G, Frei A, et al. Compliance with a three month telecoaching program to enhance physical activity in patients with Chronic Obstructive Pulmonary Disease [abstract]. American Journal of Respiratory and Critical Care Medicine 2015;191:A2007. CENTRAL
Loeckx M, Rabinovich RA, Demeyer H, Louvaris Z, Tanner R, Rubio N, et al. Smartphone‐based physical activity telecoaching in chronic obstructive pulmonary disease: mixed‐methods study on patient experiences and lessons for implementation. JMIR mHealth and uHealth 2018;6(2):e200. CENTRAL

De Roos 2017 {published and unpublished data}

De Roos P, Lucas C, Strijbos JH, Van Trijffel E. Effectiveness of a combined exercise training and home‐based walking programme on physical activity compared with standard medical care in moderate COPD: a randomised controlled trial. Physiotherapy 2017;104(1):116‐21. CENTRAL

Duiverman 2008 {published data only}

Duiverman ML, Bladder G, Wempe JB, Kerstjens HA, Zijlstra JG, Wijkstra PJ. Chronic ventilatory support improves the outcomes of rehabilitation in hypercapnic COPD patients [abstract]. American Thoracic Society International Conference; 2008 May 16‐21; Toronto. 2008:A557. CENTRAL
Duiverman ML, Wempe JB, Bladder G, Jansen DF, Kerstjens HA, Zijlstra JG, et al. Nocturnal non‐invasive ventilation in addition to rehabilitation in hypercapnic patients with COPD. Thorax 2008;63(12):1052‐7. CENTRAL

Effing 2011 {published data only}

Effing T, Zielhuis G, Kerstjens H, Van der Valk P, Van der Palen J. Community based physiotherapeutic exercise in COPD self‐management: a randomised controlled trial. Respiratory Medicine 2011;105(3):418‐26. CENTRAL
Zwerink M, Effing T, Kerstjens HA, Van der Valk P, Brusse‐Keizer M, Zielhuis G, et al. Cost‐effectiveness of a community‐based exercise programme in COPD self‐management. Journal of Chronic Obstructive Pulmonary Disease 2016;13(2):214‐23. CENTRAL
Zwerink M, Van der Palen J, Kerstjens HA, Van der Valk P, Brusse‐Keizer M, Zielhuis G, et al. A community‐based exercise programme in COPD self‐management: two years follow‐up of the COPD‐II study. Respiratory Medicine 2014;108(10):1481‐90. CENTRAL
Zwerink M, Van der Palen J, Kerstjens HA, Van der Valk P, Brusse‐Keizer M, Zielhuis G, et al. A community‐based exercise programme in COPD self‐management: two‐year follow‐up of the COPD‐II study [abstract]. European Respiratory Journal 2014;44:1711. CENTRAL
Zwerink M, Van der Palen J, Van der Valk P, Brusse‐Keizer M, Effing T. Relationship between daily physical activity and exercise capacity in patients with COPD. Respiratory Medicine 2013;102(2):242‐8. CENTRAL

Egan 2010 {published and unpublished data}

Egan C, Costello R, Deering B, McCormack NM, Blake C. Physical activity in COPD patients following pulmonary rehabilitation [abstract]. European Respiratory Society 20th Annual Congress; 2010 Sep 18‐22; Barcelona. 2010:E3535. CENTRAL
Egan C, Deering BM, Blake C, Fullen BM, McCormack NM, Spruit MA, et al. Short term and long term effects of pulmonary rehabilitation on physical activity in COPD. Respiratory Medicine 2012;106(12):1671‐9. CENTRAL

Felcar 2018 {published data only}

Felcar JM, Probst VS, De Carvalho DR, Merli MF, Mesquita R, Vidotto LS, et al. Effects of exercise training in water and on land in patients with COPD: a randomised clinical trial. Physiotherapy 2018;104(4):408‐16. CENTRAL
Felcar JM, Probst VS, De Carvalho DR, Merli MF, Mesquita RB, Vidotto LS, et al. Effects of exercise training in water and on land in patients with COPD [abstract]. European Respiratory Journal 2015;46(Suppl 59):PA2396. CENTRAL

Gamper 2019 {published data only}

Gamper E, Schmidt U, Bansi J, Kool J. Outdoor walking training compared to cycle ergometer training in severe COPD: a randomized controlled feasibility trial. COPD: Journal of Chronic Obstructive Pulmonary Disease 2019;16(1):37‐44. CENTRAL

Goris 2003 {published data only}

Goris AH, Vermeeren MA, Wouters EF, Schols AM, Westerterp KR. Energy balance in depleted ambulatory patients with chronic obstructive pulmonary disease: the effect of physical activity and oral nutritional supplementation. British Journal of Nutrition 2003;89(5):725‐9. CENTRAL

Hartman 2016 {published data only}

Hartman JE, Klooster K, Slebos DJ, Ten Hacken NH. Daily physical activity significantly improves after endobronchial valve treatment in patients with emphysema [abstract]. European Respiratory Journal 2015;46:OA1767. CENTRAL
Hartman JE, Klooster K, Slebos DJ, ten Hacken NH. Improvement of physical activity after endobronchial valve treatment in emphysema patients. Respiratory Medicine 2016;117:116‐21. CENTRAL

Holland 2017 {published data only}

Holland AE, Mahal A, Hill CJ, Lee AL, Burge AT, Cox NS, et al. Home‐based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial. Thorax 2017;72(1):57‐65. CENTRAL
Holland AE, Mahal A, Hill CJ, Lee AL, Burge AT, Cox NS, et al. Low cost home‐based pulmonary rehabilitation for chronic obstructive pulmonary disease: a randomized controlled equivalence trial [abstract]. American Journal of Respiratory and Critical Care Medicine 2016;193:A2620. CENTRAL
Holland AE, Mahal A, Hill CJ, Lee AL, Burge AT, Moore R, et al. Benefits and costs of home‐based pulmonary rehabilitation in chronic obstructive pulmonary disease ‐ a multi‐centre randomised controlled equivalence trial [protocol]. BMC Pulmonary Medicine 2013;13:57. CENTRAL
Lahham A, McDonald CF, Mahal A, Lee AL, Hill CJ, Burge AT, et al. Participation in physical activity during center and home‐based pulmonary rehabilitation for people with COPD: a secondary analysis of a randomized controlled trial. Journal of Cardiopulmonary Rehabilitation and Prevention 2019;39:E1‐4. CENTRAL
Liacos A, McDonald CF, Mahal A, Hill CJ, Lee AL, Burge AT, et al. The Pulmonary Rehabilitation Adapted Index of Self‐Efficacy (PRAISE) tool predicts reduction in sedentary time following pulmonary rehabilitation in people with chronic obstructive pulmonary disease (COPD). Physiotherapy 2019;105(1):90‐7. CENTRAL

Hornikx 2015 {published data only}

Hornikx M, Demeyer H, Camillo CA, Janssens W, Troosters T. The effects of a physical activity counseling program after an exacerbation in patients with chronic obstructive pulmonary disease: a randomized controlled pilot study. BMC Pulmonary Medicine 2015;15:136. CENTRAL
Hornikx M, Demeyer H, Camillo CA, Janssens W, Troosters T. The effects of physical activity coaching in patients with COPD after an acute exacerbation [abstract]. European Respiratory Journal 2014;44:1920. CENTRAL

Hospes 2009 {published data only (unpublished sought but not used)}

Hospes G, Bossenbroek L, Ten Hacken NH, Van Hengel P, De Greef MH. Enhancement of daily physical activity increases physical fitness of outclinic COPD patients: results of an exercise counseling program. Patient Education and Counseling 2009;75(2):274‐8. CENTRAL
Hospes G, Ten Hacken NH, Van Hengel P, De Greef MH. Pedometer‐based exercise counseling in COPD [abstract]. American Thoracic Society International Conference; 2007 May 18‐23; San Francisco. 2007; Vol. 175:A601. CENTRAL

Jolly 2018 {published data only}

Jolly K, Sidhu MS, Hewitt CA, Coventry PA, Daley A, Jordan R, et al. Self management of patients with mild COPD in primary care: randomised controlled trial. BMJ 2018;361:k2241. CENTRAL
Sidhu MS, Daley A, Jordan R, Coventry PA, Heneghan C, Jowett S, et al. Patient self‐management in primary care patients with mild COPD – protocol of a randomised controlled trial of telephone health coaching. BMC Pulmonary Medicine 2015;15(1):16. CENTRAL

Kanabar 2015 {published and unpublished data}

Kanabar P, Warrington V, Houchen‐Wolloff L, Singh SJ. Investigating the profile of physical activity in COPD patients 7 days post discharge from a respiratory‐related admission. Does brief advice have an effect? [abstract]. Thorax 2015;70(Suppl 3):A146. CENTRAL

Kawagoshi 2015 {published data only}

Kawagoshi A, Kiyokawa N, Iwakura M, Okura K, Sugawara K, Takahashi H, Sakata S, Satake M, Shioya T. Effects of low‐intensity exercise and home‐based pulmonary rehabilitation with pedometer feedback on physical activity in elderly patients with COPD [abstract]. European Respiratory Journal 2015;46:PA3563. CENTRAL
Kawagoshi A, Kiyokawa N, Sugawara K, Takahashi H, Sakata S, Satake M, et al. Effects of low‐intensity exercise and home‐based pulmonary rehabilitation with pedometer feedback on physical activity in elderly patients with chronic obstructive pulmonary disease. Respiratory Medicine 2015;109(3):364‐71. CENTRAL

Larson 2014 {published data only (unpublished sought but not used)}

Covey MK, McAuley E, Kapella MC, Collins EG, Alex CG, Berbaum ML, et al. Upper‐body resistance training and self‐efficacy enhancement in COPD. Journal of Pulmonary and Respiratory Medicine 2012;Suppl 9:001. CENTRAL
Larson JL, Covey MK, Kapella MC, Alex CG, McAuley E. Self‐efficacy enhancing intervention increases light physical activity in people with chronic obstructive pulmonary disease. International Journal of Chronic Obstructive Pulmonary Disease 2014;9:1081‐90. CENTRAL

Loeckx 2018 {published data only}

Loeckx M, Rodrigues F, Demeyer H, Janssens W, Troosters T. Improving physical activity to obtain sustainable benefits in extra‐pulmonary consequences of COPD after pulmonary rehabilitation: a randomized controlled trial [abstract]. American Journal of Respiratory and Critical Care Medicine 2018;197:A2452. CENTRAL

Lord 2012 {published data only (unpublished sought but not used)}

Lord VM, Hume VJ, Kelly JL, Cave P, Silver J, Waldman M, et al. Effects of 'singing for breathing' in patients with chronic obstructive pulmonary disease (COPD) ‐ a randomized controlled trial [abstract]. American Journal of Respiratory and Critical Care Medicine 2012;185:A5788. CENTRAL
Lord VM, Hume VJ, Kelly JL, Cave P, Silver J, Waldman M, et al. Singing classes for chronic obstructive pulmonary disease: a randomized controlled trial. BMC Pulmonary Medicine 2012;12:69. CENTRAL

Louvaris 2016 {published and unpublished data}

Kortianou E, Louvaris Z, Spetsioti S, Vasilopoulou M, Chynkiamis N, Nasis I, et al. High‐intensity interval exercise training improves daily physical activity levels in COPD [abstract]. European Respiratory Journal 2014;44(Suppl 58):1709. CENTRAL
Louvaris Z, Spetsioti S, Kortianou EA, Vasilopoulou M, Nasis I, Kaltsakas G, et al. Aerobic interval training induces clinically meaningful effects in daily physical activity in COPD [abstract]. European Respiratory Journal 2016;48:PA2053. CENTRAL
Louvaris Z, Spetsioti S, Kortianou EA, Vasilopoulou M, Nasis I, Kaltsakas G, et al. Interval training induces clinically meaningful effects in daily activity levels in COPD. European Respiratory Journal 2016;48(2):567‐70. CENTRAL

Maddocks 2016 {published data only}

Maddocks M, Nolan CM, Man WD, Polkey MI, Hart N, Gao W, et al. Neuromuscular electrical stimulation to improve exercise capacity in patients with severe COPD: a randomised double‐blind, placebo‐controlled trial. Lancet Respiratory Medicine 2016;4(1):27‐36. CENTRAL

Magnussen 2017 {published and unpublished data}

Magnussen H, Arzt M, Andrea S, Plate T, Ribera A, Seoane B, et al. Aclidinium bromide improves symptoms and sleep quality in COPD: a pilot study. European Respiratory Journal 2017;49(6):1700485. CENTRAL
Magnussen H, Arzt M, Andreas S, Plate T, Ribera A, Seoane B, et al. The effect of aclidinium bromide 400µg on lung function, sleep quality and physical activity in patients with chronic obstructive pulmonary disease: results of a phase IV pilot study [abstract]. American Journal of Respiratory and Critical Care Medicine 2016;193:A6820. CENTRAL
Magnussen H, Arzt M, Andreas S, Plate T, Ribera A, Seoane B, et al. The effect of aclidinium bromide 400µg on sleep quality in COPD: a pilot study [abstract]. European Respiratory Journal 2016;48:PA4051. CENTRAL

Mantoani 2018 {published data only}

Mantoani L, McKinstry B, McNarry S, Mullen S, Begg S, Saini P, et al. Physical activity enhancing programme (PAEP) in COPD – a randomised controlled trial [abstract]. European Respiratory Journal 2018;52(Suppl 62):OA1986. CENTRAL

Mendoza 2015 {published data only}

Mendoza L, Aguilera M, Balmaceda N, Espinoza J, Horta P, Castro A, et al. Effect of a program of physical activity enhancement using pedometers in patients with chronic obstructive pulmonary disease [abstract]. American Journal of Respiratory and Critical Care Medicine 2013;187:A1360. CENTRAL
Mendoza L, Aguilera M, Espinoza J, Balmaceda N, Horta P, Castro A, et al. Effects of a program of physical activity encouragement using pedometers in COPD patients [abstract]. European Respiratory Journal 2013;45(2):A570. CENTRAL
Mendoza L, Horta P, Espinoza J, Aguilera M, Balmaceda N, Castro A, et al. Pedometers to enhance physical activity in COPD: a randomised controlled trial. European Respiratory Journal 2015;45(2):347‐54. CENTRAL

Mitchell 2013 {published and unpublished data}

Mitchell KE, Johnson‐Warrington V, Apps LD, Bankart J, Sewell L, Williams JE, et al. A self‐management programme for COPD: a randomised controlled trial. European Respiratory Journal 2014;44(6):1538‐47. CENTRAL
Mitchell KE, Warrington V, Sewell L, Bankart J, Williams JE, Steiner MC, et al. A randomised controlled trial of a self‐management programme of activity coping and education ‐ SPACE for COPD: impact on physical activity at 6 weeks [abstract]. American Journal of Respiratory and Critical Care Medicine 2013;187:A5952. CENTRAL
Mitchell‐Wagg K, Warrington V, Apps L, Sewell L, Bankart J, Steiner MC, et al. A self‐management programme of activity coping and education (SPACE) for COPD: results from a randomised controlled trial [abstract]. Thorax 2012;67(Suppl 2):A25. CENTRAL
Wagg K, Warrington V, Apps L, Sewell L, Bankart J, Steiner M, et al. A self‐management programme of activity coping and education (SPACE) for COPD: 6 week results from a randomised controlled trial [abstract]. European Respiratory Journal 2012;40(Suppl 56):548s. CENTRAL
Wagg K, Wilcock E, Williams J, Sewell L, Steiner MC, Morgan M, et al. Pulmonary rehabilitation using the space (a self management programme of activity, coping and education) manual at home: a randomised controlled trial [abstract]. Thorax 2009;64:A97. CENTRAL

Moy 2015a {published data only}

Martinez CH, Moy ML, Nguyen HQ, Cohen M, Kadri R, Roman P, et al. Taking healthy steps: rationale, design and baseline characteristics of a randomized trial of a pedometer‐based internet‐mediated walking program in veterans with chronic obstructive pulmonary disease. BMC Pulmonary Medicine 2014;14:12. CENTRAL
Moy ML, Collins RJ, Martinez CH, Kadri R, Roman P, Holleman RG, et al. An internet‐mediated pedometer‐based program improves health‐related quality‐of‐life domains and daily step counts in COPD: a randomized controlled trial. Chest 2015;148(1):128‐37. CENTRAL
Moy ML, Collins RJ, Martinez CH, Kadri R, Roman P, Holleman RG, et al. An internet‐mediated, pedometer‐based walking program improves HRQOL in veterans with COPD [abstract]. American Journal of Respiratory and Critical Care Medicine 2014;189:A3642. CENTRAL
Moy ML, Martinez CH, Kadri R, Roman P, Holleman RG, Kim HM, et al. Long‐term effects of an internet‐mediated pedometer‐based walking program for chronic obstructive pulmonary disease: randomized controlled trial. Journal of Medical Internet Research 2016;18(8):e215. CENTRAL
Moy ML, Martinez CH, Kadri R, Roman P, Holleman RG, Kim HM, et al. Long‐term effects of an internet‐mediated pedometer‐based walking program in COPD: a randomized controlled trial [abstract]. American Journal of Respiratory and Critical Care Medicine 2015;191:A2457. CENTRAL

Nakamura 2016 {published data only}

Nakamura H, Mori Y, Nanki N, Kamei T. Clinical benefits of aclidinium bromide twice daily compared with tiotropium once daily in patients with moderate to severe chronic obstructive pulmonary disease [abstract]. American Journal of Respiratory and Critical Care Medicine 2017;195:A5471. CENTRAL

NCT00144326 {published data only}

García Río F. A randomised, double‐blind, placebo‐controlled, 12 weeks trial to evaluate the effect of tiotropium inhalation capsules on the magnitude of exercise, measured using an accelerometer, in patients with chronic obstructive pulmonary disease. Boehringer Ingelheim Trial Results2007; Vol. Trial number 205.269 (first received 5 September 2005). CENTRAL

NCT01351792 {published data only}

NCT01351792. Multicentre, randomized research study to test the safety and efficacy of Foster® compared to Symbicort® on small airway function in patients with COPD. Chiesi Clinical Study Report (first received 11 May 2011). [Study number CCD‐1007‐PR‐0045]CENTRAL

Ng 2015 {published and unpublished data}

Ng LW, Jenkins S, Cecins N, Eastwood P, Hill K. A wheeled walker improves physical activity in chronic obstructive pulmonary disease [abstract]. Physiotherapy 2015;101:eS1084. CENTRAL
Ng LW, Jenkins S, Cecins N, Eastwood P, Hill K. The effect of using a wheeled walker on physical activity in people with COPD: preliminary data [abstract]. Respirology 2012;17(Suppl 1):60. CENTRAL

Nguyen 2009 {published data only}

Estrada EL, Silva K, Medina E, Desai S, Fan VS, Nguyen HQ. Depression and anxiety are associated with COPD patients' lower confidence for increasing physical activity but not with their motivation [abstract]. American Journal of Respiratory and Critical Care Medicine 2018;197:A7066. CENTRAL
Lee JS, Liu AI, Pounds D, Mahmud F, Flores C, Desai SA, et al. Characteristics of COPD patients who agree to participate in a pragmatic trial of physical activity coaching compared to non‐participants [abstract]. American Journal of Respiratory and Critical Care Medicine 2018;197:A2642. CENTRAL
Mahmud F, Valmonte F, Medina E, Pounds D, Nguyen HQ. Real‐world implementation of a physical activity coaching program [abstract]. American Journal of Respiratory and Critical Care Medicine 2018;197:A2728. CENTRAL
Nguyen HQ, Gill DP, Wolpin S, Steele BG, Benditt JO. Pilot study of a cell phone‐based exercise persistence intervention post‐rehabilitation for COPD. International Journal of Chronic Obstructive Pulmonary Disease 2009;4:301‐13. CENTRAL

Nolan 2017 {published and unpublished data}

Nolan CM, Maddocks M, Canavan JL, Jones SE, Delogu V, Kaliaraju D, et al. Pedometer step count targets during pulmonary rehabilitation in chronic obstructive pulmonary disease: a randomized controlled trial. American Journal of Respiratory and Critical Care Medicine 2017;195(10):1344‐52. CENTRAL
Nolan CM, Maddocks M, Canavan JL, Jones SE, Delogu V, Kaliaraju D, et al. Pedometer step count targets during pulmonary rehabilitation in chronic obstructive pulmonary disease: a randomized controlled trial [abstract]. American Journal of Respiratory and Critical Care Medicine 2016;193:A7862. CENTRAL
Nolan CM, Maddocks M, Canavan JL, Jones SE, Kon SS, Kaliaraju D, et al. Do pedometers maintain the benefits of pulmonary rehabilitation in COPD patients? [abstract]. European Respiratory Journal 2016;48:PA2058. CENTRAL

O'Neill 2018 {published data only}

O'Neill B, O'Shea OM, McDonough SM, McGarvey L, Bradbury I, Arden MA, et al. Physical activity intervention versus pulmonary rehabilitation in COPD: the LIVELY COPD project [abstract]. Thorax 2016;71(Suppl 3):A20. CENTRAL
O’Neill B, O’Shea OM, McDonough SM, McGarvey L, Bradbury I, Arden MA, et al. Clinician‐facilitated physical activity intervention versus pulmonary rehabilitation for improving physical activity in COPD: a feasibility study. COPD: Journal of Chronic Obstructive Pulmonary Disease 2018;15(3):254‐64. CENTRAL

Ogasawara 2018 {published data only}

Ogasawara T, Marui S, Miura E, Sugiura M, Matsuyama W, Aoshima Y, et al. Effect of eicosapentaenoic acid on prevention of lean body mass depletion in patients with exacerbation of chronic obstructive pulmonary disease: a prospective randomized controlled trial. Clinical Nutrition ESPEN 2018;28:67‐73. CENTRAL

Orme 2018 {published data only}

Orme MW, Weedon AE, Esliger DW, Saukko PM, Morgan MD, Steiner MC, et al. Study protocol for Chronic Obstructive Pulmonary Disease‐Sitting and ExacerbAtions Trial (COPD‐SEAT): a randomised controlled feasibility trial of a home‐based self‐monitoring sedentary behaviour intervention [protocol]. BMJ Open 2016;6:e013014. CENTRAL
Orme MW, Weedon AE, Saukko PM, Esliger DW, Morgan MD, Steiner MC, et al. Findings of the Chronic Obstructive Pulmonary Disease ‐ Sitting and Exacerbations Trial (COPD‐SEAT) in reducing time using wearable and mobile technologies with educational support: randomized controlled feasibility trial. JMIR mHealth and uHealth 2018;6(4):e84. CENTRAL

Polkey 2018 {published data only}

Polkey MI, Qiu ZH, Zhou L, Zhu MD, Wu YX, Chen YY, et al. Tai Chi and pulmonary rehabilitation compared for treatment‐naïve patients with COPD; a randomized controlled trial. Chest 2018;153(3):1116‐24. CENTRAL

Priori 2017 {published and unpublished data}

Priori R, Van Genugten L, Barretto C, Schonenberg H, Stut W, Miller B, et al. Automated coaching for physical activity in COPD patients: results from a pilot study [abstract]. European Respiratory Journal 2017;50:OA4868. CENTRAL
Saini PK, Dekker M, Van Genugten, Prior R, Klee M. Online coaching for physical activity in COPD patients: user engagement and determinants [abstract]. European Respiratory Journal 2018;52:PA3644. CENTRAL
Van Genugten L, Priori R, Barretto C, Schonenberg H, Dekker M, Klee M, et al. An online intervention to maintain physical activity levels in COPD patients after pulmonary rehabilitation [abstract]. Bulletin of the European Health Psychology Society 2016;18:635. CENTRAL

Probst 2011 {published data only}

Probst VS, Kovelis D, Hernandes NA, Camillo CA, Cavalheri V, Pitta F. Effects of 2 exercise training programs on physical activity in daily life in patients with COPD. Respiratory Care 2011;56(11):1799‐807. CENTRAL

Rinaldo 2017 {published data only}

Rinaldo N, Bacchi E, Coratella G, Vitali F, Milanese C, Rossi A, et al. Effects of combined aerobic‐strength training vs fitness education program in COPD patients. International Journal of Sports Medicine 2017;38(13):1001‐8. CENTRAL

Saini 2017 {published data only}

Saini PK, Dekker M, Van Genugten L, Priori R, Klee M. Online coaching for physical activity in COPD patients: user engagement and determinants [abstract]. European Respiratory Journal 2018;52(Suppl 62):PA3644. CENTRAL
Saini PK, Priori R, Barretto C, Delbressine J, Van Genugten L, Dekker M, et al. Activity maintenance after pulmonary rehabilitation ‐ first results of an online coaching program [abstract]. American Journal of Respiratory and Critical Care Medicine 2017;195:A4942. CENTRAL
Van Genugten L, Prior R, Barretto C, Schonenberg H, Dekker M, Klee M, et al. An online intervention to maintain physical activity levels after pulmonary rehabilitation [abstract]. European Health Psychologist2016; Vol. 18. CENTRAL

Sandland 2008 {published data only}

Sandland CJ, Morgan MD, Singh SJ. Patterns of domestic activity and ambulatory oxygen usage in COPD. Chest 2008;134(4):753‐60. CENTRAL

Schuz 2015 {published and unpublished data}

Schuz N, Walters JA, Cameron‐Tucker H, Scott J, Wood‐Baker R, Walters EH. Patient anxiety and depression moderate the effects of increased self‐management knowledge on physical activity: a secondary analysis of a randomised controlled trail on health‐mentoring in COPD. Journal of Chronic Obstructive Pulmonary Disease 2015;12(5):502‐9. CENTRAL
Walters JA, Cameron‐Tucker H, Wills K, Schuz N, Scott J, Robinson A, et al. Effects of telephone health mentoring in community‐recruited chronic obstructive pulmonary disease on self‐management capacity, quality of life and psychological morbidity: a randomised controlled trial. BMJ Open 2013;3(9):e003097. CENTRAL
Walters JA, Wills K, Robinson A, Nelson M, Scott J, Turner P, et al. Effect of health‐mentoring to increase daily physical activity in chronic obstructive pulmonary disease (COPD) [abstract]. Respirology 2012;17:TP079. CENTRAL

Sena 2013 {published and unpublished data}

Sena R, Baril J, Kapchinsky S, MacMillan NJ, Rocha DV, Ruddy R, et al. The effects of eccentric and concentric exercise training on muscle strength in COPD: preliminary results [abstract]. European Respiratory Journal 2012;40(Suppl 56):P482. CENTRAL
Sena R, MacMillan NJ, Baril J, Rocha V, Richard R, Perrault H, et al. Short term effects of eccentric and concentric exercise training on strength muscle, exercise capacity and physical activity in patients with chronic obstructive pulmonary disease [abstract]. Canadian Respiratory Journal 2013;20(2):e36. CENTRAL

Singh 1998 {published data only (unpublished sought but not used)}

Singh SJ, Curcio A, Williams J, Morgan MD, Jones P. Does wearing an activity monitor influence daily activity recorded in patients with COPD? [abstract]. Thorax 1998;53(Suppl 4):A24. CENTRAL

Steele 2019 {published data only}

Kang Y, Steele BG, Burr RL, Dougherty CM. Mortality in advanced chronic obstructive pulmonary disease and heart failure following cardiopulmonary rehabilitation. Biological Research for Nursing 2018;20(4):429‐39. CENTRAL
Steele BG, Dougherty CM, Burr RL, Gylys‐Colwell I, Hunziker J. A feasibility trial of two rehabilitation models in severe cardiopulmonary illness. Rehabilitation Nursing 2019;44(3):130‐40. CENTRAL
Steele BG, Dougherty CM, Burr RL, Gylys‐Colwell I, Hunziker J. An intervention to enhance function in severe cardiopulmonary illness [abstract]. American Journal of Respiratory and Critical Care Medicine 2012;185:A4879. CENTRAL

Tabak 2014a {published data only}

Tabak M, Vollenbroek‐Hutten MM, van der Valk PD, van der Palen H, Hermens HJ. A telerehabilitation intervention for patients with chronic obstructive pulmonary disease: a randomized controlled pilot trial. Clinical Rehabilitation 2014;28(6):582‐91. CENTRAL

Tabak 2014b {published data only}

Tabak M, Brusse‐Keizer M, Van der Valk P, Hermens H, Vollenbroek‐Hutten M. A telehealth program for self‐management of COPD exacerbations and promotion of an active lifestyle: a pilot randomized controlled trial. International Journal of Chronic Obstructive Pulmonary Disease 2014;9:935‐44. CENTRAL

Tahirah 2015 {published and unpublished data}

Tahirah F, Jenkins S, Othman SK, Ismail R, Ismail T, Hill K. A randomised controlled trial of individualised, progressed early exercise in patients hospitalised with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) [abstract]. European Respiratory Journal 2015;46:PA743. CENTRAL

Troosters 2014 {published data only (unpublished sought but not used)}

Sciurba FC, Siafakas NM, Troosters T, Klioze SS, Sutradhar SC, Weisman IM, et al. The efficacy and safety of tiotropium handihaler 18 micrograms once daily plus prn salbutamol versus placebo plus prn salbutamol in COPD subjects naive to maintenance therapy [abstract]. American Journal of Respiratory and Critical Care Medicine 2011;183:A1589. CENTRAL
Troosters T, Sciurba FC, Decramer M, Siafakas NM, Klioze SS, Sutradhar SC, et al. Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo‐controlled trial. Primary Care Respiratory Medicine 2014;24:14003. CENTRAL
Troosters T, Weisman I, Dobbels F, Giardino N, Valluri SR. Assessing the impact of tiotropium on lung function and physical activity in GOLD stage II COPD patients who are naïve to maintenance respiratory therapy: a study protocol. Open Respiratory Medicine Journal 2011;5:1‐9. CENTRAL

Troosters 2018 {published data only}

Bourbeau J, Lavoie KL, Sedano M, De Sousa D, Erzen D, Hamilton A, et al. Behaviour‐change intervention in a multicentre, randomised, placebo‐controlled COPD study: methodological considerations and implementation [protocol]. BMJ Open 2016;6:e010109. CENTRAL
Bourbeau J, Sedeno M, Li PZ, Troosters T, Hamilton A, De Sousa D, et al. Impact of meeting behavioral targets in a self‐management behaviour‐modification program designed to improve physical activity in COPD patients [abstract]. European Respiratory Journal 2017;50:PA4899. CENTRAL
Frith P, Troosters T, Bourbeau J, Maltais F, Leidy N, Erzen D, et al. Effect of tiotropium and olodaterol, alone and with exercise training, on exercise endurance in COPD [abstract]. Respirology 2017;22(Suppl 2):TO048. CENTRAL
Frith P, Troosters T, Lavoie KL, Leidy N, Maltais F, Sedeno M, et al. Bronchodilator therapy and exercise added to self‐management behaviour‐modifications: effects on physical activity in COPD [abstract]. Respirology 2017;22(Suppl 2):TO129. CENTRAL
Lavoie KL, Sedeno M, Li PZ, Troosters T, Hamilton A, De Sousa D, et al. Effects of bronchodilator therapy and exercise with self‐management behaviour‐modification on psychological and cognitive outcomes in COPD [abstract]. European Respiratory Journal 2017;50:OA4669. CENTRAL
Troosters T, Bourbeau J, Maltais F, Leidy N, Erzen D, De Sousa D, et al. Effect of 8 and 12 weeks' once‐daily tiotropium and olodaterol alone and combined with exercise training, on exercise endurance during walking in patients with COPD [abstract]. European Respiratory Journal 2016;48:PA976. CENTRAL
Troosters T, Bourbeau J, Maltais F, Leidy N, Erzen D, De Sousa D, et al. Effect of 8 and 12 weeks' once‐daily tiotropium and olodaterol, alone and combined with exercise training, on exercise endurance during walking in patients with COPD [abstract]. Thorax 2016;71(Suppl 3):A21‐22. CENTRAL
Troosters T, Bourbeau J, Maltais F, Leidy N, Erzen D, De Sousa D, et al. Enhancing exercise tolerance and physical activity in COPD with combined pharmacological and non‐pharmacological interventions: PHYSACTO randomised, placebo‐controlled study design [protocol]. BMJ Open 2016;6:e010106. CENTRAL
Troosters T, Lavoie KL, Leidy N, Maltais F, Sedeno M, Janssens W, et al. Effects of bronchodilator therapy and exercise training, added to a self‐management behaviour‐modification programme, on physical activity in COPD [abstract]. European Respiratory Journal 2016;48:PA713. CENTRAL
Troosters T, Lavoie KL, Leidy N, Maltais F, Sedeno M, Janssens W, et al. Effects of bronchodilator therapy and exercise training, added to a self‐management behaviour‐modification programme, on physical activity in COPD [abstract]. Pneumonologie 2017;71(S01):37. CENTRAL
Troosters T, Maltais F, Leidy N, Lavoie KL, Sedeno M, Janssens A, et al. Effect of bronchodilation and exercise training with behavior modification on exercise tolerance and downstream effects on symptoms and physical activity in COPD. American Journal of Respiratory and Critical Care Medicine 2018;198(8):1021‐32. CENTRAL

Tsai 2016 {published and unpublished data}

Tsai LL, McNamara RJ, Moddel C, Alison JA, McKenzie D, McKeogh ZJ. Home‐based telerehabilitation via real‐time videoconferencing improves endurance exercise capacity in patients with COPD: the randomized controlled TeleR study. Respirology 2017;22(4):699‐707. CENTRAL
Tsai LL, McNamara RJ, Moddel C, Alison JA, McKenzie DK, McKeough ZJ. Home‐based telerehabilitation via real‐time videoconferencing improves endurance exercise capacity in patients with COPD: the randomized controlled TeleR sStudy [abstract]. Respirology 2016;21(S2):TP086. CENTRAL
Tsai LL, McNamara RJ, Moddel C, McKenzie D, Alison JA, McKeough ZJ. Telerehabilitation in people with chronic obstructive pulmonary disease (COPD): a randomised controlled trial [abstract]. European Respiratory Journal 2016;48(Suppl 60):PA2065. CENTRAL

Van de Bool 2017 {published data only}

Van Beers M, Rutten‐van Molken MP, Van de Bool C, Boland M, Kremers SP, Franssen FM, et al. Clinical outcome and cost‐effectiveness of 1‐year nutritional intervention program in COPD [abstract]. European Respiratory Journal 2018;52(Suppl 62):PA723. CENTRAL
Van Beers M, Rutten‐van Molken MP, Van de Bool C, Boland M, Kremers SP, Franssen FM, et al. Clinical outcome and cost‐effectiveness of a 1‐year nutritional intervention programme in COPD patients with low muscle mass: the randomized controlled NUTRAIN trial. Clinical Nutrition 2019;39(2):405‐13. CENTRAL
Van de Bool C, Rutten EP, Van Helvoort A, Franssen FM, Wouters EF, Schols AM. A randomized clinical trial investigating the efficacy of targeted nutrition as adjunct to exercise training in COPD. Journal of Cachexia, Sarcopenia and Muscle 2017;8(5):748‐58. CENTRAL
Van de Bool C, Van Helvoort A, Franssen FM, Wouters EF, Schols AM. Physiological effects of nutritional supplementation as adjunct to exercise training in COPD patients with low muscle mass. The double blind, placebo controlled multi‐centre NUTRAIN‐trial [abstract]. European Respiratory Journal 2016;48(Suppl 60):OA266. CENTRAL

Varas 2018 {published and unpublished data}

Varas AB, Cordoba S, Rodriguez‐Andonaegui I, Rueda MR, Garcia‐Juez S, Vilaro J. Effectiveness of a community‐based exercise training programme to increase physical activity level in patients with chronic obstructive pulmonary disease: a randomized controlled trial. Physiotherapy Research International 2018;23(4):e1740. CENTRAL

Vasilopoulou 2017 {published and unpublished data}

Vasilopoulou M, Papaioannou AI, Chynkiamis N, Vasilogiannakopoulou T, Spetsioti S, Louvaris Z, et al. Effectiveness of home telerehabilitation on functional capacity and daily physical activity in COPD patients [abstract]. European Respiratory Journal 2015;46:OA273. CENTRAL
Vasilopoulou M, Papaioannou AI, Kaltsakas G, Louvaris Z, Chynkiamis N, Spetsioti S, et al. Home‐based maintenance tele‐rehabilitation reduces the risk of acute exacerbations of COPD, hospitalisations and emergency department visits. European Respiratory Journal 2017;49(5):pii:1602129. CENTRAL

Vorrink 2016 {published data only}

Vorrink S, Huisman C, Kort H, Troosters T, Lammers JW. Perceptions of patients with chronic obstructive pulmonary disease and their physiotherapists regarding the use of an ehealth intervention. JMIR Human Factors 2017;4(3):e20. CENTRAL
Vorrink SN, Kort HS, Troosters T, Zanen P, Lammers JL. Efficacy of an mHealth intervention to stimulate physical activity in COPD patients after pulmonary rehabilitation. European Respiratory Journal 2016;48(4):1019‐29. CENTRAL

Wan 2017 {published and unpublished data}

Kantorowski A, Wan ES, Homsy D, Kadri R, Richardson CR, Moy ML. Determinants and outcomes of change in physical activity in COPD. ERJ Open Research 2018;4(3):pii: 00054‐2018. CENTRAL
Robinson SA, Shimada SL, Quigley KS, Moy ML. A web‐based physical activity intervention benefits persons with low self‐efficacy in COPD: results from a randomized controlled trial. Journal of Behavioral Medicine 2019;42(6):1082‐90. CENTRAL
Wan ES, Kantorowski A, Homsy D, Kadri R, Richardson CR, Mori D, et al. Self‐reported task‐oriented physical activity: a comparison with objective daily step count in COPD. Respiratory Medicine 2018;140:63‐70. CENTRAL
Wan ES, Kantorowski A, Homsy D, Teylan M, Kadri R, Richardson CR, et al. Promoting physical activity in COPD: insights from a randomized trial of a web‐based intervention and pedometer use. Respiratory Medicine 2017;130:102‐10. CENTRAL
Wan ES, Kantorowski A, Teylan M, Kadri R, Richardson CR, Garshick E, et al. Patterns of change in daily step count among COPD patients enrolled in a 3‐month physical activity intervention [abstract]. American Journal of Respiratory and Critical Care Medicine 2017;195:A4939. CENTRAL

Watz 2016 {published and unpublished data}

Watz H, Mailaender C, Kirsten AM. Effects of indacaterol/glycopyrronium on lung function and physical activity in patients with moderate to severe COPD [abstract]. Thorax 2015;70:A146‐7. CENTRAL
Watz H, Mailander C, Baier M, Kirsten AM. Effects of indacaterol/glycopyrronium (QVA149) on lung hyperinflation and physical activity in patients with moderate to severe COPD: a randomised, placebo‐controlled, crossover study (The MOVE Study). BMC Pulmonary Medicine 2016;16(1):95. CENTRAL

Watz 2017 {published data only}

Watz H, Troosters T, Beeh KM, Garcia Aymerich J, Paggiaro P, Molins E, et al. ACTIVATE: effect of aclidinium/formoterol on physical activity in patients with COPD [abstract]. European Respiratory Journal 2017;60(Suppl 61):PA687. CENTRAL
Watz H, Troosters T, Beeh KM, Garcia Aymerich J, Paggiaro P, Molins E, et al. Effect of aclidinium/formoterol on lung hyperinflation, exercise capacity and physical activity in patients with COPD: results from ACTIVATE, a phase IV study [abstract]. American Journal of Respiratory and Critical Care Medicine 2017;195:A3593. CENTRAL
Watz H, Troosters T, Beeh KM, Garcia‐Aymerich J, Paggiaro P, Molins E, et al. ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity and physical activity in patients with COPD. International Journal of Chronic Obstructive Pulmonary Disease 2017;12:2545‐58. CENTRAL

Widyastuti 2018 {published data only}

Widyastuti K, Makhabah DN, Rima A, Sutanto YS, Suradi S, Ambrosino N. Home based pulmonary rehabilitation with pedometers in Indonesian COPD patients [abstract]. European Respiratory Journal 2017;50:PA777. CENTRAL
Widyastuti K, Makhabah DN, Rima Setijadi A, Sutanto YS, Suradi S, Ambrosino N. Benefits and costs of home pedometer assisted physical activity in patients with COPD: a preliminary randomized controlled trial. Pulmonology 2018;24(4):211‐8. CENTRAL

Wootton 2017 {published and unpublished data}

Hill K, Wootton SL, Ng LW, Jenkins S, Cecins N, Straker L, et al. High‐intensity ground‐based walking does not change time spent in physical activity or sedentary behaviour in people with chronic obstructive pulmonary disease [abstract]. Respirology 2016;21(Suppl 2):TP083. CENTRAL
Watts SL, Ng LW, McKeogh ZJ, Jenkins S, Hill K, Eastwood PR, et al. Effects of ground walking training in COPD: a randomized controlled trial [abstract]. Respirology 2013;18(Suppl 2):O064. CENTRAL
Wootton SL, Hill K, Alison JA, Ng LW, Jenkins S, Eastwood PR, et al. Effects of ground‐based walking training on daily physical activity in people with COPD: a randomised controlled trial. Respiratory Medicine 2017;132:139‐45. CENTRAL
Wootton SL, Hill K, Alison JA, Ng LW, Jenkins S, Eastwood PR, et al. Effects of ongoing feedback during a 12‐month maintenance walking program on daily physical activity in people with COPD. Lung 2019;197(3):315‐9. CENTRAL
Wootton SL, Ng LW, McKeough ZJ, Jenkins S, Hill K, Eastwood PR, et al. Ground walking training in chronic obstructive pulmonary disease: a randomised controlled trial [abstract]. American Journal of Respiratory and Critical Care Medicine 2014;189:A4162. CENTRAL
Wootton SL, Ng LW, McKeough ZJ, Jenkins S, Hill K, Eastwood PR, et al. Ground‐based walking training improves quality of life and exercise capacity in COPD. European Respiratory Journal 2014;44(4):885‐94. CENTRAL

Referencias de los estudios excluidos de esta revisión

ACTRN12611001034921 {published data only}

ACTRN12611001034921. A randomised controlled clinical trial in adults with Chronic Obstructive Pulmonary Disease on the effect of telephone health‐mentoring, home‐based walking and rehabilitation compared with rehabilitation only on health‐related quality of life. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=343303 (first received 29 November 2011). CENTRAL

Aksu 2006 {published data only}

Aksu B, Inanir M, Basyigit I, Dursun N, Yildiz F. Comparison of two different exercise programs in chronic obstructive pulmonary disease [abstract]. European Respiratory Journal 2006;28(Suppl 50):555s. CENTRAL

Arnedillo 1998 {published data only}

Arnedillo A, Puente L, Mangas A, Leaan A. Comparison of two exercise training programmes in patients with chronic obstructive pulmonary disease [abstract]. Neumosur 1998;10(4):223‐9. CENTRAL

Atkins 1984 {published data only}

Atkins CJ, Kaplan RM, Timms RM, Reinsch S, Lofback K. Behavioral exercise programs in the management of chronic obstructive pulmonary disease. Journal of Consulting and Clinical Psychology 1984;52(4):591‐603. CENTRAL

Barnes‐Harris 2019 {published data only}

Barnes‐Harris M, Allgar V, Booth S, Currow D, Hart S, Phillips J, et al. Battery operated fan and chronic breathlessness: does it help?. BMJ Supportive and Palliative Care 2019;May 8:pii: bmjspcare‐2018‐001749. CENTRAL

Bartlett 2017 {published data only}

Bartlett YK, Webb TL, Hawley MS. Using persuasive technology to increase physical activity in people with chronic obstructive pulmonary disease by encouraging regular walking: a mixed‐methods study exploring opinions and preferences. Journal of Medical Internet Research 2017;19(4):e124. CENTRAL

Baumann 2006 {published data only}

Baumann HJ, Rummel K, Schmoller T, Meyer A. Efficacy of a long term ambulatory interdisciplinary rehabilitation (AIR) program in moderate to severe COPD [abstract]. European Respiratory Journal 2006;28(Suppl 50):555s. CENTRAL

Behnke 2000 {published data only}

Behnke M. The effects of a home‐based exercise training programme in patients with chronic obstructive lung disease. Pneumologie 2000;53:2‐3. CENTRAL

Behnke 2005 {published data only}

Behnke M, Wewel AR, Kirsten D, Jorres RA, Magnussen H. Exercise training raises daily activity stronger than predicted from exercise capacity in patients with COPD. Respiratory Medicine 2005;99(6):711‐7. CENTRAL

Bernardi 2017 {published data only}

Bernardi E, Merlo C, Bellotti F, Grazzi G, Cogo A. An exercise training program improves endothelial function in COPD patients [abstract]. European Respiratory Journal 2017;50(Suppl 61):OA1959. CENTRAL

Bertici 2013 {published data only}

Bertici N, Fira‐Mladinescu O, Oancea C, Tudorache V. The usefulness of pedometry in patients with chronic obstructive pulmonary disease. Multidisciplinary Respiratory Medicine 2013;8(1):7. CENTRAL

Biscione 2009 {published data only}

Biscione G, Crigna G, Auciello L, Pasqua F, Cazzola M. Addition of tiotropium (T) to a regular treatment with long‐acting beta‐agonist + inhaled corticosteroid (LABA + ICS) in patients with severe to very‐severe COPD under in‐patient pulmonary rehabilitation program (PRP) [abstract]. European Respiratory Society 19th Annual Congress; 2009 Sep 12‐15; Vienna. 2009:P526. CENTRAL

Bohning 1990 {published data only}

Bohning W, Wettengel R. Physical exercise training in COPD during a 4 ‐week rehabilitation programme [abstract]. European Respiratory Journal 1990;3(Suppl 10):212S. CENTRAL

Boland 2015 {published data only}

Boland MR, Tsiachristas A, Rutten van Molken M. COPD performance indicators in an integrated care program and its impact on health outcomes: The Recode Cluster Randomized Trial [abstract]. Value in Health 2015;18(7):A505. CENTRAL
Kruis AL, Boland MR, Assendelft WJ, Gussekloo J, Tsiachristas A, Stijnen T, et al. Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: Results of cluster randomised trial. BMJ 2014;349(7976):g5392. CENTRAL

Börekçi 2008 {published data only}

Börekçi S, Elci A, Ovayolu N, Elbeck O. Applicability and efficacy of the pulmonary rehabilitation program for COPD patients in a secondary‐care community hospital [Abstract]. American Thoracic Society International Conference; 2008 May 16‐21; Toronto. 2008; Vol. 5, issue 5:P416. CENTRAL

Borges 2012 {published data only}

Borges RC, Carvalho CR. Physical activity in daily life in Brazilian COPD patients during and after exacerbation. Chronic Obstructive Pulmonary Disease 2012;9(6):596‐602. CENTRAL

Bourbeau 2000 {published data only}

Bourbeau J, Julien M, Rouleau M, Maltais F, Beaupre A, Begin R, et al. Impact of an integrated rehabilitative self‐management program on health status of COPD patients: a multicentre randomised clinical trial [abstract]. European Respiratory Journal 2000;16(Suppl 31):159s. CENTRAL

Budnevskiy 2015 {published data only}

Budnevskiy AV, Chernov AV, Isaeva YV, Yu Malysh E. Clinical efficacy of pulmonary rehabilitation program in patients with chronic obstructive pulmonary disease and metabolic syndrome. Pulmonologiya 2015;25(4):447‐55. CENTRAL

Bunker 2012 {published data only}

Bunker JM, Reddel HK, Dennis SM, Middleton S, Van Schayck C, Crockett AJ, et al. A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse‐general practitioner teams: study protocol. Implementation Science 2012;7:83. CENTRAL

Bustamante 2013 {published data only}

Bustamante V, Lopez de Santamaria E, Marina N, Gorostiza A, Fernandez Z, Galdiz J. Neuromuscular magnetic stimulation of the quadriceps muscle after COPD exacerbations. European Respiratory Journal 2013;42:P3572. CENTRAL

Camillo 2011 {published data only}

Camillo CA, Laburu V de M, Gonçalves NS, Cavalheri V, Tomasi FP, Hernandes NA, et al. Improvement of heart rate variability after exercise training and its predictors in COPD. Respiratory Medicine 2011;105(7):1054‐62. CENTRAL

Cebollero 2018 {published data only}

Cebollero P, Anton M, Hernandez M, Hueto J. Walking program for COPD patients: clinical impact after two years of follow‐up [Programa de paseos para pacientes con EPOC: impacto clínico tras 2 anos de seguimiento]. Archivos de Bronconeumología 2018;54(8):431‐3. CENTRAL
Hernandez Bonaga M, Zambom F, Cascante JA, Hueto J, Anton M, Cebollero Rivas P. Walking guide for COPD patients: a promoter of physical activity?. European Respiratory Journal 2014;44:p3681. CENTRAL
Hernandez M, Zambom F, Cascante JA, Hueto J, Anton M, Cebollero P. Walking guide for COPD patients: can be used as a promoter of physical activity?. European Respiratory Journal 2013;42:p3703. CENTRAL
Hernandez M, Zambom‐Ferraresi F, Milagros Anton M, Hueto J, Cascante J, Cebollero P. Short and long term effects of a physical activity programa in COPD patients. European Respiratory Journal 2015;46(Suppl 59):PA 2213. CENTRAL

Chen 2018 {published data only}

Chen K‐Y, Hung M‐H, Chang M‐C, Kuo C, Lin C‐M, Chuang L‐P, et al. Four‐weeks remote pulmonary rehabilitation protocol with mobile apps of real‐time heart rate monitoring for gold category B/C/D‐A study design. Respirology 2018;23(Suppl 2):82. CENTRAL

Corrado 1995 {published data only}

Corrado A, Gorini M, De Paola E, Martorana P, Villella G, Augustynen A, et al. Effects of a short outpatient pulmonary rehabilitation program (PRP) in severe COPD patients with chronic respiratory insufficiency (CRI) [abstract]. European Respiratory Journal 1995;8(Suppl 19):126s. CENTRAL

Coultas 2011 {published data only}

Coultas D, Sloan J, Wilson D. Pilot study of effectiveness of home rehabilitation for homebound patients with severe COPD [abstract]. European Respiratory Society 21st Annual Congress; 2011 Sep 24‐28; Amsterdam. 2011:881s. CENTRAL

Coultas 2017 {published data only}

Ashmore J, Russo R, Peoples J, Sloan J, Jackson BE, Bae S, et al. Chronic obstructive pulmonary disease self‐management activation research trial (COPD‐SMART): design and methods. Contemporary Clinical Trials 2013;35(2):77‐86. CENTRAL
Coultas D, Russo R, Peoples J, Ashmore J, Sloan J, Jackson B, et al. A lifestyle physical activity intervention is associated with decline in health care utilization (HCU) among patients with COPD [abstract]. European Respiratory Journal 2014;44(Suppl 58):P611. CENTRAL
Coultas DB, Jackson BE, Russo R, Peoples J, Singh KP, Sloan J, et al. Home‐based physical activity coaching, physical activity, and healthcare utilization in COPD: COPD‐SMART secondary outcomes. Annals of the American Thoracic Society 2018;15(4):470‐8. CENTRAL
Russo R, Coultas D, Ashmore J, Peoples J, Sloan J, Jackson BE, et al. Chronic obstructive pulmonary disease self‐management activation research trial (COPD‐SMART): results of recruitment and baseline patient characteristics. Contemporary Clinical Trials 2015;41C:192‐201. CENTRAL

De Backer 2014 {published data only}

De Backer W, Vos W, Van Holsbeke C, Vinchurkar S, Claes R, Hufkens A, et al. The effect of roflumilast in addition to LABA/LAMA/ICS treatment in COPD patients [abstract]. European Respiratory Journal 2014;44(2):527‐9. CENTRAL

Deering 2011 {published data only}

Deering BM, Fullen B, Egan C, McCormack N, Kelly E, Pender M, et al. Acupuncture as an adjunct to pulmonary rehabilitation. Journal of Cardiopulmonary Rehabilitation and Prevention 2011;31(6):392‐9. CENTRAL

De Souza 2017 {published data only}

De Souza Y, Da Sliva KM, Condesso D, Figueira B, Alves RR, Costa CH, et al. Home‐based pulmonary rehabilitation intervention: does it maintain the benefits achieved during the outpatient program [abstract]. American Journal of Respiratory and Critical Care Medicine 2017;195:A941. CENTRAL

Durheim 2015 {published data only}

Durheim MT, Smith PJ, Babyak MA, Mabe SK, Emery CF, Blumenthal JA, et al. Physical function as measured by 6‐minute walk distance or accelerometry predicts clinical outcomes in COPD patients independent of GOLD 2011 [abstract]. American Journal of Respiratory and Critical Care Medicine 2014;189:A6679. CENTRAL
Durheim MT, Smith PJ, Babyak MA, Mabe SK, Martinu T, Welty‐Wolf KE, et al. Six‐minute‐walk distance and accelerometry predict outcomes in chronic obstructive pulmonary disease independent of Global Initiative for Chronic Obstructive Lung Disease 2011 Group. Annals of the American Thoracic Society 2015;12(3):349‐56. CENTRAL

Dyer 2011 {published data only}

Dyer F, Flude L, Bazari F, Jolley C, Englebretsen C, Lai D, et al. Non‐invasive ventilation (NIV) as an aid to rehabilitation in acute respiratory disease. BMC Pulmonary Medicine 2011;11:58. CENTRAL

EUCTR2016‐003675‐21‐ES {published data only}

EUCTR2016‐003675‐21‐ES. A study to test different doses of Danirixin in patients with COPD. www.clinicaltrialsregister.eu/ctr‐search/trial/2016‐003675‐21/results (first received 18 April 2017). CENTRAL

Faulkner 2010 {published data only}

Faulkner J, Walshaw E, Campbell J, Jones R, Taylor R, Price D, et al. The feasibility of recruiting patients with early COPD to a pilot trial assessing the effects of a physical activity intervention. Primary Care Respiratory Journal 2010;19(2):124‐30. CENTRAL

Fernandez 1998 {published data only}

Fernandez J, Martin M, Moreno LF. Evaluation of a home‐based rehabilitation program controlled with pulse‐meter in COPD. Neumosur 1998;10(1):54‐5. CENTRAL

Foy 2006 {published data only}

Foy CG, Wickley KL, Adair N, Lang W, Miller ME, Rejeski WJ, et al. The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): Rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease. Contemporary Clinical Trials 2006;27(2):135‐46. CENTRAL

Friis 2017 {published data only}

Friis AL, Steenholt CB, Lokke A, Hansen M. Dietary beetroot juice ‐ effects on physical performance in COPD patients: a randomized controlled crossover trial. International Journal of Chronic Obstructive Pulmonary Disease 2017;12:1765‐73. CENTRAL

Furness 2014 {published data only}

Furness T, Joseph C, Naughton G, Welsh L, Lorenzen C. Benefits of whole‐body vibration to people with COPD: a community‐based efficacy trial. BMC Pulmonary Medicine 2014;14(1):38. CENTRAL

Garcia Aymerich 2016 {published data only}

Garcia Aymerich J, Puham M, De Jongh C, Demeyer H, Erzen D, Gimeno Santos E, et al. Responsiveness of PROactive instruments to measure physical activity in COPD patients [abstract]. European Respiratory Journal 2016;48:PA1896. CENTRAL

Gohl 2004 {published data only}

Gohl O, Linz H, Otte B, Schonleben T, Weineck J, Worth H. Benefits of a multicomponent outpatient rehabilitation program for patients with chronic obstructive pulmonary disease [abstract]. American Thoracic Society 100th International conference; 2004 May 21‐26; Orlando. 2004:D14. CENTRAL
Gohl O, Linz H, Otte B, Schonleben T, Weineck J, Worth H. Effects of multicomponent outpatient rehabilitation program for patients with COPD [abstract]. European Respiratory Journal 2004;24(Suppl 48):208s. CENTRAL

Gohl 2006 {published data only}

Gohl O, Schacher C, Grensemann S, Worth H. Effects of inspiratory muscle training with the RESPIFIT S in addition to an outpatient exercise training program for patients with COPD [abstract]. European Respiratory Journal 2006;28(Suppl 50):556s. CENTRAL

Gomez 2006 {published data only}

Gomez A, Roman M, Larraz C, Esteva M, Mir I, Thomas V, et al. Efficacy of respiratory rehabilitation on patients with moderate COPD in primary care and maintenance of benefits at 2 years. Atencion Primaria / Sociedad Espanola de Medicina de Familia y Comunitaria 2006;38(4):230‐3. CENTRAL

Gosselink 1990 {published data only}

Gosselink H, Van Keimpema A, Wagenaar R, Chadwick Straver R. The relative efficacy of a rehabilitation‐programme in COPD patients [abstract]. European Respiratory Journal 1990;10(Suppl 10):212S. CENTRAL

Grabenhorst 2013 {published data only}

Grabenhorst M, Jehn M, Maldener N, Liebers U, Kohler F, Witt C. Telemedicine in patients with COPD: Feasibility and benefit of regular exercise testing via remote patient monitoring [abstract]. Pneumologie 2013;67:P377. CENTRAL

Greulich 2013 {published data only}

Greulich T, Augsten M, Kehr K, Nell C, Koehler U, Werner J. A randomized clinical trial to assess the influence of a three months training program (individualized vs. non‐individualized) in patients with moderate to very severe COPD [abstract]. American Journal of Respiratory and Critical Care Medicine 2012;185:A4874. CENTRAL
Greulich T, Kehr K, Nell C, Haid D, Koehler U, Koehler K, et al. A randomized clinical trial comparing the influence of two different training modalities (individualized vs. non‐individualized) in patients with moderate to very severe COPD [abstract]. American Journal of Respiratory and Critical Care Medicine 2013;187:A1801. CENTRAL

Guell 2008 {published data only}

Guell MR, De Lucas P, Galdiz JB, Montemayor T, Gonzalez‐Moro JM, Gorostiza A, et al. Home versus hospital‐based pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: a Spanish multicenter trial. Archivos de Bronconeumología 2008;44(10):512‐8. CENTRAL
Guell R, Delucas P, Galdiz JB, Montemayor T, Rodriguez JM, Gorostiza A, et al. Effectiveness of a home based pulmonary rehabilitation program compared to a hospital based pulmonary rehabilitation program in COPD patients, a Spanish multicenter randomized trial [abstract]. European Respiratory Journal 2006;28(Supp 50):298s. CENTRAL

Gurgun 2011 {published data only}

Gurgun A, Tuncel S, Korkmaz Ekren P, Deniz PS, Karapolat H, Kayahan B. Efficacy of an eight‐week pulmonary rehabilitation in COPD patients: an experience of a single center in Turkey [abstract]. American Journal of Respiratory and Critical Care Medicine 2011;183:A5049. CENTRAL

Hartman 2012 {published data only}

Hartman JE, Boezen M, Heintzbergen S, De Greef MH, Klooster K, Ten Hacken NH, et al. Daily physical activity after bronchoscopic lung volume reduction: a pilot study. European Respiratory Journal 2012;40:1566‐7. CENTRAL

Hataji 2017 {published data only}

Hataji O, Nishii Y, Ito K, Sakaguchi T, Saiki H, Suzuki Y, et al. Smart watch‐based coaching with tiotropium and olodaterol ameliorates physical activity in patients with chronic obstructive pulmonary disease. Experimental and Therapeutic Medicine 2017;14(5):4061‐4. CENTRAL

Herrejon 2010 {published data only}

Herrejon A, Catalan P, Palop J, Inchaurraga I, Blanquer R, Lopez A, et al. Effect of 8‐week 320 mg Megestrol acetate daily administration In severe COPD and weight loss [abstract]. American Journal of Respiratory and Critical Care Medicine 2010;181:A4484. CENTRAL

Hillegass 2012 {published data only}

Hillegass E, Hayes D, Sanders D, Owens T, Langbehn C, Johnson M, et al. Continuous versus pulsed oxygen: is there a difference with activity? A pilot study [abstract]. Chest 2012;142(4):802A. CENTRAL

Horton 2018 {published data only}

Horton EJ, Mitchell KE, Johnson‐Warrington V, Apps LD, Sewell L, Morgan M, et al. Comparison of a structured home‐based rehabilitation programme withe conventional supervised pulmonary rehabilitation: a randomised non‐inferiority trial. Thorax 2018;73:29‐36. CENTRAL

Ichinose 2017 {published data only}

Ichinose M, Minakata Y, Motegi T, Ueki J, Gon Y, Seki T. Efficacy of tiotropium/olodaterol on lung volume, exercise capacity, and physical activityet al. International Journal of Chronic Obstructive Pulmonary Disease 2018;13:1407‐19. CENTRAL
Ichinose M, Minakata Y, Motegi T, Ueki J, Gon Y, Seki T, et al. Efficacy of tiotropium/olodaterol on lung hyperinflation, exercise capacity, and physical activity in Japanese patients with Chronic Obstructive Pulmonary Disease (VESUTO Study): a randomized crossover trial [abstract]. American Journal of Respiratory and Critical Care Medicine 2018;197:A4243. CENTRAL
Ichinose M, Minakata Y, Motegi T, Ueki J, Seki T, Anzai T, et al. Study design of VESUTO: efficacy of tiotropium/olodaterol on lung hyperinflation, exercise capacity and physical activity in Japanese patients with chronic obstructive pulmonary disease. Advances in Therapy 2017;34(7):1622‐35. CENTRAL
Ichinose M, Minakata Y, Motegi T, Ueki J, Seki T, Anzai T, et al. Study design of VESUTO; study to evaluate the efficacy of tiotropium + olodaterol vs tiotropium on lung hyperinflation, exercise capacity, and physical activity in Japanese COPD patients [abstract]. Respirology 2016;21(S3):APSR6‐0457. CENTRAL
Minakata Y, Motegi T, Ueki J, Gon Y, Seki T, Anzai T, et al. Efficacy of tiotropium/olodaterol on sedentary/active time in COPD patients: VESUTO study [abstract]. European Respiratory Journal 2018;52(Suppl 62):PA4390. CENTRAL

Ides 2012 {published data only}

Ides KM, De Backer L, Daems D, Boelen E, Leemans G, Vissers D, et al. Preliminary results of noninvasive ventilation during a pulmonary rehabilitation program in patients with COPD [abstract]. European Respiratory Journal 2012;50(Suppl 56):639s. CENTRAL

Innocenti 2000 {published data only}

Innocenti F, Fabbri A, Guerrini M, Fonseca D, Lippi P. Results of an outpatient pulmonary rehabilitation program in patients with COPD [abstract]. European Respiratory Journal 2000;16(Suppl 31):46s. CENTRAL

Johnson‐Warrington 2016 {published data only}

Johnson‐Warrington V, Rees K, Gedler C, Morgan MD, Singh SJ. Can a supported self‐management program for COPD upon hospital discharge reduce readmissions? A randomized controlled trial. International Journal of Chronic Obstructive Pulmonary Disease 2016;11:1161‐9. CENTRAL

Jonsdottir 2015 {published data only}

Jonsdottir H, Amundadottir OR, Gudmundsson G, Halldorsdottir BS, Hrafnkelsson B, Ingadottir TS, et al. Effectiveness of a partnership‐based self‐management programme for patients with mild and moderate chronic obstructive pulmonary disease: a pragmatic randomized controlled trial. Journal of Advanced Nursing 2015;71(11):2634‐49. CENTRAL

Kato 2017 {published data only}

Kato D, Dobashi K, Fueki M, Tomioka S, Yamada H, Fueki N. Short‐term and long‐term effects of a self‐managed physical activity program using a pedometer for chronic respiratory disease: a randomized controlled trial. Journal of Physical Therapy Science 2017;89:807‐12. CENTRAL

Kim 2003 {published data only}

Kim DS, Na JO, Jegal YJ, Yoon SH, Shim TS, Lim CM, et al. Efficacy of home based pulmonary rehabilitation program for the patients with chronic lung diseases [abstract]. European Respiratory Journal 2003;22(Suppl 45):A1082. CENTRAL

Kruis 2014 {published data only}

Kruis AL, Boland MR, Assendelft WJ, Gussekloo J, Tsiachristas A, Stijnen T, et al. Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: Results of cluster randomised trial. BMJ Online 2014;349(7976):g5392. CENTRAL

Langer 2018 {published data only}

Langer D, Ciavaglia C, Faisal A, Webb KA, Neder JA, Gosselink R, et al. Inspiratory muscle training reduces diaphragm activation and dyspnea during exercise in COPD. Journal of Applied Physiology 2018;125(2):381‐92. CENTRAL

Larraz 2010 {published data only}

Larraz C, Esteva M, Ripoll J, Mir I, Gómez A, Román M. Efficacy of a rehabilitation program on moderate COPD conducted in primary care and the maintenance of benefits during two years [abstract]. Primary Care Respiratory Journal 2010;19(2):A22. CENTRAL

Lee 2007 {published data only}

Lee KH, Shin KC, Chung JH, Yu SK. Effects of self‐efficacy promoting pulmonary rehabilitation program for chronic obstructive pulmonary disease patients [abstract]. American Thoracic Society International Conference; 2007 May 18‐23; San Francisco. 2007:M60. CENTRAL

Liang 2018 {published data only}

Liang J, Abramson M, Zwar N, Russell G, Holland A, Bonevski B, et al. An interdisciplinary model of care for the early detection and management of chronic obstructive pulmonary disease (COPD) in primary care‐the RADICALS trial [abstract]. Respirology 2016;21(Suppl 2):61. CENTRAL
Liang J, Abramson MJ, Zwar NA, Russell GM, Holland AE, Bonevski M, et al. Diagnosing COPD and supporting smoking cessation in general practice: evidence–practice gaps. Medical Journal of Australia 2018;208(1):29‐34. CENTRAL

Liu 2019 {published data only}

Liu X, Li P, Xiao L, Lu Y, Li N, Wang Z, et al. Effects of home‐based prescribed pulmonary exercise by patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial. Trials 2019;20(1):41. CENTRAL

Lum 2007 {published data only}

Lum CM, Woo J, Yeung F, Hui DS, Hui E. Semi‐supervised, domiciliary pulmonary rehabilitation programme: a controlled clinical trial. Hong Kong Medical Journal 2007;13(Suppl 5):42‐5. CENTRAL

Mahesh 2017 {published data only}

Mahesh PA, Srikanth JN, Ananthakrishna MS, Parthasarathi G, Chaya SK, Rajgopal R, et al. Amelioration of quality of life and lung function of chronic obstructive pulmonary disease by pranic healing as adjuvant therapy: a randomised double blind placebo controlled pilot study. Australasian Medical Journal 2017;10(8):665‐73. CENTRAL

Marques 2019 {published data only}

Marques A, Jacome C, Rebelo P, Paixao C, Oliveira A, Cruz J, et al. Improving access to community‐based pulmonary rehabilitation: 3R protocol for real‐world settings with cost‐benefit analysis. BMC Public Health 2019;19(1):676. CENTRAL

Martinez 2008 {published data only}

Martinez G, Thogersen J, Brondum E, Ringaek T, Lange P. Effect of maintenance training after 7 weeks rehabilitation programme [abstract]. European Respiratory Society 18th Annual Congress; 2008 Oct 3‐7; Berlin. 2008:E2805. CENTRAL

McGlone 2006 {published data only}

McGlone S, Venn A, Walters EH, Wood‐Baker R. Physical activity, spirometry and quality‐of‐life in chronic obstructive pulmonary disease. COPD 2006;3(2):83‐8. CENTRAL

McMahon 2000 {published data only}

McMahon S, Small T, Higgins BG, Corris PA. The use of a novel patient activity monitor to assess the therapeutic effect of adding salmeterol to regular therapy in patients with chronic obstructive pulmonary disease [abstract]. Thorax 2000;55(Suppl 3):A40. CENTRAL

Mesquita 2017 {published data only}

Mesquita R, Meijer K, Pitta F, Azcuna H, Goertz YM, Essers JM, et al. Changes in physical activity and sedentary behaviour following pulmonary rehabilitation in patients with COPD. Respiratory Medicine 2017;126:122‐9. CENTRAL

Moore 2009 {published data only}

Moore R, Berlowitz D, Denehy L, Jackson B, McDonald CF. Comparison of pedometer and activity diary for measurement of physical activity in chronic obstructive pulmonary disease. Journal of Cardiopulmonary Rehabilitation and Prevention 2009;29(1):57‐61. CENTRAL

Morris 2012 {published data only}

Atkinson C, Seale H, Walsh J, Adams L, Morris NR. The addition of a pedometer‐guided intervention to pulmonary rehabilitation fails to improve physical activity levels in individuals with COPD [abstract]. Respirology 2012;17(Suppl 1):64. CENTRAL
Morris NR, Atkinson C, Seale H, Walsh J. The addition of a pedometer guided intervention to pulmonary rehabilitation [abstract]. American Journal of Respiratory and Critical Care Medicine 2012;185:A2383. CENTRAL

Moy 2009 {published data only}

Moy ML, Matthess K, Stolzmann K, Reilly J, Garshick E. Free‐living physical activity in COPD: assessment with accelerometer and activity checklist. Journal of Rehabilitation Research and Development 2009;46(2):277‐86. CENTRAL

Moy 2012 {published data only}

Moy ML, Weston NA, Wilson EJ, Hess ML, Richardson CR. A pilot study of an Internet walking program and pedometer in COPD. Respiratory Medicine 2012;106(9):1342‐50. CENTRAL

Murphy 2005 {published data only}

Murphy MC, Campbell M, Saunders JE, Jackson B. A randomized trial to compare the outcomes of a pulmonary rehabilitation program (PRP) weekly maintenance and the Stanford Model Chronic Disease Self Management Program (CDSMP) in COPD [abstract]. American Thoracic Society International Conference; 2005 May 20‐25; San Diego. 2005:A26. CENTRAL

Nagata 2018 {published data only}

Nagata K, Kikuchi T, Horie T, Shiraki A, Kitajima T, Kadowaki T, et al. Domiciliary high‐flow nasal cannula oxygen therapy for patients with stable hypercapnic Chronic Obstructive Pulmonary Disease. A multicenter randomized crossover trial. Annals of the American Thoracic Society 2018;15(4):422‐39. CENTRAL
Nagata K, Kikuchi T, Horie T, Shiraki A, Kitajima T, Kadowaki T, et al. Domiciliary high‐flow nasal cannula oxygen therapy for stable hypercapnic chronic obstructive pulmonary disease: a prospective, multicentre, randomised crossover trial [abstract]. European Respiratory Journal 2017;50:OA4428. CENTRAL

NCT00620022 {published data only}

O'Donnell D, Casaburi R, Vincken W, Puente‐Maestu L, Swales J, Lawrence D, et al. Effect of indacterol on exercise endurance and lung hyperinflation in COPD. Respiratory Medicine 2011;105(7):1030‐6. CENTRAL

NCT01012765 {published data only}

Watz H, Krippner F, Kirsten A, Magnussen H, Vogelmeier C. Effects of indacaterol on lung volumes and physical activity In moderate chronic obstructive pulmonary disease [abstract]. American Journal of Respiratory and Critical Care Medicine 2012;185:A2257. CENTRAL
Watz H, Krippner F, Kirsten A, Magnussen, Vogelmeier C. Indacaterol improves lung hyperinflation and physical activity in patients with moderate chronic obstructive pulmonary disease ‐ a randomized, multicenter, double‐blind, placebo‐controlled study. BMC Pulmonary Medicine 2014;14(1):158. CENTRAL

NCT01380652 {published data only}

NCT01380652. Effects of whole body vibration training on physical activity in Chronic Obstructive Pulmonary Disease (COPD) III/IV patients during a three‐week rehabilitation. clinicaltrials.gov/ct2/show/NCT01380652 (first received 27 June 2011). CENTRAL

NCT01486186 {published data only}

Wang M, Li J, Li S, Wang H, Yu X, Zhang H. Effect of traditional Chinese medicine on outcomes in patients with mild/moderate chronic obstructive pulmonary disease: study protocol for a randomized placebo‐controlled trial. Trials 2012;13:109. CENTRAL

NCT01722370 {published data only}

NCT01722370. Ambulatory oxygen effects on muscles in COPD (OM‐COPD). clinicaltrials.gov/ct2/show/NCT01722370 (first received 6 November 2012). CENTRAL

NCT01854008 {published data only}

Pleguezuelos E, Pérez ME, Guirao L, Samitier B, Costea M, Ortega P, et al. Improving physical activity in patients with COPD with urban walking circuits. Respiratory Medicine 2013;107(12):1948‐56. CENTRAL
Pleguezuelos E, Pérez ME, Guirao L, Samitier B, Costea M, Ortega P, et al. Improving physical activity in patients with severe COPD with urban walking circuits. A randomised trial [abstract]. European Respiratory Society Annual Congress; 2013 September 7‐11; Barcelona. 2013; Vol. 42, issue Suppl 57:302s. CENTRAL

NCT01867970 {published data only}

Van der Weegen S, Verwey R, Spreeuwenberg M, Tange H, Van der Weijden T, De Witte L. It's LiFe! Mobile and web‐based monitoring and feedback tool embedded in primary care increases physical activity: a cluster randomized trial. Journal of Medical Internet Research 2015;17(7):e184. CENTRAL
Verwey R, Van der Weegen S, Spreeuwenberg M, Tange H, Van der Weijden T, De Witte L. A monitoring and feedback tool embedded in a counselling protocol to increase physical activity of patients with COPD or type 2 diabetes in primary care: study protocol of a three‐arm cluster randomised controlled trial. BMC Family Practice 2014;15:93. CENTRAL

NCT01871025 {published data only}

Rodriguez DA, Rodopin A, Guerrero M, Coll R, Huerta A, Soler N, et al. Impact of step exercises as an early intervention during COPD exaverbation [abstract]. European Respiratory Journal 2016;48:PA2061. CENTRAL

NCT02100709 {published data only}

NCT02100709. The effect of NIV on QoL and exercise capacity in a COPD exercise rehabilitation program. clinicaltrials.gov/ct2/show/NCT02100709 (first received 27 March 2014). CENTRAL

NCT02172794 {published data only}

NCT02172794. Tiotropium inhalation capsules and salmeterol inhalation aerosol on muscular efficiency and resting energy expenditure in patients with stable chronic obstructive pulmonary disease. clinicaltrials.gov/ct2/show/NCT02172794 (first received 24 June 2014). CENTRAL

NCT02629965 {published data only}

NCT02629965. Comparing the efficacy of tiotropium + olodaterol fixed dose combination over tiotropium in improvement of lung hyperinflation, exercise capacity and physical activity in Japanese COPD patients. clinicaltrials.gov/ct2/show/NCT02629965 (first received 15 December 2015). CENTRAL

NCT02656667 {published data only}

Vivodtzev I, Debigaré R, Gagnon P, Mainguy V, Saey D, Dubé A, et al. Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. Chest 2012;141(3):716‐25. [DOI: 10.1378/chest.11‐0839; NCT02656667]CENTRAL

NCT03751670 {published data only}

NCT03751670. Pulmonary rehabilitation during acute exacerbations of Chronic Obstructive Pulmonary Disease: a mixed‐methods approach. clinicaltrials.gov/ct2/show/NCT03751670 (first received 23 November 2018). CENTRAL

NL1729 {published data only}

NL1729. Effects of a phyisiotherapeutic exercise programme in patients with a combination of COPD and chronic heart failure: the CHEST‐study. www.trialregister.nl/trial/1729(first received 2009). CENTRAL

Norweg 2006 {published data only}

Norweg AM, Whiteson J, Malady R, Mola A, Rey M. The effectiveness of different combinations of pulmonary rehabilitation program components: a randomized controlled trial. Journal of Cardiopulmonary Rehabilitation 2006;26(2):120‐1. CENTRAL

Nyberg 2017 {published data only}

Nyberg A, Wadell K, Lindgren H, Tistad M. Internet‐based support for self‐management strategies for people with COPD‐protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare. BMJ Open 2017;7(7):e016851. CENTRAL

Paneroni 2016 {published data only}

Paneroni M, Scalvini S, Bernocchi P, Galli T, Baratti D, La Rovere MT, et al. Home telerehabilitation maintenance program for patients affected by COPD and CHF [abstract]. European Respiratory Journal 2016;48(Suppl 60):OA268. CENTRAL

Pasqua 2010 {published data only}

Pasqua F, Biscione G, Crigna G, Auciello L, Cazzola M. Combining triple therapy and pulmonary rehabilitation in patients with advanced COPD: A pilot study. Respiratory Medicine 2010;104(3):412‐7. CENTRAL

Pinnock 2013 {published data only}

Pinnock H, Hanley J, Lewis S, MacNee W, Pagliari C, Van der Pol M, et al. The impact of a telemetric chronic obstructive pulmonary disease monitoring service: Randomised controlled trial with economic evaluation and nested qualitative study. Primary Care Respiratory Journal 2009;18(3):233‐5. CENTRAL

Pitta 2008 {published data only}

Pitta F, Takaki MY, Oliveira NH, Sant'anna TJ, Fontana AD, Kovelis D, et al. Relationship between pulmonary function and physical activity in daily life in patients with COPD. Respiratory Medicine 2008;102(8):1203‐7. CENTRAL

Pomidori 2012 {published data only}

Pomidori L, Contoli M, Mandolesi G, Cogo A. A simple method for home exercise training in patients with chronic obstructive pulmonary disease: One‐year study. Journal of Cardiopulmonary Rehabilitation and Prevention 2012;32(1):53‐7. CENTRAL

Raphael 2014 {published data only}

Raphael Y, Maynard Da Silva K, Bessa EJ, Bartholo TP, Faria AC, Noronha Filho AJ, et al. Brazilian manual of home‐based pulmonary rehabilitation: does it maintain the benefits achieved during the outpatient program? [abstract]. American Journal of Respiratory and Critical Care Medicine 2014;189:A1913. CENTRAL

Ringbaek 2009 {published data only}

Ringbaek T, Broendum E, Martinez G, Thoegersen J, Lange P. Effect of maintenance training after 7‐weeks rehabilitation programme on hospitalisation [abstract]. European Respiratory Society 19th Annual Congress; 2009 Sep 12‐15; Vienna. 2009:P576. CENTRAL

Robbins 2000 {published data only}

Robbins R. More evidence for the short‐term beneficial effects of lung volume reduction surgery. Critical Care 2002;2(1):6379. CENTRAL

Rodriguez‐Trigo 2011 {published data only}

Rodriguez‐Trigo G, Cejudo P, Puy C, Galdiz JB, Bdeir K, Gorostiza A, et al. Long term pulmonary rehabilitation programs for chronic obstructive pulmonary disease (COPD). Two years follow‐up [abstract]. European Respiratory Journal 2011;38(55):655s. CENTRAL

Romagnoli 2005 {published data only}

Romagnoli M, Dell'Orso D, Lubello R, Lucic S, Lugli D, Bellantone T, et al. Repeated pulmonary rehabilitation program (PRP) in severe and disabled COPD patients [abstract]. European Respiratory Journal 2005;26(Supp 49):A542. CENTRAL

Roman 2013 {published data only}

Roman M, Larraz C, Gomez A, Ripoll J, Mir I, Miranda EZ, et al. Efficacy of pulmonary rehabilitation in patients with moderate chronic obstructive pulmonary disease: a randomized controlled trial. BMC Family Practice 2013;14(1):21. CENTRAL

Schacher 2006 {published data only}

Schacher C, Dhein Y, Schoeffski O, Worth H. Comparison of two different exercise programs in chronic obstructive pulmonary disease [abstract]. European Respiratory Journal 2006;28(Suppl 50):555s. CENTRAL

Schönhofer 1997 {published data only}

Schönhofer B, Ardes P, Geibel M, Köhler D, Jones PW. Evaluation of a movement detector to measure daily activity in patients with chronic lung disease. European Respiratory Journal 1997;10(12):2814‐9. CENTRAL

Senthilnathan 2018 {published data only}

Senthilnathan CV, Abinaya P, Rajalaxmi V, Mohan Kumar G, Subramanian SS. Efficacy of physical training program on chronic obstructive pulmonary disease [abstract]. Biomedicine 2018;38(2):240. CENTRAL

Sewell 2005 {published data only}

Sewell L, Singh SJ, Williams JE, Collier R, Morgan MD. Can individualized rehabilitation improve functional independence in elderly patients with COPD?. Chest 2005;128(3):1194‐200. CENTRAL
Sewell L, Singh SJ, Williams JE, Collier R, Morgan MD. Goal directed pulmonary rehabilitation does not significantly improve health status and domestic function. European Respiratory Journal 2001;18(Suppl 33):187s. CENTRAL

Sewell 2010 {published data only}

Sewell L, Singh SJ, Williams JE, Morgan MD. Seasonal variations affect physical activity and pulmonary rehabilitation outcomes. Journal of Cardiopulmonary Rehabilitation and Prevention 2010;30(5):329‐33. CENTRAL

Sirichana 2013 {published data only}

Sirichana W, Moore‐Gillon CE, Patel MH, Taylor M, Storer TW, Cooperr CB. Daily physical activity in COPD: quantification by tri‐axial accelerometry [abstract]. American Journal of Respiratory and Critical Care Medicine 2013;187:A1361. CENTRAL

Soicher 2009 {published data only}

Soicher JE. A longitudinal study of physical activity behaviour in chronic disease: the example of chronic obstructive pulmonary disease [dissertation]. Montreal: McGill University, Montreal, 2009. CENTRAL

Spencer 2012 {published data only}

Spencer L, Mckeough Z, Alison J. Where are they now? Four years after the completion of a maintenance exercise programme in people with COPD [abstract]. Respirology 2012;17(Suppl 1):15. CENTRAL

Steele 2008 {published data only}

Steele BG, Belza B, Cain KC, Coppersmith J, Lakshminarayan S, Howard J, et al. A randomized clinical trial of an activity and exercise adherence intervention in chronic pulmonary disease. Archives of Physical Medicine and Rehabilitation 2008;89(3):404‐12. CENTRAL
Steele BG, Belza B, Coppersmith J, Cain K, Howard J, Lakshminarayan S. Promoting activity and exercise in chronic lung disease: an intervention study [abstract]. American Journal of Respiratory and Critical Care Medicine 2005;191:A2007. CENTRAL

Strijbos 1991 {published data only}

Strijbos JH, Koeter GH, Postma DS, Van Altena R. Reactivation of severe COPD patients. Long term results of a first line and a clinical rehabilitation program. Nederlands Tijdschrift Fysiotherapie 1991;101(4):105‐10. CENTRAL

Sutanto 2018 {published data only}

Sutanto YS, Santi N, Makhabah DN, Aphridasari J, Kusumo H, Reviono R. Pedometer as a tool for quality of life improvement in COPD patients [abstract]. Respirology 2018;23(Suppl 2):244‐5. CENTRAL

TCTR20170214002 {published data only}

TCTR20170214002. The effects of breathing with a positive expiratory pressure on physical activity in patients with Chronic Obstructive Pulmonary Disease. www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=2177 (first received 5 February 2017). CENTRAL

Troosters 2010 {published data only}

Troosters T, Sciurba F, Battaglia S, Langer D, Valluri SR, Martino L, et al. Physical inactivity in patients with COPD, a controlled multi‐center pilot‐study. Respiratory Medicine 2010;104(7):1005‐11. CENTRAL

Troosters 2011 {published data only}

Troosters T, Sutradhar S, Sciurba FC, Klioze SS, Siafakas N, Yunis C, et al. Understanding physical activity in moderate COPD: results from a large, multicenter trial [abstract]. American Journal of Respiratory and Critical Care Medicine 2011;183:A3959. CENTRAL

Tse 2013 {published data only}

Tse HN, Raiteri L, Wong KY, Yee KS, Ng LY, Wai KY, et al. High‐dose N‐acetylcysteine in stable COPD: the 1‐year, double‐blind, randomized, placebo‐controlled HIACE study. Chest 2013;144(1):106‐18. CENTRAL

Turnbull 2013 {published data only}

Turnbull J, McDonnell L, Bott J, Prevost T, Davidson C. Physical exercise and ambulatory oxygen device preference in patients' with exertional hypoxemia: a multicentre RCT [abstract]. European Respiratory Journal 2013;42(Suppl 57):772s. CENTRAL
Turnbull J, McDonnell L, Osman L, Bott J, Prevost T, Davidson AC. Patient activity levels and oxygen device preference: an RCT comparing refillable cylinders (HomefillTM) with usual ambulatory device [abstract]. Thorax 2012;67(Suppl 2):A83. CENTRAL

Turner‐Lawlor 2005 {published data only}

Turner‐Lawlor PJ, Shiels K, Griffiths TL. Randomized controlled trial of an 18 session pulmonary rehabilitation program delivered over 6 or 18 weeks, clinical outcomes [abstract]. American Thoracic Society International Conference; 2005 May 20‐25; San Diego. 2005:C87. CENTRAL

U1111‐1169‐0718 {published data only}

U1111‐1169‐0718. Effect of training in vibrating platform in subjects with Chronic Obstructive Pulmonary Disease. www.ensaiosclinicos.gov.br/rg/RBR‐3kxkzn/ (first received 7 April 2015). CENTRAL

UMIN000001833 {published data only}

Sakai K, Nakayama H, Hokari S, Suzuki R, Takiguchi A, Takada T, et al. The efficacy of the assistant use of short‐acting Beta2 stimulant procaterol on the daily activity in COPD patients: Niigata multicentre study [abstract]. European Respiratory Journal 2011;38:862. CENTRAL

Valenson 2016 {published data only}

Valenson W, Valmonte F, Rodriguez O, Medina E, Lowrey M, Lew S, et al. Perceived barriers to physical activity in patients at high risk for COPD exacerbations. Chest 2016;150(4 Suppl 1):892A. CENTRAL

Voncken‐Brewster 2013 {published data only}

Voncken‐Brewster V, Tange H, De Vries H, Nagykaldi Z, Winkens B, Van der Weijden T. A randomised controlled trial testing a web‐based, computer‐tailored self‐management intervention for people with or at risk for chronic obstructive pulmonary disease: a study protocol. BMC Public Health 2013;13:557. CENTRAL
Voncken‐Brewster V, Tange H, De Vries H, Nagykaldi Z, Winkens B, Van der Weijden T. A randomized controlled trial evaluating the effectiveness of a web‐based, computer‐tailored self‐management intervention for people with or at risk for COPD. International Journal of Chronic Obstructive Pulmonary Disease 2015;10:1061‐73. CENTRAL

Wilson 2015 {published data only}

Wilson AM, Browne P, Olive S, Clark A, Galey P, Dix E, et al. The effects of maintenance schedules following pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomised controlled trial. BMJ Open 2015;5(3):e005921. CENTRAL

Zanini 2002 {published data only}

Zanini A, Giorgetti G, Facchetti C, Mazzucchelli G, Conti S, Lucioni A, et al. Efficacy of a rehabilitation program based on circuit training in COPD subjects: A preliminary report [abstract]. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A738. CENTRAL

ACTRN12615000121561 {published data only}

ACTRN12615000121561. Effect of opioids on outcomes of pulmonary rehabilitation. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367581 (first received 12 January 2015). CENTRAL

ACTRN 12616000360415 {published data only}

Cox NS, McDonald CF, Alison JA, Mahal A, Wootton R, Hill CJ, et al. Telerehabilitation versus traditional centre‐based pulmonary rehabilitation for people with chronic respiratory disease: protocol for a randomised controlled trial. BMC Pulmonary Medicine 2018;18:71. CENTRAL

ACTRN12616001534471 {published data only}

ACTRN12616001534471. A behaviour‐change intervention to reduce sedentary time in people with chronic obstructive pulmonary disease. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371728 (first received 3 Nov 2016). CENTRAL
Cheng SW, Alison JA, Dennis S, Stamatakis E, Spencer LM, McNamara RJ, et al. A behaviour change intervention to reduce sedentary time in people with chronic obstructive pulmonary disease: a protocol for a randomised controlled trial. Journal of Physiotherapy 2017;63:182. CENTRAL

ACTRN12616001586404 {published data only}

ACTRN12616001586404. Effect of a pulmonary rehabilitation program of 8 weeks duration compared to 12 weeks on exercise capacity in people with chronic obstructive pulmonary disease (PuRe Duration): a randomised controlled trial. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371612 (first received 16 November 2016). CENTRAL

ACTRN12617000242325 {published data only}

ACTRN12617000242325. Tai Chi for people with chronic obstructive pulmonary disease (COPD). www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372216 (first received 16 February 2017). CENTRAL

ACTRN12617000499381 {published data only}

ACTRN12617000499381. Non drug interventions to reduce breathlessness in patients with chronic obstructive pulmonary disease (emphysema). www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372467 (first received 6 April 2017). CENTRAL

ACTRN12617000653369 {published data only}

ACTRN12617000653369. Effect of cognitive behaviour therapy on anxiety, depression and breathlessness in patients with chronic obstructive pulmonary disease. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372765 (first received 5 May 2017). CENTRAL

ANZCTR12611000292976 {published data only}

ANZCTR12611000292976. Can changing the way people with chronic lung disease think about breathlessness improve and sustain health outcomes?. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336473 (first received 17 March 2011). CENTRAL
Williams MT, John D, Cafarella P, Frith P. No additional benefit for 6MWT or HADS in combining cognitive behavioural therapy and pulmonary rehabilitation [abstract]. Respirology 2017;22(S2):TO050. CENTRAL
Williams MT, Paquet C, John D, Cafarella P, Frith P. No additional benefits for pulmonary rehabilitation including cognitive behavioural therapy [abstract]. Respirology 2018;23(S1):TO131. CENTRAL

Beekman 2014 {published data only}

Beekman E, Mesters I, Hendriks EJ, Muris JW, Wesseling G, Evers SM, et al. Exacerbations in patients with chronic obstructive pulmonary disease receiving physical therapy: a cohort‐nested randomised controlled trial [protocol]. BMC Pulmonary Medicine 2014;14(1):71. CENTRAL

ChiCTR1800017405 {published data only}

ChiCTR1800017405. Effects of pulmonary rehabilitation prescription on COPD patients. www.chictr.org.cn/showprojen.aspx?proj=28343 (first received 28 July 2018). CENTRAL

DRKS00004931 {published data only}

DRKS00004931. "Medical Vulnerability" Impact of hospital room cooling in vulnerable patients with lung disease during periods of extreme weather (UCaHS). www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004931 (first received 26 April 2013). CENTRAL

DRKS00010777 {published data only}

DRKS00010777. The influence of the maintenance of physical activity on mental health of patients with occupational lung diseases after an inpatient rehabilitation in the BG clinic of Falkenstein. www.dguv.de/ifa/forschung/projektverzeichnis/ff‐fb0227‐2.jsp (first received 15 December 2017). CENTRAL

EUCTR2006‐005534‐20‐GB {published data only}

EUCTR2006‐005534‐20‐GB. Effect of erdosteine on inflammatory and oxidative biomarkers in sputum and exhaled breath in patients with COPD. www.clinicaltrialsregister.eu/ctr‐search/trial/2006‐005534‐20/GB (first received 29 November 2007). CENTRAL

EUCTR2013‐003619‐24‐ES {published data only}

EUCTR2013‐003619‐24‐ES. Benefits of liquid oxygen in chronic obstructive pulmonary disease (COPD) patients without evidence of domiciliary oxygen therapy, presenting desaturation on exertion. www.clinicaltrialsregister.eu/ctr‐search/trial/2013‐003619‐24/ES (first received 13 December 2013). CENTRAL

EUCTR2016‐001238‐89‐ES {published data only}

EUCTR2016‐001238‐89‐ES. Impact of iron replacement in patients with chronic obstructive pulmonary disease. www.clinicaltrialsregister.eu/ctr‐search/trial/2016‐001238‐89/ES (first received 20 April 2016). CENTRAL

EUCTR2016‐001805‐18‐SE {published data only}

EUCTR2016‐001805‐18‐SE. A pilot study to explore safety and efficacy of NBMI treatment compared to placebo in patients with chronic obstructive pulmonary disease. www.clinicaltrialsregister.eu/ctr‐search/trial/2016‐001805‐18/SE (first received 19 May 2016). CENTRAL

Fastenau 2014 {published data only}

Fastenau A. Exercise training and physical activity in patients with mild to moderate COPD in primary care [thesis]. Maastricht: Maastricht University, Maastricht, 2015. CENTRAL
Fastenau A, Muris JW, De Bie RA, Hendriks EJ, Asijee GM, Beekman E, et al. Efficacy of a physical exercise training programme COPD in primary care: study protocol of a randomized controlled trial. BMC Public Health 2014;14:788. CENTRAL
Fastenau A, Van Schayck O, Winkens B, Gosselink R, Muris J. Effectiveness of a physical exercise training programme COPD in primary care: a randomized controlled trial [abstract]. European Respiratory Journal 2015;46:OA3287. CENTRAL

ISRCTN11017699 {published data only}

ISRCTN11017699. Investigation of steroid responsiveness in patients with chronic obstructive pulmonary disease. www.isrctn.com/ISRCTN11017699 (first received 15 November 2016). CENTRAL

ISRCTN13899108 {published data only}

ISRCTN13899108. Can a physical activity programme or pulmonary rehabilitation reduce the risk of heart and circulation disease in people with COPD?. www.isrctn.com/ISRCTN13899108 (first received 5 April 2019). CENTRAL

ISRCTN15949009 {published data only}

ISRCTN15949009. Humidified nasal high flow to improve clinical outcomes following severe exacerbations of chronic obstructive pulmonary disease. www.isrctn.com/ISRCTN15949009 (first received 19 February 2019). CENTRAL

ISRCTN17942821 {published data only}

Bourne CL, Kanabar P, Mitchell K, Schreder S, Houchen‐Wolloff L, Bankart MJ, et al. A self‐management programme of activity coping and education ‐ SPACE for COPD(C) ‐ in primary care: the protocol for a pragmatic trial. BMJ Open 2017;7(7):e014463. CENTRAL
ISRCTN17942821. A self‐management programme of activity coping and education ‐ SPACE FOR COPD ‐ in primary care: a pragmatic trial. www.isrctn.com/ISRCTN17942821?q=&filters=conditionCategory:Respiratory,ageRange:All&sort=relevance&offset=1&totalResults=9&page=1&pageSize=10&searchType=basic‐search (first received 17 November 2014). CENTRAL

ISRCTN19684749 {published data only}

Buttery S, Kemp SV, Shah PL, Waller D, Jordan S, Lee JT, et al. CELEB trial: Comparative effectiveness of lung volume reduction surgery for emphysema and bronchoscopic lung volume reduction with valve placement: a protocol for a randomised controlled trial. BMJ Open 2018;8:e021368. CENTRAL
ISRCTN19684749. CELEB: Lung volume reduction in COPD ‐ surgery vs endobronchial valves. www.isrctn.com/ISRCTN19684749?q=&filters=conditionCategory:Respiratory&sort=&offset=9&totalResults=657&page=1&pageSize=10&searchType=basic‐search (first received 23 May 2016). CENTRAL

ISRCTN27860457 {published data only}

ISRCTN27860457. ON‐EPIC Oral nitrate supplementation to enhance pulmonary rehabilitation in chronic obstructive pulmonary disease. www.isrctn.com/ISRCTN27860457 (first received 22 September 2014). CENTRAL
Pavitt M, Lewis AP, Buttery SC, Fernandez BO, Mikus‐Lelinska M, Feelisch M, et al. Dietary nitrate supplementation increases exercise endurance time in COPD patients using ambulatory oxygen [abstract]. European Respiratory Journal 2018;52(Suppl 62):PA4049. CENTRAL
Pavitt M, Tanner RJ, Lewis AP, Buttery SC, Mehta B, Jefford H, et al. Dietary nitrate supplementation enhances the benefit of pulmonary rehabilitation in people with COPD [abstract]. European Respiratory Journal 2018;52(Suppl 62):PA4045. CENTRAL
Pavitt MJ, Tanner RJ, Lewis AP, Buttery SC, Mehta B, Jefford H, et al. Oral dietary nitrate supplementation to enhance pulmonary rehabilitation in chronic obstructive pulmonary disease: a multi‐centre, double blind, placebo‐controlled, parallel group study [abstract]. Thorax 2018;73(Suppl 4):A3. CENTRAL

ISRCTN45695543 {published data only}

Daynes E, Greening N, Sidiqqui S, Singh SJ. A randomised controlled trial to investigate the use of high‐frequency airway oscillations as training to improve dyspnoea in COPD [protocol]. ERJ Open Research 2019;5:00064‐2019. CENTRAL
ISRCTN45695543. Training to improve dyspnoea. www.isrctn.com/ISRCTN45695543 (first received 15 February 2017). CENTRAL

ISRCTN80279999 {published data only}

ISRCTN80279999. Domiciliary application of non‐invasive positive pressure ventilation with average volume assured pressure support to subjects with chronic obstructive pulmonary disease (COPD) who remain hypercapnic following the application of non‐invasive positive pressure ventilation (NPPV) for an acute exacerbation. www.isrctn.com/ISRCTN80279999 (first received 11 December 2008). CENTRAL

NCT01037387 {published data only}

NCT01037387. Effect of noninvasive ventilation on physical activity and inflammation in COPD patients. clinicaltrials.gov/ct2/show/NCT01037387 (first received 23 December 2009). CENTRAL

NCT01537627 {published data only}

NCT01537627. Long‐term physical training in chronic obstructive pulmonary disease. clinicaltrials.gov/ct2/show/NCT01537627 (first received 23 February 2012). CENTRAL

NCT01539434 {published data only}

NCT01539434. Behavioral intervention to maintain physical capacity and activity in patients with chronic obstructive pulmonary disease (COPD). clinicaltrials.gov/ct2/show/NCT01539434 (first received 27 February 2012). CENTRAL

NCT01783808 {published data only}

NCT01783808. Intervention study to investigate supplemental oxygen in COPD. clinicaltrials.gov/ct2/show/NCT01783808 (first received 5 February 2013). CENTRAL

NCT01905982 {published data only}

NCT01905982. The effect of reflective breathing therapy compared with conventional breathing therapy in patients with chronic obstructive pulmonary disease (COPD) III‐IV; part 2. clinicaltrials.gov/ct2/show/NCT01905982 (first received 23 July 2013). CENTRAL

NCT01998724 {published data only}

Moy ML, Wayne PM, Litrownik D, Beach D, Klings ES, Davis RB, et al. Long‐term exercise after pulmonary rehabilitation (LEAP): design and rationale of a randomized controlled trial of Tai Chi. Contemporary Clinical Trials 2015;45(Part B):458‐67. CENTRAL

NCT02099799 {published data only}

NCT02099799. The effect of physical activity promotion on short and long‐term outcomes in COPD (WEB). clinicaltrials.gov/ct2/show/NCT02099799 (first received 31 March 2014). CENTRAL

NCT02205242 {published data only}

NCT02205242. BACE trial substudy 1 ‐ PROactive substudy. clinicaltrials.gov/ct2/show/NCT02205242 (first received 31 July 2014). CENTRAL

NCT02398643 {published data only}

NCT02398643. Examine the impact of early education on COPD management. clinicaltrials.gov/ct2/show/NCT02398643 (first received 25 March 2015). CENTRAL

NCT02455206 {published data only}

NCT02455206. Counseling during pulmonary rehabilitation. clinicaltrials.gov/ct2/show/NCT02455206 (first received 27 May 2015). CENTRAL
Rausch‐Osthoff AK, Greco N, Schwank A, Beyer S, Gisi D, Scheermesser M, et al. Effect of counselling during pulmonary rehabilitation on self‐determined motivation towards physical activity in people with chronic obstructive pulmonary disease ‐ protocol of a mixed methods study. BMC Pulmonary Medicine 2017;17(1):115. CENTRAL

NCT02471235 {published data only}

Ko FW, Chan K‐P, Tam W, Wong I, Chan TO, Ip A, et al. Short‐course pulmonary rehabilitation and exacerbations and activity of COPD patients over 1 year [abstract]. European Respiratory Journal 2018;52(Suppl 52):PA3353. CENTRAL
NCT02471235. Short‐course out‐patient pulmonary rehabilitation and COPD exacerbations. clinicaltrials.gov/ct2/show/NCT02471235 (first received 15 June 2015). CENTRAL

NCT02478359 {published data only}

Estrada EL, Silva K, Medina E, Desai S, Fan VS, Nguyen HQ. Depression and anxiety are associated with COPD patients' lower confidence for increasing physical activity but not with their motivation [abstract]. American Journal of Respiratory and Critical Care Medicine 2018;197:A7066. CENTRAL
Lee JS, Liu AI, Pounds D, Mahmud F, Flores C, Desai SA, et al. Characteristics of COPD patients who agree to participate in a pragmatic trial of physical activity coaching compared to non‐participants [abstract]. American Journal of Respiratory and Critical Care Medicine 2018;197:A2642. CENTRAL
NCT02478359. Walk on! Physical activity coaching. clinicaltrials.gov/ct2/show/NCT02478359 (first received 23 June 2015). CENTRAL
Nguyen HQ, Bailey A, Coleman KJ, Desai S, Fan VS, Gould MK, et al. Patient‐centered physical activity coaching in COPD (Walk On!): a study protocol for a pragmatic randomized controlled trial. Contemporary Clinical Trials 2016;46:18‐29. CENTRAL
Valenson W, Valmonte F, Rodriguez O, Medina E, Lowrey M, Lew S, et al. Perceived barriers to physical activity in patients at high risk for COPD exacerbations [abstract]. Chest 2016;150(4 Suppl 1):892A. CENTRAL

NCT02557178 {published data only}

NCT02557178. Home‐based health management of COPD patients. clinicaltrials.gov/ct2/show/NCT02557178 (first received 23 September 2015). CENTRAL

NCT02667171 {published data only}

Hansen H, Bieler T, Beyer N, Godtfredsen N, Kallemose T, Frolich A. COPD online‐rehabilitation versus conventional COPD rehabilitation ‐ rationale and design for a multicenter randomized controlled trial study protocol (CORe trial). BMC Pulmonary Medicine 2017;17:140. CENTRAL
NCT02667171. COPD online rehabilitation (CORe) (CORe). clinicaltrials.gov/ct2/show/NCT02667171 (first received 28 January 2016). CENTRAL

NCT02691104 {published data only}

NCT02691104. Use of the SMART COPD physical activity app in pulmonary rehabilitation. clinicaltrials.gov/ct2/show/NCT02691104 (first received 25 February 2016). CENTRAL

NCT02702791 {published data only}

NCT02702791. Sustaining training effects through physical activity (STEP). clinicaltrials.gov/ct2/show/NCT02702791 (first received 9 March 2016). CENTRAL

NCT02707770 {published data only}

NCT02707770. The role of ambulatory oxygen in improving the effectiveness of pulmonary rehabilitation for COPD patients. clinicaltrials.gov/ct2/show/NCT02707770 (first received 14 March 2016). CENTRAL

NCT02720822 {published data only}

Currow D, Watts GJ, Johnson M, McDonald CF, Miners JO, Somogyi AA, et al. on behalf of the Australian National Palliative Care Clinical Studies Collaborative. A pragmatic, phase III, multisite, double‐blind, placebo‐controlled, parallel‐arm, dose increment randomised trial of regular, low‐dose extended‐release morphine for chronic breathlessness: breathlessness, exertion And morphine sulfate (BEAMS) study protocol. BMJ Open 2017;7(7):e018100. CENTRAL
NCT02720822. Breathlessness exertion and morphine sulphate (BEAMS). clinicaltrials.gov/ct2/show/NCT02720822 (first received 28 March 2016). CENTRAL

NCT02864420 {published data only}

Levine DM, Ouchi K, Blanchfield B, Diamond K, Licurse A, Pu CT, et al. Hospital‐level care at home for acutely ill adults: a pilot randomized controlled trial. Journal of General Internal Medicine 2018;33(5):729‐36. CENTRAL
NCT02864420. Hospitalization at home: The acute care home hospital program for adults. clinicaltrials.gov/ct2/show/NCT02864420 (first received 12 August 2016). CENTRAL

NCT02895152 {published data only}

NCT02895152. Activity monitor use in COPD patients undergoing rehabilitation. clinicaltrials.gov/ct2/show/NCT02895152 (first received 9 September 2016). CENTRAL

NCT02917915 {published data only}

NCT02917915. The CaNadian Standardized Pulmonary Rehabilitation Efficacy trial (CoNSPiRE). clinicaltrials.gov/ct2/show/NCT02917915 (first received 28 September 2016). CENTRAL
Selzler AM, Jourdain T, Sedeno M, Wald J, Janaudis‐Ferreira T, Goldstein R, et al. Development of the Canadian standardized pulmonary rehabilitation efficacy trial: a protocol update [abstract]. Canadian Journal of Respiratory Critical Care and Sleep Medicine 2017;1(3):170. CENTRAL

NCT02924870 {published data only}

NCT02924870. Long‐term effect of an health education program on daily physical activity in patients with moderate to very severe chronic obstructive pulmonary disease (EA‐EPOC). clinicaltrials.gov/ct2/show/NCT02924870 (first received 5 October 2016). CENTRAL

NCT02956213 {published data only}

NCT02956213. Indoor air quality and respiratory symptoms in former smokers. clinicaltrials.gov/ct2/show/NCT02956213 (first received 6 November 2016). CENTRAL

NCT02966561 {published data only}

Geidl W, Semrau J, Streber R, Lehbert N, Wingart S, Tallner A, et al. Effects of a brief, pedometer‐based behavioral intervention for individuals with COPD during inpatient pulmonary rehabilitation on 6‐week and 6‐month objectively measured physical activity: study protocol for a randomized controlled trial. Trials 2017;18:396. CENTRAL
NCT02966561. Pedometer‐based behavioural intervention for individuals with COPD to stay active after rehabilitation (STAR). clinicaltrials.gov/ct2/show/NCT02966561 (first received 17 November 2016). CENTRAL

NCT02999685 {published data only}

Benzo RP, Kramer KM, Hoult JP, Anderson PM, Begue IM, Seifert SJ. Development and feasibility of a home pulmonary rehabilitation program with health coaching. Respiratory Care 2018;63(2):131‐40. CENTRAL
NCT02999685. Home‐based health management of chronic obstructive lung Ddsease (COPD) patients. clinicaltrials.gov/ct2/show/NCT02999685 (first received 21 December 2016). CENTRAL

NCT03073954 {published data only}

NCT03073954. Working memory training in COPD patients: the Cogtrain‐Trial. clinicaltrials.gov/ct2/show/NCT03073954 (first received 8 March 2017). CENTRAL

NCT03080662 {published data only}

NCT03080662. Impact of inspiratory muscle training on daily physical activity (INAF). clinicaltrials.gov/ct2/show/NCT03080662 (first received 15 March 2017). CENTRAL

NCT03084874 {published data only}

NCT03084874. Efficacy of a coaching program to promote physical activity and reduce sedentary behavior after a COPD hospitalization. clinicaltrials.gov/ct2/show/NCT03084874 (first received 21 March 2017). CENTRAL

NCT03114241 {published data only}

NCT03114241. Long‐term effects of a 3‐month pedometer‐based program to enhance physical activity in patients with severe COPD. clinicaltrials.gov/ct2/show/NCT03114241 (first received 14 April 2017). CENTRAL

NCT03127878 {published data only}

NCT03127878. Effects of upper‐limb training addition to a conventional ET program on PA level and ADL performance. clinicaltrials.gov/ct2/show/NCT03127878 (first received 25 April 2017). CENTRAL

NCT03201198 {published data only}

NCT03201198. Active for life: chronic obstructive pulmonary disease (ActiveCOPD). clinicaltrials.gov/ct2/show/NCT03201198 (first received 28 June 2017). CENTRAL

NCT03275116 {published data only}

NCT03275116. The effect of twice daily vs. once daily bronchodilation on hyperinflation in COPD patients during 24 hours (BOTH). clinicaltrials.gov/ct2/show/NCT03275116 (first received 7 September 2017). CENTRAL

NCT03280355 {published data only}

NCT03280355. The effects of singing training for patients with chronic obstructive pulmonary disease. clinicaltrials.gov/ct2/show/NCT03280355 (first received 12 September 2017). CENTRAL

NCT03321279 {published data only}

NCT03321279. Social incentives to increase mobility. clinicaltrials.gov/ct2/show/NCT03321279 (first received 25 October 2017). CENTRAL

NCT03359473 {published data only}

NCT03359473. Study to evaluate the safety and efficacy of 13 weeks of the selective androgen receptor modulator (SARM) GSK2881078 in chronic obstructive pulmonary disease. clinicaltrials.gov/ct2/show/NCT03359473 (first received 2 December 2017). CENTRAL

NCT03513068 {published data only}

NCT03513068. Portable oxygen concentrator improvements to physical activity, oxygen usage, and quality of life in chronic obstructive pulmonary disease patients using long‐term oxygen therapy (POC‐STEP). clinicaltrials.gov/ct2/show/NCT03513068 (first received 1 May 2018). CENTRAL

NCT03584269 {published data only}

NCT03584269. Innovation in non invasive ventilation in COPD patients treated by long term oxygen therapy (INOV‐LTOT). clinicaltrials.gov/ct2/show/NCT03584269 (first received 12 July 2018). CENTRAL

NCT03584295 {published data only}

NCT03584295. Early extubation by ECCO2R compared to IMV in patients with severe acute exacerbation of COPD (X‐COPD). clinicaltrials.gov/ct2/show/NCT03584269 (first received 12 July 2018). CENTRAL

NCT03620630 {published data only}

NCT03620630. Clinical efficacy and cost effectiveness of MYCOPD in patients with mild and moderate newly diagnosed COPD (EARLY). clinicaltrials.gov/ct2/show/NCT03620630 (first received 8 August 2018). CENTRAL

NCT03654092 {published data only}

Frei A, Radtke T, Lana KD, Braun J, Müller RM, Puhan MA. Effects of a long‐term home‐based exercise training programme using minimal equipment vs. usual care in COPD patients: a study protocol for two multicentre randomised controlled trials (HOMEX‐1 and HOMEX‐2 trials). BMC Pulmonary Medicine 2019;19:57. CENTRAL

NCT03655028 {published data only}

NCT03655028. Increasing physical activity in COPD through rhythmically enhanced music. clinicaltrials.gov/ct2/show/NCT03655028 (first received 31 August 2018). CENTRAL

NCT03660644 {published data only}

NCT03660644. Physical activity following pulmonary rehabilitation in COPD. clinicaltrials.gov/ct2/show/NCT03660644 (first received 6 September 2018). CENTRAL

NCT03746873 {published data only}

NCT03746873. Increase level of physical activity and decrease use of health care for people with COPD. clinicaltrials.gov/ct2/show/NCT03746873 (first received 20 November 2018). CENTRAL

NCT03749655 {published data only}

NCT03749655. Physical activity promotion added to standard care pulmonary rehabilitation and cognitive behavioural therapy. clinicaltrials.gov/ct2/show/NCT03749655 (first received 21 November 2018). CENTRAL

NCT03750292 {published data only}

NCT03750292. Residential cleaning of indoor air to protect COPD patients (CARE). clinicaltrials.gov/ct2/show/NCT03750292 (first received 23 November 2018). CENTRAL

NCT03793192 {published data only}

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Referencias de otras versiones publicadas de esta revisión

Burge 2017

Burge AT, Cox NS, Abramson MJ, Holland AE. Interventions for promoting physical activity in people with COPD. Cochrane Database of Systematic Reviews 2017, Issue 4. [DOI: 10.1002/14651858.CD012626]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Alison 2019

Methods

DESIGN 2 groups

DATES January 2013 to January 2017

SETTING PR, 7 metropolitan hospitals (Australia)

SAMPLE SIZE ESWT, CRQ "For the physical activity outcome, 82 participants will be sufficient to provide 80% power to detect as significant, at the (two‐sided) 5% level, a minimum of 1845 step difference in the mean steps per day between the groups, assuming SD 2968"

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (post‐bronchodilator FER < 0.7)

  • Smoking history > 10 pack‐years

  • No AECOPD within 4 weeks

  • Oxygen desaturation < 90% (6MWT, room air)

  • "Participants with coexisting cardiac conditions, such as controlled atrial fibrillation and controlled heart failure, will be included to ensure that the sample population is representative and reflective of patients currently referred to PR"

EXCLUSION CRITERIA

  • LTOT

  • Resting PaO2 < 55 mmHg or PaCO2 > 50 mmHg (room air)

  • Supervised exercise training within 12 months

  • Comorbidities that may limit performance during assessments or exercise training (severe cardiovascular, neurological or musculoskeletal conditions)

BASELINE CHARACTERISTICS (TOTAL n = 111)

  • INTERVENTION supplemental oxygen with exercise training (n = 58, completed n = 52)

AGE mean 69 (SD 7) years; SEX 30 (52%) male; FEV1 mean 47 (SD 17)% predicted

  • INTERVENTION sham (air) with exercise training (n = 53, completed n = 45)

AGE mean 69 (SD 8) years; SEX 31 (59%) male; FEV1 mean 45 (SD 16)% predicted

Interventions

DURATION OF INTERVENTION 8 weeks

FOLLOW‐UP 6 months

SUPERVISION yes

COMMON INTERVENTION exercise training

DURATION 8 weeks

SETTING supervised outpatient group

CONTACT 3 sessions a week (minimum 20 sessions)

AEROBIC TRAINING treadmill walking, stationary cycling

  • Initial prescription: 30 minutes (20 minutes walking, 10 minutes cycling), progression: 40 minutes (20 minutes walking, 20 minutes cycling) by week 3

  • Initial intensity (6MWT): walking 80% average speed, cycling 60% peak work rate

STRENGTH TRAINING, OTHER COMPONENTS, EDUCATION nil

INTERVENTION supplemental oxygen, 5 litres a minute from oxygen concentrator

SHAM intranasal air, 5 litres a minute from modified oxygen concentrator

Outcomes

DEVICE SenseWear

  • Wear instructions: 7 days

  • Data inclusion criteria: ≥ 3 days, ≥ 20 hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 8 weeks

  • Follow‐up: 6 months post‐intervention

PRIMARY OUTCOMES

  • Exercise capacity: ESWT

  • HRQOL: CRQ total

SECONDARY OUTCOMES

  • HRQOL: CRQ domains

  • Physical activity: step count, sedentary time (< 1.5 METs), LIPA time (1.5 to < 3), MPA time (3 to < 6), VPA time (≥ 6 METs)

  • Exercise capacity: ISWD

  • Adverse events: reported

  • Adherence: reported

  • Also: PFT, dyspnoea, fidelity

Notes

FUNDING "The study was funded by a National Health and Medical Research Council, Australia, project grant APP1019989. Funding information for this article has been deposited with the Crossref Funder Registry."

CONFLICT OF INTEREST statement provided

CONTACT Jenny Alison [email protected] University of Sydney (Australia)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Sequence generation will be determined using a computerised random number generator"

Allocation concealment (selection bias)

Low risk

Quote: "Allocation concealment will be achieved by the use of a central telephone randomisation system coordinated through the NHMRC Clinical Trials Centre at The University of Sydney"

Blinding of participants (performance bias)

Low risk

Quote: "blinding of participants, therapists and assessors"

Blinding of personnel (performance bias)

Low risk

Quote: "blinding of participants, therapists and assessors"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Quote: "blinding of participants, therapists and assessors"

Blinding of outcome assessment [other] (detection bias)

Low risk

Quote: "blinding of participants, therapists and assessors"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT figure provided

Selective reporting (reporting bias)

Low risk

Registry, published protocol and paper in agreement

Paper additionally reports all CRQ domains, adherence, adverse events and intervention fidelity

Other bias

Low risk

Prospective registration

Altenburg 2015

Methods

DESIGN 2 groups (3 subgroups according to location of recruitment)

  • Primary care (PAC vs. no intervention)

  • Secondary care (PAC vs. no intervention)

  • PAC with PR vs. PR

DATES November 2006 to November 2010

SETTING general practice, outpatient hospital clinics, PR centre (The Netherlands)

SAMPLE SIZE calculation based on step count

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD criteria)

  • Age 40 to 80 years

EXCLUSION CRITERIA

  • Comorbidities that may limit physical activity (severe orthopaedic, neurological disorders, heart failure)

  • AECOPD or respiratory tract infection within 8 weeks

BASELINE CHARACTERISTICS of subgroups (not provided by intervention groups)

  • PRIMARY CARE (n = 48)

AGE median 65 (IQR 58 to 72) years; SEX 32 (66%) male; FEV1 median 78 (IQR 66 to 95)% predicted

  • SECONDARY CARE (n = 46)

AGE median 68 (IQR 61 to 72) years; SEX 34 (74%) male; FEV1 median 58 (IQR 40 to 69)% predicted

  • PR (n = 61)

AGE median 54 (IQR 50 to 63) years; SEX 36 (59%) male; FEV1 median 43 (IQR 28 to 58)% predicted

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP 12 months post‐intervention

SUPERVISION yes

INTERVENTION PAC (in‐person, as in De Blok 2006, Hospes 2009)

INTERFACE 5 individual sessions

ACTIVITY lifestyle physical activity (e.g. walking, cycling, stair‐climbing, gardening)

STEP‐TRACKING pedometer (direct feedback)

RECORD diary: daily step count, other activities (e.g. cycle, swim)

GOALS “Maximal” step count goal, end intervention: set personal “physical activity norm” (between mean and maximal step count) goal

EDUCATION/RESOURCES

NO INTERVENTION "care appropriate to their health status"

SUBGROUP PR

DURATION 9 weeks

SETTING centre‐based outpatient group

CONTACT 3 sessions per week, one to two hours

AEROBIC TRAINING "cycling, walking, swimming & sports"

STRENGTH TRAINING nil

OTHER COMPONENTS "psychological and/or nutritional support as needed"

EDUCATION "educational courses"

Outcomes

DEVICE Digiwalker SW‐2000 (pedometer)

  • Wear instructions: 2 weeks, waking hours

  • Data inclusion criteria: ≥ 5 diary days a week

    • Compendium of physical activities used to calculate metabolic equivalents for cycling, (cardio)fitness and swimming

    • Step equivalent defined as the physical activity with the energy expenditure of 1 step

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks (unclear if pedometer values are from the last week of intervention)

  • Follow‐up: 12 months post‐intervention

PRIMARY OUTCOME

  • Physical activity: step count

SECONDARY OUTCOMES

  • Physical activity: "daily physical activity" (step count, metabolic equivalents)

  • HRQOL: SF36, CCQ, CRQ

  • Exercise capacity: 6MWD

  • Adverse events: as in acknowledgements

  • Adherence: not reported

  • Other: spirometry, anthropometry, fatigue, anxiety and depression, self‐efficacy for physical activity, intrinsic motivation for exercise

Notes

FUNDING "This study was supported by an unrestricted grant from Boehringer Ingelheim B.V. and by the University Medical Centre Groningen"

CONFLICT OF INTEREST statement provided

CONTACT Wytske Altenburg [email protected] University of Groningen (The Netherlands)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomization was computerized"

Allocation concealment (selection bias)

High risk

Quote: "Allocation was open to the researcher, counsellor and patient"

Blinding of participants (performance bias)

High risk

Quote: "Allocation was open to the researcher, counsellor and patient"

Blinding of personnel (performance bias)

High risk

Quote: "Allocation was open to the researcher, counsellor and patient"

Blinding of outcome assessment [objective] (detection bias)

Unclear risk

Physical activity: step count was reported by participants

Blinding of outcome assessment [other] (detection bias)

High risk

Quote: "Allocation was open to the researcher, counsellor and patient"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Participant flow chart provided but not specified by group according to site of recruitment (as data are presented)

N.B. high number of dropouts (45% from the counselling arm of the study) in the pulmonary rehabilitation group

Selective reporting (reporting bias)

High risk

PRIMARY OUTCOMES

Paper: additional outcomes reported

  • step equivalents

  • subgroup analysis introduced in Results section ("excluded patients with a baseline daily steps level > 10000/day, who can be considered to be sufficiently active already"); not described in Methods or registry

Registry: 3 months for intervention group, 6 months for both groups (additional follow‐up time points not reported)

SECONDARY OUTCOMES

Registry: upper limb, lower limb and respiratory muscle strength; COPD‐related costs (not reported)

Paper: SF36 (described in Methods, not reported)

Other bias

Low risk

N/A

Arbillaga‐Etxarri 2018

Methods

DESIGN 2 groups

DATES October 2013 to January 2016

SETTING 33 primary care centres and hospitals from 5 seaside municipalities (Spain)

SAMPLE SIZE calculation based on step count

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (FER ≤ 0.7)

  • Age > 45 years

  • Stable clinical condition (≥ 4 weeks without antibiotics or oral corticosteroids)

EXCLUSION CRITERIA registry

  • Living > 6 months a year outside of included municipalities (registry) OR living < 3 months a year away from home

  • Living a distance > 500 meters to any trail

  • Mental disability (Mini Mental State Examination)

  • Comorbidity that may limit study tests (e.g. lower‐limb amputation)

  • Severe psychiatric disease or comorbidity limiting survival at 1 year

BASELINE CHARACTERISTICS

  • INTERVENTION PAC (Urban Training) (n = 202, ITT n = 132)

AGE mean 69 (SD 9) years SEX 170 (84%) male; FEV1 mean 56 (SD 17)% predicted

  • NO INTERVENTION (n = 205, ITT n = 148)

AGE mean 69 (SD 8) years; SEX 176 (86%) male; FEV1 mean 57 (SD 18)% predicted

Interventions

DURATION OF INTERVENTION 12 months

FOLLOW‐UP no

SUPERVISION no

INTERVENTION PAC (Urban Training)

INTERFACE

  • 1 individual session

  • 4 phone calls

  • Text messages (education/motivation, fortnightly)

  • Supervised walking group (optional, monthly)

ACTIVITY walking (trail of intensity as in baseline dyspnoea and 6MWD)

STEP‐TRACKING pedometer (direct feedback)

RECORD personalised calendar

GOALS

  • ≥ 1 trail a day, ≥ 5 days a week, Borg scale dyspnoea (rating 4 to 6)

  • Increase number of walks and/or intensity (symptoms, motivation)

EDUCATION/RESOURCES

  • Brochure with recommendation to complete MPA ≥ 30 minutes, ≥ 5 days a week

  • Link to project website

  • Dossier of walking trail maps

NO INTERVENTION brochure with recommendation to complete MPA ≥ 30 minutes, ≥ 5 days per week

Outcomes

DEVICE Dynaport MoveMonitor (centre of lower back with an elastic strap)

  • Wear instructions: 7 days

  • Data inclusion criteria: ≥ 3 days, ≥ 8 hours within waking hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 months

PRIMARY OUTCOME

  • Physical activity: step count

SECONDARY OUTCOMES

  • HRQOL: CAT, CCQ

  • Exercise capacity: 6MWD

  • Adherence: reported

  • Adverse events: reported

  • Other: AECOPD leading to hospital or emergency room admission, anthropometry, anxiety and depression, cognitive impairment, physical activity experience, participation in PR

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Judith Garcia‐Aymerich [email protected] ISGlobal, Barcelona (Spain)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "A statistician blinded to study objectives and not involved in any study procedure or analysis created the randomisation sequence using Stata 12.0 (StataCorp, College Station, TX, USA) software"

Allocation concealment (selection bias)

Low risk

Quote: "At the second study visit, a physiotherapist allocated patients to the corresponding group using a secured computer file, where allocations were ordered according to the randomisation sequence and only available one at a time"

Blinding of participants (performance bias)

Unclear risk

Unable to blind participants to intervention BUT

Quote: "Patients were not aware of the existence of the alternative group…"

Quote: "We implemented diverse measures to avoid contamination (i.e., that participants did not receive the intervention to which they were randomised)"

Blinding of personnel (performance bias)

High risk

Quote: "The physiotherapists who administered the intervention and knew the allocated groups"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "outcome examiners and data analysts remained blinded to the allocation"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow chart provided

Selective reporting (reporting bias)

Low risk

As per registry

Other bias

Unclear risk

Original estimated enrolment (July 2013) n = 600; Actual enrolment (April 2016) n = 412

Beeh 2014

Methods

DESIGN cross‐over trial (only pre‐cross‐over data used), 2 groups

DATES November 2011 to June 2012

SETTING 14 sites (Germany, Spain, UK)

SAMPLE SIZE calculation based on endurance time (cycle ergometry)

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD moderate to severe: post‐bronchodilator FEV1 ≥ 30% to < 80% predicted, FER < 0.7)

  • Smoking history (current or former) ≥ 10 pack‐years

  • Age ≥ 40 years

  • Stable clinical condition

  • FRC ≥ 120% predicted

  • "Severity of dyspnoea was not a specific inclusion criterion"

EXCLUSION CRITERIA

  • History of asthma or other clinically‐significant respiratory, cardiovascular or other systemic condition that may affect dyspnoea and exercise

  • Respiratory tract infection or AECOPD within 6 weeks (within 3 months if hospitalisation required)

  • LTOT ≥ 15 hours a day

  • Inability to use the study inhaler

  • Contraindications for either the use of anticholinergic drugs or cardiopulmonary exercise testing

  • Patients who, in the investigator’s opinion, may have needed to start PR during the study and/or patients who started/finished PR within 3 months prior to the screening visit

  • Cycled < 2 minutes or > 20 minutes during initial exercise testing

  • Patients could be discontinued from the study at any time at their own request or in the event of ineligibility, non‐compliance, lack of efficacy, loss to follow‐up (non‐attendance), safety concerns (including moderate or severe AECOPD), or any other reason at the investigator’s discretion.

MEDICATIONS

  • No other long‐acting bronchodilators

  • Discontinued prior to screening: LAMA > 7 days, twice daily LABA > 48 hours, once daily LABA > 7 days

  • Relief medication (salbutamol 100 μg) for symptom control as needed

  • Maintenance therapies permitted if ≥ 4 weeks stable use: oral sustained release theophylline, inhaled corticosteroids, oral/parenteral corticosteroids (prednisone ≤10 mg a day, ≤ 20 mg every other day)

BASELINE CHARACTERISTICS

  • INTERVENTION LAMA (aclidinium bromide) (n = 57)

AGE mean 61 (SD 8) years; SEX 35 (61%) male; FEV1 mean 57 (SD 12)% predicted

  • PLACEBO (n = 55)

AGE mean 59 (SD 8) years SEX 42 (76%) male; FEV1 mean 56 (SD 12)% predicted

Interventions

DURATION OF INTERVENTION 3 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION LAMA (aclidinium bromide, 400 μg) twice daily (09:00, 21:00 ± 1 hour) with a dry powder inhaler (Genuair®/Pressair®)

PLACEBO twice daily (09:00, 21:00 ± 1 hour) with a dry powder inhaler (Genuair®/Pressair®)

Outcomes

DEVICE SenseWear Pro3 (software version not reported)

  • Wear instructions: 7 days (remove for personal hygiene)

  • Data inclusion criteria: ≥ 5 days, ≥ 22 hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 3 weeks

PRIMARY OUTCOME

  • Exercise capacity: endurance time (cycle ergometry)

SECONDARY OUTCOMES

  • Physical activity: step count, MVPA time (> 3 METs), active EE (> 3 METs), PAL (total EE divided by resting EE)

  • HRQOL: not reported

  • Adherence: not reported

  • Adverse events: reported

  • Other: dyspnoea, spirometry, frequency of nocturnal awakenings, relief medication use

Notes

FUNDING "This study was supported by Almirall S.A., Barcelona, Spain, and Forest Laboratories LLC, a subsidiary of Actavis, New York, NY, USA. The study sponsors (Almirall S.A., Barcelona, Spain, and Forest Laboratories LLC, a subsidiary of Actavis, New York, NY, USA) were responsible for the conception and design of the study, collection of the data, and data analysis. The sponsors placed no restrictions on statements made in the final version of the manuscript or on the decision to submit the manuscript for publication."

CONFLICT OF INTEREST statement provided

CONTACT Henrik Watz [email protected] German Center for Lung Research, Grosshansdorf (Germany)

Additional data provided: as in Almirall

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomization was performed according to unique patient identification numbers and a computer‐generated random allocation sequence"

Allocation concealment (selection bias)

Unclear risk

Insufficient information

Blinding of participants (performance bias)

Low risk

Quote: "Patients and investigators were blinded to treatment allocation throughout the study"

Blinding of personnel (performance bias)

Low risk

Quote: "Patients and investigators were blinded to treatment allocation throughout the study"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity, exercise capacity

Blinding of outcome assessment [other] (detection bias)

Low risk

N/A

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

Low risk

Paper: physical activity (additional outcome)

Other bias

Low risk

N/A

Bender 2016

Methods

DESIGN 2 groups

DATES May 2013 to September 2014

SETTING pulmonary outpatient clinics (USA)

SAMPLE SIZE "As this was a pilot study, the study was not powered"

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (pre‐bronchodilator FEV1 ≥ 30 to ≤ 80% predicted, FER < 0.7)

  • Smoking history ≥ 10 pack‐years

  • Age ≥ 40 years

  • ≥ 1 maintenance medication

EXCLUSION CRITERIA

  • "Other significant disease"

  • ≥ 3 AECOPD in previous year (acute worsening of symptoms of COPD requiring new or increased doses of systemic corticosteroids, antibiotics, and/or emergency treatment or hospitalisation)

  • Hospitalisation within 12 weeks

BASELINE CHARACTERISTICS

  • INTERVENTION PAC with pedometer (wellness coaching) (n = 57)

AGE mean 65 (SD 8) years; SEX 25 (44%) male; FEV1 post‐bronchodilator mean 56 (SD 12)% predicted

  • INTERVENTION pedometer (n = 58)

AGE mean 66 (SD 8) years; SEX 23 (40%) male; FEV1 post‐bronchodilator mean 52 (SD 12)% predicted

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION PAC (wellness coaching)

INTERFACE

  • 1 individual session

  • 5 phone calls (fortnightly)

ACTIVITY walking

STEP‐TRACKING pedometer (direct feedback)

RECORD diary: daily step count

GOALS personally meaningful activity goal; increase 15% steps a month

EDUCATION/RESOURCES nil

INTERVENTION pedometer

INTERFACE 5 phone calls (fortnightly, report step count)

ACTIVITY walking

STEP‐TRACKING pedometer (direct feedback)

RECORD Diary: daily step count

GOALS, EDUCATION/RESOURCES nil

Outcomes

DEVICE Omron pedometer

  • Wear instructions:

    • 7 to 10 days pre‐randomisation

    • worn for entire study period

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks (N.B. pedometer values from final week of intervention, data only for "completers")

PRIMARY OUTCOME

  • Physical activity: step count

SECONDARY OUTCOMES

  • HRQOL: SGRQ, CAT

  • Exercise capacity: not assessed

  • Adherence: not reported

  • Adverse events: reported

  • Other: dyspnoea

Notes

FUNDING "This study was funded by a grant from GlaxoSmithKline."

CONFLICT OF INTEREST "DS is an employee of GlaxoSmithKline and holds stock/shares in GlaxoSmithKline. AE, now an employee of PAREXEL International, was an employee of GlaxoSmithKline at the time the study was conducted and holds stock/shares in GlaxoSmithKline. SS was an employee of GlaxoSmithKline at the time the study was conducted and holds stock/shares in GlaxoSmithKline. All other authors have confirmed that they have no conflict of interest related to this manuscript."

CONTACT Bruce Bender [email protected] National Jewish Health, Denver (US)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Randomized" insufficient information

Allocation concealment (selection bias)

Unclear risk

Insufficient information

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Insufficient information

Blinding of outcome assessment [objective] (detection bias)

Unclear risk

Physical activity: step count was reported by participants

Blinding of outcome assessment [other] (detection bias)

Unclear risk

Insufficient information

Incomplete outcome data (attrition bias)
All outcomes

High risk

No participant flow diagram provided

Total number randomised provided; no details re exclusion or attrition

Quote: "Forty‐nine of 57 patients in the Goal group and 50 of the 58 in the Control group completed the study and provided a Week 12 mean steps/day assessment forming the Completer population"

Selective reporting (reporting bias)

High risk

No trial registry

Paper:

  • disease severity subgroups

    • baseline post‐bronchodilator FEV1 < 60% versus ≥ 60% predicted. This cut‐point was adjusted to 50% in post‐hoc analysis.

  • results: intervention cost (not outlined in Methods, components not identified e.g. staff training)

  • results: type of goal and achievement (no description of process to review and document goals in Methods)

Other bias

High risk

  • 2 populations were defined for this study:

    • ITT population included all participants who had been randomised, primary analysis population for summaries of demographic/background and secondary endpoint data.

    • Completer population included all participants in the ITT population who completed the 12‐week intervention period; primary analysis population for the primary endpoint.

  • targeted sample size n = 100; as this was a pilot study, the study was not powered to statistically detect differences in any measure between the groups

  • "The initial visit was followed by a 7‐10 day run‐in during which patients wore an Omron pedometer to establish baseline steps/day. At the second visit, patients were randomized…" unclear if this could be considered a pre‐randomisation intervention that might have an impact on the subsequently randomised intervention

  • No discussion of PR participation

Benzo 2016

Methods

DESIGN 2 groups

DATES September 2010 to July 2016

SETTING 2 hospitals (USA)

SAMPLE SIZE calculation based on readmission rates

Participants

INCLUSION CRITERIA

  • Admitted for AECOPD

  • Smoking history (current or former) > 10 pack‐years

  • Age > 40 years

  • Ability to speak English

  • Access to a telephone

EXCLUSION CRITERIA

  • Any medical conditions that may limit study participation

  • Receiving hospice care

BASELINE CHARACTERISTICS

  • INTERVENTION self‐management (health coaching) with optional PR (n = 108, 12 months n = 106)

AGE mean 68 (SD 9) years; SEX 52 (48%) male; FEV1 mean 41 (SD 17)% predicted

  • INTERVENTION optional PR (n = 107, 12 months n = 106)

AGE mean 68 (SD 9) years; SEX 51 (48%) male; FEV1 mean 40 (SD 17)% predicted

Interventions

DURATION OF INTERVENTION 12 months

FOLLOW‐UP no

SUPERVISION no

INTERVENTION self‐management (health coaching)

INTERFACE

  • 1 individual session during admission

  • At least 1 individual in‐person after discharge

  • 12 phone calls

ACTIVITY Stamina InMotion Elliptical Trainer (provided)

STEP‐TRACKING, RECORD nil

GOALS 20 minutes a day (intensity not prescribed)

EDUCATION/RESOURCES

  • Written emergency plan

  • Living a Healthy Life with Chronic Conditions book

  • Instructed on 3 simple upper‐limb exercises and slow pursed‐lip breathing

OPTIONAL PR "Referred for conventional PR" care according to GOLD guidelines

Outcomes

DEVICE Sensewear armband (model and software version not reported)

  • Wear instructions, data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 6 months

  • End intervention: 12 months

PRIMARY OUTCOME

  • Other: rate of COPD‐related rehospitalisation

SECONDARY OUTCOMES

  • Physical activity: step count, sedentary time (< 2 METs), LIPA time (2 to 4 METs), time in moderate‐intensity physical activity (4 to 6 METs), time in vigorous‐intensity physical activity (> 6 METs), PAL (not defined), resting metabolic rate, total EE

  • HRQOL: CRQ

  • Exercise capacity: not assessed

  • Adherence: reported

  • Adverse events: reported

  • Other: prednisolone/antibiotic use

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Roberto Benzo [email protected] Mayo Clinic, Minnesota (US)

Additional information requested

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "We randomly assigned subjects using an online, computer‐generated, simple binomial randomization program to one of the two groups, stratified by center"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL: not specified

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

CONSORT diagram provided

3 people died but full count in the analysis?

Quote: "Patients with missing or unknown outcomes were excluded from this analysis… Intent‐to‐treat analyses were also run to account for the missing values (almost none for the primary outcome). Patients with missing values were considered to have died or to have had COPD hospitalisation in these analyses. Because there were very few missing values and results from intent‐to‐treat analyses were similar to the original analyses, no imputations were done."

Selective reporting (reporting bias)

High risk

Discrepancy with study dates

  • September 2010 to August 2014 (paper) study dates

  • November 2015 (registry) primary outcome changed

  • July 2016 (registry) final data collection date for primary outcome measure

PRIMARY OUTCOME

  • Registry: composite outcome (COPD‐related hospitalisations or death) (not reported)

SECONDARY OUTCOMES

  • Registry: self‐efficacy for physical activity and disease management (not reported)

  • Registry: physical activity level and active energy expenditure; Paper: step count and time in at least moderate‐intensity physical activity

  • Paper: days in hospital, use of antibiotic/prednisone combination (written action plan), confirmed AECOPD, fidelity (additional outcomes reported)

N.B. selective reporting of CRQ domains

Other bias

Unclear risk

  • Unclear impact of greater post‐admission PR attendance in the intervention group

    • "Attendance at PR visits in the first 3 months after discharge (as part of the patient’s discharge plan, not research) was greater in the intervention group than in the control group"

Blumenthal 2014

Methods

DESIGN 2 groups

DATES January 2009 to May 2013

SETTING Duke University Medical Center and Ohio State University (USA)

SAMPLE SIZE "based on two primary outcomes: (1) combined death and hospitalizations/COPD‐related physician visits and (2) QoL (mental health and physical functioning)

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (FEV1 25% to 80% predicted, FER < 0.7)

  • Age ≥ 21 years

EXCLUSION CRITERIA

  • Dementia; psychotic features including delusions or hallucinations; acute suicide or homicide risk

  • Other illness (e.g., cancer) that is likely to cause death within 3 years

  • Unstable angina, congestive heart failure stage III to IV by NYHA classification

  • Active involvement in PR or formal exercise program

BASELINE CHARACTERISTICS

  • INTERVENTION self‐management (coping skills training) (n = 162)

AGE mean 66 (SD 8) years; SEX 101 (62%) male; FEV1 mean 45 (SD 17)% predicted

  • INTERVENTION education and symptom monitoring (n = 164)

AGE mean 67 (SD 9) years; SEX 98 (60%) male; FEV1 mean 46 (SD 17)% predicted

Interventions

DURATION OF INTERVENTION 16 weeks

FOLLOW‐UP annual follow‐up intervals for up to 4 years

SUPERVISION no

INTERVENTION telephone‐based enhanced coping‐skills training (CST)

SETTING home‐based

CONTACT telephone calls

Weeks 1 to 12: 1 session a week, 30 minutes

Weeks 13 and 14: 2 bi‐weekly “booster sessions“

CONTENT coping skills for symptom management

  • teach the participants and caregivers a variety of coping strategies for increasing physical function and reducing emotional distress

  • teach the caregiver how to help the participant acquire and maintain coping skills over the illness trajectory

INTERVENTION usual care plus education and symptom monitoring

SETTING home‐based

CONTACT telephone calls

  • Weeks 1 to 12: 1 session per week, 15 minutes

  • Weeks 13 and 14: 2 bi‐weekly calls

CONTENT assess health status, providing support, COPD education

Outcomes

DEVICE accelerometer (Kenz Lifecorder Plus NL‐216) (hip)

  • Wear instructions: 2 consecutive days

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 16 weeks

  • Follow‐up: 12 months, then annually for 4 years

PRIMARY OUTCOMES

  • HRQOL: mental health and physical functioning (SF36, Pulmonary‐specific Quality of Life Scale, SGRQ)

  • ALSO: combined death and hospitalisations/COPD‐related physician visits

SECONDARY OUTCOME

  • Physical activity: activity time, activity time based on intensity, TEE

  • Exercise capacity: 6MWD

  • ALSO: symptoms, psychosocial measures, coping and social support measures, caregiver and communication assessments, healthcare utilisation costs

Notes

FUNDING “This research was supported by Grant No. HL 065503 from the National Institutes of Health, Bethesda, Maryland”

CONFLICT OF INTEREST not stated

CONTACT James Blumenthal [email protected]

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: “Randomization was performed centrally by computer"

Allocation concealment (selection bias)

Unclear risk

Insufficient information

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Insufficient information

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

Blinded outcomes assessor

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

High risk

  • as for primary outcome; emergency department and physician visits not reported

  • protocol paper lists step count as a physical activity outcome, not reported in results paper

Other bias

Unclear risk

  • prospectively registered

  • discrepancy between intended and recruited participant numbers

PROTOCOL “600 COPD patients and their respective caregivers”

REPORTED ON REGISTRY “746 participants (patients and caregivers) were consented… of these, 326 patients were randomized and participated in the study intervention along with 252 consented participants who acted as a caregiver; in total 578 participants (patients and caregivers) were involved with the study intervention”

Borges 2014

Methods

DESIGN 2 groups

DATES April 2009 to October 2010

SETTING hospital (Brazil)

SAMPLE SIZE calculation based on quadriceps strength

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (FER < 0.7)

  • Age 40 to 85 years

  • Admitted with AECOPD (increase in sputum or cough or worsening of dyspnoea)

  • No hospitalisation within 30 days

  • Absence of musculoskeletal or neurologic conditions that might affect exercise performance

  • No participation in a rehabilitation program within 6 months

  • Absence of any other pulmonary diseases

EXCLUSION CRITERIA

  • Transferred to intensive care unit before the second day of hospitalisation

  • Exhibiting changes in mental status

  • Worsening of hypoxaemia (PaO2 < 40 mmHg room air) or respiratory acidosis (pH < 7.25), or both

  • Hospitalisation time < 5 days

  • Inability to complete any of the evaluations

BASELINE CHARACTERISTICS

  • INTERVENTION exercise training (n = 15)

AGE mean 64 (SD 13) years SEX 8 (53%) male FEV1 mean 42 (SD 14)% predicted

  • NO INTERVENTION (n = 14)

AGE mean 68 (SD 9) years; SEX 10 (71%) male; FEV1 mean 39 (SD 16)% predicted

Interventions

DURATION OF INTERVENTION duration of hospital admission

FOLLOW‐UP 4 weeks

SUPERVISED yes

INTERVENTION exercise training (whole‐body resistance training)

DURATION during admission

SETTING individual sessions

CONTACT began Day 3 until discharge ≥ 3 sessions

AEROBIC TRAINING nil

STRENGTH TRAINING upper and lower limbs (2 sets, 8 repetitions)

  • INITIAL PRESCRIPTION 80% 1RM

  • PROGRESSION symptom perception (Borg scale dyspnoea and fatigue)

OTHER COMPONENTS, EDUCATION nil

N.B. MONITORING

  • Heart rate, oxygen saturation, modified Borg Scale

  • Sessions interrupted: any AE (Borg values ≥ 7), exercise intolerance (heart rate < 70% of predicted maximum, vertigo, syncope, cyanosis)

  • Oxygen administered if SpO2 < 88%, (maintain 92% to 94%)

NO INTERVENTION Normal daily care

  • Chest physiotherapy to remove bronchial secretions

  • Non‐invasive ventilation if needed

  • Verbal instructions to carry on with their normative daily physical activities

  • Medical staff: drug treatment and oxygen therapy (GOLD guidelines)

No exercise programme or recommendation to exercise after hospital discharge

Outcomes

DEVICE Dynaport MoveMonitor

  • Wear instructions:

    • Day 3 and Day 4 of hospitalisation: 12 hours a day (08:00 to 20:00)

    • 1 month post‐discharge: 2 days, excluding weekend

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline: Day 2 of hospitalisation

  • End intervention: hospital discharge

  • Follow‐up: 1 month after hospital discharge

OUTCOMES

  • Physical activity: time walking, standing, sitting, lying

  • HRQOL: SGRQ

  • Exercise capacity: 6MWD

  • Adherence: reported

  • Adverse events: reported

  • Other: spirometry, muscle strength, systemic inflammatory mediators, blood gas levels

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Rodrigo Borges [email protected] University of Sao Paulo, Sao Paulo (Brazil)

Additional data provided: 6MWD; time lying, sitting, standing and walking

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The randomization sequence was computer generated by 1 investigator who was not involved in the study"

Allocation concealment (selection bias)

Low risk

Quote: "allocation was concealed in sequentially numbered, sealed, opaque envelopes"

Blinding of participants (performance bias)

High risk

Unable to be blinded to the intervention

Blinding of personnel (performance bias)

High risk

Quote: "Masking: None (Open Label)"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "evaluations were performed by a blinded evaluator"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Participant flow diagram provided

Randomised n = 46, "completed" n = 29:

Quote: "Despite anticipating a patient attrition rate of 40%, it was necessary to randomise more 4 patients to obtain the calculated sample size"

"we had a 37% loss to follow‐up that can be considered large and probably reflects the patients’ severity because 35% of patients were referred to the ICU. Another reason for the loss during follow up was the high rate of early discharge... In addition, there was a greater loss to follow‐up in the CG because 2 patients died for reasons unrelated to COPD (rupture of aortic aneurysm, sepsis of abdominal origin) and 2 patients refused to attend the hospital 1 month after discharge"

Selective reporting (reporting bias)

High risk

SECONDARY OUTCOMES

Paper: exercise capacity, HRQOL, systemic inflammatory mediators, arterial blood gases (baseline), lung function, length of stay, number of sessions, adherence to sessions (additional outcomes reported)

Other bias

Unclear risk

Retrospectively registered

  • First submitted date: January 2012

  • First posted date: February 2013

  • Start date: April 2009

  • Primary completion (final data collection date for primary outcome measure): December 2009

Participants performed exercises with NIV in 35% of the sessions because of dyspnoea (Borg ≥ 6).

Breyer 2010

Methods

DESIGN 2 groups

DATES March 2006 to March 2007

SETTING (Austria)

SAMPLE SIZE "The present study was the first to investigate the effect of Nordic Walking on the physical activity of COPD patients. Therefore, we were unable to reliably estimate the effect size and variances prior to the study."

Participants

"All patients were retired at time of inclusion or on sick leave"

INCLUSION CRITERIA

  • Diagnosis of COPD

  • Age > 18 years

  • Stable clinical condition (no infection or AECOPD within 12 weeks)

  • Absence of other pathologic conditions that could impair daily physical activities (cerebrovascular diseases, rheumatism, symptomatic osteoporosis)

EXCLUSION CRITERIA

  • Self‐reported AECOPD within 12 weeks

  • Myocardial infarction within 6 months

  • Cardic arrhythmias > Lown IIIb

  • Walking disturbances due to muscle or bone diseases

BASELINE CHARACTERISTICS

  • INTERVENTION exercise training (Nordic walking) with education (n = 30)

AGE mean 62 (SD 9) years; SEX 14 (47%) male; FEV1 mean 48 (SD 19)% predicted

  • INTERVENTION education (n = 30)

AGE mean 59 (SD 8) years; SEX 13 (43%) male; FEV1 mean 47 (SD 16)% predicted

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP 6 months

SUPERVISION yes

INTERVENTION exercise training (Nordic walking)

SETTING "mostly performed outdoors", group

CONTACT 3 sessions a week

AEROBIC TRAINING Nordic walking “bearable dyspnoea, optimal oxygen saturation”

  • INITIAL PRESCRIPTION 75% of baseline maximum heart rate

STRENGTH TRAINING, OTHER COMPONENTS nil

INTERVENTION education

Weekly session: pulmonary pathophysiology, management of breathlessness and exacerbations, clearance of pulmonary secretions, smoking cessation, medication, nutrition

Outcomes

DEVICE DynaPort Activity Monitor (box on a waist belt, leg sensor: left upper leg)

  • Wear instructions: 3 consecutive weekdays, 12 hours after waking

  • Data inclusion criteria: no data were recorded during sleep, weekend or Nordic Walking

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks

  • Follow‐up: 6 months

  • Follow‐up: 9 months

PRIMARY OUTCOME

  • Physical activity: time walking, standing, sitting, walking intensity (NB data extracted from graph, only variable able to be included)

SECONDARY OUTCOMES

  • HRQOL: SF36

  • Exercise capacity: 6MWD

  • Adherence: reported

  • Adverse events: reported

  • Other: dyspnoea, anxiety and depression

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Marie Breyer [email protected] Otto Wagner Hospital, Vienna (Austria)

Additional information requested

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomisation to either the Nordic Walking or the control group was done by a computer‐generated algorithm maintained by SPSS version 15.01"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity: not specified

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT flow diagram provided

Selective reporting (reporting bias)

High risk

PRIMARY OUTCOME

Registry: 6MWD (secondary outcome in paper)

Paper

  • daily physical activity (secondary outcome in registry)

    • time walking, standing, sitting or lying (insufficient data presented for inclusion)

    • walking intensity

  • feasibility of Nordic Walking

SECONDARY OUTCOMES

Paper: SF36 (additional outcome reported)

Other bias

Unclear risk

Retrospectively registered

No information as to whether participants had completed PR or whether they undertook PR during the follow‐up period which may have influenced results.

Burtin 2015

Methods

DESIGN 2 groups

DATES April 2009 to December 2010

SETTING hospital outpatient PR (Belgium)

SAMPLE SIZE calculation based on daily walking time

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD

  • Stable clinical condition

EXCLUSION CRITERIA

  • Diagnoses other than COPD

  • Inability to walk without walking aids or orthopaedic problems impairing daily activities

  • Diagnosed psychiatric or cognitive disorders, progressive neurological or neuromuscular disorders

  • Nickel allergy

  • Hospitalisation within 4 weeks

  • Did not speak the Dutch language

BASELINE CHARACTERISTICS

  • INTERVENTION: PAC (in person) with PR (n = 40)

AGE mean 66 (SD 7) years; SEX 34 (86%) male; FEV1 mean 45 (SD 14)% predicted

  • INTERVENTION: sham with PR (n = 40)

AGE mean 67 (SD 8) years; SEX 32 (79%) male; FEV1 mean 46 (SD 18)% predicted

Interventions

DURATION OF INTERVENTION 6 months

FOLLOW‐UP no

SUPERVISION yes

COMMON INTERVENTION PR

SETTING centre‐based outpatient group

CONTACT 60 sessions (1 week break for evaluation at Month 3)

  • Initial 3 months: 3 sessions a week

  • Final 3 months: 2 sessions a week

  • Increased duration (from 40 to 60 minutes to 60 to 90 minutes)

AEROBIC TRAINING cycling exercise, treadmill walking, stair climbing, arm ergometry

  • Endurance or interval training at moderate‐to‐high intensity, Borg scale dyspnoea and rating of perceived exertion (rating 4 to 6)

  • INITITAL PRESCRIPTION 60% to 70% baseline incremental cycle ergometry maximal workload and 6MWT average speed

STRENGTH TRAINING upper and lower limbs (3 sets, 8 repetitions)

  • INITIAL PRESCRIPTION 70% 1RM

OTHER COMPONENTS individual appointments with other healthcare providers as needed (pulmonologist, psychologist, occupational therapist, dietician, social worker, respiratory nurse)

EDUCATION programme topics: understanding their disease, role of exercise training, dealing with breathlessness, adequate inhaler use, advice on how to adapt daily life activities, psychological aspects, nutritional aspects, social and financial aspects

INTERVENTION PAC (in‐person)

INTERFACE 8 individual sessions

ACTIVITY not specified

STEP‐TRACKING Sensewear Pro armband (no direct feedback)

GOALS feedback provided during sessions

RECORD, EDUCATION/RESOURCES nil

SHAM

INTERFACE 8 individual sessions

STEP‐TRACKING Sensewear Pro armband (no direct feedback)

ACTIVITY, RECORD, GOALS, EDUCATION/RESOURCES nil

Outcomes

DEVICE

Dynaport Minimod1 (McRoberts) (lower back at the height of the second lumbar vertebra): time walking, step count

Sensewear Pro (software version not reported) (upper arm): time in mild (2 to 3.6 METs) physical activity, MVPA (≥ 3.6 METs)

  • wear instructions: 7 days, waking hours (remove for showering or bathing)

  • data inclusion criteria: weekdays, ≥ 8 hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 3 months (1 week break from PR)

  • End intervention: 6 months

PRIMARY OUTCOME

  • Physical activity: time walking, MVPA time (data as per Lahham 2016)

SECONDARY OUTCOMES

  • Physical activity: step count, total time in physical activity (at least 2 METs, data as in Lahham 2016)

  • HRQOL: CRQ

  • Exercise capacity: 6MWD

  • Adherence: not reported

  • Adverse events: not reported

  • Other: spirometry, muscle strength

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Thierry Troosters [email protected] KU Leuven (Belgium)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "This study is a two‐armed randomized controlled trial"
Comment: insufficient information

Allocation concealment (selection bias)

Low risk

Quote: "Group allocation will be performed using sealed opaque envelopes in random block sizes (unknown by the investigators) after stratification for daily number of steps at baseline"

Blinding of participants (performance bias)

Low risk

Comment: Not possible to blind participants to the intervention BUT ‘sham attention’ provided to control group

Quote: "Patients in the control group received a sham attention program. Duration and timing of the individualized sessions were similar to the intervention group, but the general health status of the patient and the progression during training was discussed during the conversations. Intermediate evaluation of physical activity was performed, but no structured feedback was provided"

Blinding of personnel (performance bias)

Low risk

Quote: "The multidisciplinary team providing pulmonary rehabilitation was also blinded to group allocation"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "all tests were performed by experienced health professionals that were blinded to group allocation"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

High risk

SECONDARY OUTCOMES

  • Protocol: "Measurements will be done before, after 3 and 6 months of rehabilitation and 6 and 12 months after terminating the program"; Paper: results only presented for 3 and 6 months

  • Protocol: handgrip force, maximal exercise capacity, endurance exercise capacity, Modified Pulmonary Functional Status and Dyspnea Questionnaire, self efficacy for walking, anxiety and depression (not reported)

  • Paper: "Baseline physical (in)activity (based on median split of 33 minutes of walking per day) was added to the model to compare changes in physical activity between inactive and active patients" (additional)

Other bias

Unclear risk

  • Retrospectively registered "erroneously done after commencement of inclusion, but before the first patients reached the end of the study, ensuring a prospective power calculation and choice of primary endpoint"

  • "We only performed a per‐protocol analysis. Intention‐to‐treat analysis was not possible as we did not obtain follow‐up data in patients that dropped out from the study"

  • "We did not systematically record adherence to the pulmonary rehabilitation program. Consequently we cannot exclude the possibility that attendance rates were different between study groups. The similar increase in exercise tolerance and health‐related quality of life however suggests that adherence was sufficiently high in both groups"

Casaburi 2012

Methods

DESIGN 2 groups

DATES not reported

SETTING 5 sites of the COPD Clinical Research Network (USA)

SAMPLE SIZE calculation based on oxygen use

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (FEV1 ≤ 60% predicted, FER ≤ 0.65)

  • Age ≥ 40 years

  • No AECOPD within 4 weeks

  • PaO2 < 60 torr (room air)

  • LTOT ≥ 6 months (no ambulatory supply or E‐cylinder source)

EXCLUSION CRITERIA

  • Uncontrolled angina

  • Heart failure, orthopaedic, neurologic or cognitive impairments that would limit ambulation

  • PR within 3 months

  • Current smokers

  • Unable to maintain SpO2 ≥ 92% (4 litres a minute of continuous nasal cannula oxygen flow at rest, oxygen conserver setting 6 during exercise)

BASELINE CHARACTERISTICS

  • INTERVENTION supplemental oxygen (lightweight ambulatory) (n = 11)

AGE mean 67 (SD 8) years; SEX 6 (55%) male; FEV1 mean 37 (SD 13)% predicted

  • INTERVENTION supplemental oxygen (E‐cylinder) (n = 11)

AGE mean 67 (SD 10) years SEX 8 (73%) male; FEV1 mean 30 (SD 8)% predicted

Interventions

DURATION OF INTERVENTION 6 months

FOLLOW‐UP no

SUPERVISION no

COMMON INTERVENTION

clinical co‐ordinator: education session focused on increasing LTOT understanding and encouraging ambulation

instructed to use supplemental oxygen 24 hours a day

INTERVENTION supplemental oxygen (lightweight ambulatory)

INTERVENTION supplemental oxygen (E‐cylinder)

Outcomes

DEVICE RT3 (tri‐axial accelerometer) (waist belt)

  • Wear instructions, data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Oxygen use: monitored continuously for 6 months

  • Physical activity:

    • Baseline: 2 weeks (E‐cylinders as ambulatory supply)

    • 3 weeks before Month 3

    • 3 weeks before Month 6

PRIMARY OUTCOME

  • Adherence: oxygen use

SECONDARY OUTCOMES

  • Physical activity: vector magnitude units

  • HRQOL: not assessed

  • Exercise capacity: not assessed

  • Adherence: reported

  • Adverse events: reported

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Richard Casaburi [email protected] Harbor‐UCLA Medical Center, California (USA)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Patients were then randomized (stratified by enrollment site) to either continued E‐cylinder use or lightweight device use" Comment: insufficient information

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Quote: "Masking: None (Open Label)"

Blinding of personnel (performance bias)

High risk

Quote: "Masking: None (Open Label)"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

N/A

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow chart provided

Selective reporting (reporting bias)

Unclear risk

PRIMARY OUTCOME

Paper: average oxygen use per hour, variability in oxygen use pattern over the course of the day (additional outcomes reported)

SECONDARY OUTCOMES

Registry: spirometry (Month 3, Month 6), haemoglobin level, functional exercise capacity, body weight, health status, ambulatory status, survival, number of exacerbations, physician office visits, hospitalisations, exercise endurance (not reported)

Other bias

Unclear risk

  • Study start March 2005

    • May 2006 first posted on registry

    • June 2006 final data collection date for primary outcome measure

    • 2012 paper published

    • July 2016 amended trial registry

  • "After 9 months of recruitment, only 22 patients had been randomized (target was 100), largely because most LTOT patients in our University‐affiliated centers were already utilizing lightweight devices and/or were not sufficiently hypoxemic at rest. Accordingly, the Data Safety and Monitoring Board stopped further recruitment but allowed randomized patients to complete their participation"

Chaplin 2017

Methods

DESIGN 2 groups

DATES May 2013 to July 2015

SETTING PR at university hospitals, primary care and rehabilitation services (UK)

SAMPLE SIZE "The study will aim to recruit as many suitable patients as are referred to the PR service within the operational phase. One of the main objectives of this feasibility study is to provide data on recruitment and to enable an accurate estimation of sample size for a planned RCT. Based on calculations from previous studies carried out in the PR service, we anticipate a recruitment rate of around 100 patients during our operational phase. This feasibility study will enable us to estimate the required sample size for the subsequent RCT based on a realistic recruitment strategy."

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (post‐bronchilator FEV1 < 80% predicted, FER < 0.7)

  • Age ≥18 years

  • MRC dyspnoea scale (grade 2 to 5)

  • Internet access: ability to navigate websites or regular use of email

  • Able to read and write in English

EXCLUSION CRITERIA

  • Unable to participate in exercise due to other comorbidities

  • PR within 12 months

BASELINE CHARACTERISTICS

  • INTERVENTION web‐based PR (n = 51, completed n = 22)

AGE mean 66 (SD 10) years; SEX 38 (75%) male; FEV1 mean 59 (SD 29)% predicted

  • INTERVENTION centre‐based PR (n = 52, completed n = 40)

AGE mean 66 (SD 8) years SEX 33 (64%) male FEV1 mean 55 (SD 21)% predicted

Interventions

DURATION OF INTERVENTION web‐based: predicted to be 6 to 7 weeks, mean 11 weeks observed; centre‐based: 7 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION web‐based PR

SETTING home

CONTACT

  • Initial in‐person session

  • Weekly email or telephone (participant preference)

AEROBIC TRAINING “encouraged to exercise on a daily basis” walking

  • INITIAL PRESCRIPTION 85% baseline ESWT

  • TRAINING INTENSITY visual analogue scale (rating 4 to 7)

STRENGTH TRAINING upper and lower limbs, hand‐held weights

  • TRAINING INTENSITY visual analogue scale (rating 4 to 7)

OTHER COMPONENTS

  • “Progress exercise program appropriately”

  • Weekly exercise target

  • Online exercise diary for home‐based sessions

EDUCATION individualised web page featuring a personalised action plan and educational content based on SPACE for COPD manual, work through content at their own pace

INTERVENTION centre‐based PR

SETTING outpatient group

  • 4 weeks supervised; 3 weeks unsupervised

  • Either hospital or community (community: maximum 12 sessions)

CONTACT twice a week, exercise 60 min, education 60 min

AEROBIC TRAINING

  • endurance‐based walking, Borg scale dyspnoea (rating moderate to severe)

    • INITIAL PRESCRIPTION basline ISWD and ESWT

    • PROGRESSION walking time

  • static cycling (if tolerated), Borg scale dyspnoea and rating of perceived exertion

STRENGTH TRAINING upper and lower limbs, dumbbells, Borg scale rating of perceived exertion (rating 13 – 15)

  • INITIAL PRESCRIPTION 1RM

OTHER COMPONENTS

  • progress “as able and appropriate”

  • unsupervised home exercise programme on days they do not have PR class

  • exercise diary for home‐based sessions

EDUCATION variety of relevant self‐management topics: medication, relaxation skills, chest clearance, breathlessness management and energy conservation

Outcomes

DEVICE Sensewear armband (model and software version not reported)

  • wear instructions: 7 days, 12 hours each day

  • data inclusion criteria: ≥ 4 days, ≥ 8 hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention

PRIMARY OUTCOME

  • Exercise capacity: ISWD

SECONDARY OUTCOMES

  • Physical activity: step count, "20 min bouts of purposeful activity" (data presented from abstract, 2017 publication states "physical activity data to be presented in future publication")

  • HRQOL: CRQ, CAT

  • Exercise capacity: ESWT

  • Adherence: not reported

  • Adverse events: method for assessment outlined in protocol

  • Other: anxiety and depression, self efficacy for pulmonary rehabilitation, COPD knowledge, web usage, uptake and dropout

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Emma Chaplin emma.chaplin@uhl‐tr.nhs.uk University Hospitals Of Leicester NHS Trust, Leicester (UK)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomisation to treatment group allocation will be a 1:1 ratio to either group and will use internet based ‘Sealed Envelope’ randomisation codes where treatment group allocation is sent by automated email to the research physiotherapist"

Allocation concealment (selection bias)

Low risk

Quote: "Randomisation to treatment group allocation will be a 1:1 ratio to either group and will use internet based ‘Sealed Envelope’ randomisation codes where treatment group allocation is sent by automated email to the research physiotherapist"

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "clinical measures... were conducted by a research physiotherapist who was blinded to treatment group allocation"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

High risk

PRIMARY OUTCOME

Registry: ISWD; Paper: only baseline ISWD data reported

N.B. paper: "physical activity data are to be presented in future publications"

Other bias

Unclear risk

  • Query 1. Sample size

REGISTRY 06/05/2015: The following changes were made to the trial record... The target number of participants was changed from 100 to 120 however 100 participants specified in the protocol and 103 people were randomised

  • Query 2. Duration of web‐based intervention

REGISTRY "We anticipate that it will take approximately 6 to 7 weeks to work through the online programme".

PROTOCOL "We anticipate from our work… that it will take approximately 6 weeks to work through the online programme".

PAPER METHODS "It was anticipated from previous work that it would take ∼6– 8 weeks to work through the online programme"

PAPER RESULTS "The average number of weeks to complete the website was 11±4"

  • Query 3. Definition of completion is quite different between groups

Could this have been a reason for higher drop‐out rate? Not mentioned in Discussion

ABSTRACT "Dropout rates were higher in the web‐based programme (57% vs 23%)."

PAPER METHODS "7 weeks (4 weeks supervised; 3 weeks unsupervised)… Patients were classed as a completer if they had reached stage 3 or above of the web programme, achieving 75% of the programme which is standard in clinical practice for those attending classes".

  • Query 4. Timing of assessments

REGISTRY Follow Up Length: 3 months

PAPER METHODS "Clinical measures were performed at baseline and repeated again at the discharge assessment following completion of either rehabilitation programme (usually ∼6–7 weeks after starting the programme)"

  • Query 5. Definition of a ‘serious adverse event’?

PROTOCOL "patients’ ability to exercise safely will be monitored."

PAPER METHODS "Non‐clinical outcomes included a web‐usage audit for the internet‐based programme, recruitment rates, eligibility and patient preference as well as dropout and completion rates in both treatment groups. Any serious adverse events were reported to the sponsor. A serious adverse event was defined as an acute exacerbation of their COPD that resulted in a hospital admission. In order to assess the patients’ ability to exercise safely, an exercise safety quiz was completed online before being able to progress onto stage 2 of the programme which involved exercising. Patients were then monitored online and through the weekly contacts."

Charususin 2018

Methods

DESIGN two groups

DATES February 2012 to October 2016

SETTING hospitals (Belgium, Germany, The Netherlands, Canada)

SAMPLE SIZE calculation based on 6MWD

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD "spirometry‐proven"

  • Referred for outpatient PR

  • Inspiratory muscle weakness (Pimax < 60 cmH2O or < 50% predicted)

EXCLUSION CRITERIA

  • Diagnosed psychiatric or cognitive disorders, progressive neurological or neuromuscular disorders

  • Severe orthopaedic problems having a major impact on daily activities

  • PR within 1 year

BASELINE CHARACTERISTICS

  • INTERVENTION inspiratory muscle training with PR (n = 110, completed n = 89)

AGE mean 66 (SD 8) years; SEX 52 (47%) male; FEV1 mean 40 (SD 15)% predicted

  • INTERVENTION sham with PR (n = 109, completed n = 85)

AGE mean 65 (SD 7) years; SEX 43 (39%) male; FEV1 mean 43 (SD 17)% predicted

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP no

SUPERVISION no

COMMON INTERVENTION PR

SETTING centre‐based outpatient group

CONTACT 3 to 5 sessions a week, 1 hour (20 sessions Germany, 36 sessions other centres)

AEROBIC TRAINING cycling exercise, treadmill walking, stair climbing, arm ergometry

  • Endurance or interval training, Borg scale dyspnoea (rating 4 to 6, "moderate to high intensity")

STRENGTH TRAINING upper and lower limbs, Borg Scale dyspnoea and rating of perceived exertion

  • INITIAL PRESCRIPTION 60% to 70% 1RM

OTHER COMPONENTS inspiratory muscle training as by group allocation

EDUCATION nil

INTERVENTION inspiratory muscle training

Powerbreathe KH1 device ‘resistance training’ at high intensity (≥ 50% Pimax)

21 min: 6 cycles of 30 breaths; cycle: approx 3.5 min of resistive breathing, 1 min rest; 2 cycles, 3 sessions a day

SHAM

Powerbreathe KH1 device ‘endurance training’ at a low training intensity (≤ 10% Pimax)

21 min: 6 cycles of 30 breaths; cycle: approx 3.5 min of resistive breathing, 1 min rest; 3 cycles, 2 sessions a day

Outcomes

DEVICE Dynaport Minimod

  • Wear instructions: 7 days

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 3 months

PRIMARY OUTCOME

  • Exercise capacity: 6MWD

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: CRQ

  • Exercise capacity: peak work rate and endurance time (cycle ergometry)

  • Adherence: PR component not reported

  • Adverse events: not reported

  • Other: spirometry, anxiety and depression, muscle strength, inspiratory muscle endurance

Notes

FUNDING "HaB International (Southam, UK) and McRoberts (The Hague, The Netherlands) provided equipment for testing and training in this study on loan... Disclaimer: None of the sponsors had any role in the preparation of the trial design, patient recruitment, data collection, data analysis, interpretation of the data, approval of the report or the decision to submit this manuscript for publication."

CONFLICT OF INTEREST "AM acknowledges a previous (now expired) beneficial interest in the POWERbreathe inspiratory muscle trainers in the form of a share of royalty income to the University of Birmingham, and a potential share of royalty income to Brunel University. In the past, she has also provided consultancy services to POWERbreathe International, but no longer does so. She is named on two patents relating to POWERbreathe products, including the device used in the present study, as well as being the author of two books on inspiratory muscle training. FM reports research support from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Grifols and Novartis, advisory board participation for Boehringer Ingelheim and GlaxoSmithKline, and speaking engagements for Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Grifols and Novartis."

CONTACT Daniel Langer [email protected] KU Leuven (Belgium)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Group allocation will be performed by simple randomisation using sealed opaque envelopes in random block sizes of four and six (order unknown to investigators)"

Allocation concealment (selection bias)

Low risk

Quote: "Group allocation will be performed by simple randomisation using sealed opaque envelopes in random block sizes of four and six (order unknown to investigators)"

Blinding of participants (performance bias)

Low risk

Quote: "(sham) intervention described to patients as ‘endurance training’ at a low training intensity"

Blinding of personnel (performance bias)

Low risk

Quote: "Physiotherapists providing this intervention will be blinded to group allocation of patients"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity and exercise capacity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL:

Quote: "all tests will be performed by experienced investigators who are blinded to group allocation"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Low risk

Protocol: anxiety and depression (not reported)

Other bias

Unclear risk

Quote: "data were analysed using a modified intention‐to‐treat approach... we did not consider patients who had missing outcome data due to loss to follow‐up in the analysis. Consequently, no imputation for missing data was performed and a so‐called ‘complete/available case analysis’ was performed"

Quote: "Interactions between centres and between‐group post‐treatment differences in PImax, progression of exercise training intensity, endurance cycling time and 6MWD were observed."

Quote: "One of the centres offering a 36 session programme (32% of total inclusions) consistently exceeded between group differences in the centre offering 20 sessions (36% of total inclusions). In other centres offering 36 sessions (32% of total inclusions), between‐group differences in these outcomes were consistently smaller than in the centre offering a lower training volume"

Quote: "The sham intervention... might even have constituted an endurance‐type training stimulus for these patients in addition to the endurance‐type training stimulus provided by the exercise training sessions"

Cruz 2016

Methods

DESIGN 2 groups

DATES April to July 2014

SETTING 3 primary care centres, district hospital (Portugal)

SAMPLE SIZE calculation based on MVPA time

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD criteria)

  • Age ≥ 18 years

  • Stable clinical condition (no hospital admissions or AECOPD within 4 weeks)

EXCLUSION CRITERIA

  • Severe neurologic, musculoskeletal or psychiatric disorders, unstable cardiovascular disease, severe visual impairment

  • PR within 6 months or regular strenuous exercise

BASELINE CHARACTERISTICS

  • INTERVENTION PAC with PR (n = 16)

AGE mean 69 (SD 8) years; SEX 13 (81%) male; FEV1 mean 66 (SD 21)% predicted

  • INTERVENTION PR (n = 16)

AGE mean 64 (SD 8) years; SEX 14 (88%) male; FEV1 mean 68 (SD 20)% predicted

Interventions

DURATION OF INTERVENTION 6 months

FOLLOW‐UP no

SUPERVISION yes

COMMON INTERVENTION PR

SETTING outpatient group

CONTACT 3 sessions a week, 1 hour

AEROBIC TRAINING walking, 20 minutes, modified Borg Scale dyspnoea and fatigue (rating 4 to 6)

  • INITIAL PRESCRIPTION 60% to 80% baseline 6MWT average speed

STRENGTH TRAINING upper and lower limbs, 15 minutes (2 sets, 10 repetitions)

  • INITIAL PRESCRIPTION 50% to 85% 1RM

  • PROGRESSION "based on the two‐for‐two rule"

OTHER COMPONENTS

  • 5 to 10 minutes warm‐up period: range of motion, stretching, low‐intensity aerobic exercises, breathing techniques

  • 5 minutes balance training: static and dynamic exercises, progressive levels of difficulty

EDUCATION one session per week, 90 minutes

  • Psychosocial support

  • Education sessions: information about COPD, promotion of healthy lifestyles, self‐management strategies

INTERVENTION PAC

INTERFACE

  • 12 weeks during pulmonary rehabilitation: weekly individual session

  • 12 weeks following pulmonary rehabilitation: phone calls weekly Month 1, fortnightly Month 2 and Month 3

ACTIVITY walking

STEP‐TRACKING pedometer Yamax Power Walker EX‐510 (direct feedback)

RECORD diary: daily step count, short‐term step count goals

GOALS ≥ 800 steps if previous goal met

EDUCATION/RESOURCES nil

Outcomes

DEVICE AGT3X+ (Actilife v6.10.4)

  • Wear instructions: 4 consecutive weekdays, waking hours (remove for bathing or swimming)

  • Data inclusion criteria: ≥ 8 hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 3 months

  • Follow‐up: 6 months post‐intervention

PRIMARY OUTCOME

  • Physical activity: step count, sedentary time (0 to 99 cpm), MVPA time (≥ 1952 cpm), total time in physical activity (≥ 100 cpm)

SECONDARY OUTCOMES

  • HRQOL: SGRQ

  • Exercise capacity: 6MWD

  • Adherence: reported

  • Adverse events: not reported

  • Also: self efficacy, muscle strength

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Alda Marques [email protected] University of Aveiro, Aveiro (Portugal)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "This was a randomised controlled trial. Patients were randomly assigned…using a computer‐generated schedule in random blocks of two"

Allocation concealment (selection bias)

Low risk

Quote: "One researcher kept the allocation sequence in sealed opaque envelopes, drew the envelopes and scheduled patients"

Blinding of participants (performance bias)

Unclear risk

Quote: "Patients knew about the existence of two groups but not the differences between interventions"

Blinding of personnel (performance bias)

High risk

Quote: "All measures were administrated in a face‐to‐face interview conducted by the same researchers who implemented the intervention. Thus, assessor blinding was not possible"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

High risk

HRQOL and exercise capacity:

Quote: "all measures were administrated in a face‐to‐face interview conducted by the same researchers who implemented the intervention. Thus, assessor blinding was not possible"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

High risk

PRIMARY OUTCOMES

Registry: time spent in different postures (not reported)

SECONDARY OUTCOMES

Registry: patients' perspectives post intervention, change in number and duration of respiratory exacerbations and hospitalisations (not reported)

Paper: upper‐limb isometric muscle strength, behavioural regulations in exercise (additional outcomes)

Other bias

Unclear risk

Both groups underwent 12 weeks of PR between April and July 2014. The intervention group also received an additional 12 weeks of physical activity‐focused behavioural intervention

  • duration of follow‐up

    • April 2014: receive goals for 2 months post‐programme

    • Jan 2015: receive goals for 6 months post‐programme

    • April 2015: receive goals for 3 months post‐programme

  • number of assessments and time points

    • April 2014: baseline, post‐pulmonary rehabilitation, 2 months follow‐up (3 assessments)

    • January 2015: baseline, post‐pulmonary rehabilitation, 3 months follow‐up, 6 months follow‐up (4 assessments)

Curtis 2016

Methods

DESIGN 2 groups

DATES December 2012 to March 2015

SETTING Royal Brompton Hospital, London (UK)

SAMPLE SIZE calculation based on peak workload (incremental cycle ergometry)

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD stages II to IV)

  • MRC dyspnoea scale (score of 2 or 3)

  • Stable clinical condition

  • Referred for PR

EXCLUSION CRITERIA (PAPER)

  • Using ACE inhibitors or angiotensin‐receptor blockers, other reasons to benefit (including ischaemic heart disease, impairment of ventricular function, diabetes mellitus)

  • Renovascular disease or significant renal impairment

  • AECOPD within 1 month

  • PR within 3 months

  • Comorbid factors that either significantly impaired exercise capacity or ability to participate in rehabilitation (musculoskeletal, neurological, aortic valve disease)

  • Hypotension

EXCLUSION CRITERIA (REGISTRY)

  • Permanent pacemaker (contraindication to magnetic stimulation)

  • Use of anticoagulants (contraindication to biopsy)

  • Allergy to ACE‐inhibitors

  • Pregnancy

BASELINE CHARACTERISTICS

  • INTERVENTION ACE inhibitor with PR (n = 31)

AGE mean 66 (SD 10) years; SEX 14 (45%) male; FEV1 mean 48 (SD 23)% predicted

  • INTERVENTION placebo with PR (n = 34)

AGE mean 68 (SD 7) years; SEX 20 (59%) male; FEV1 mean 52 (SD 20)% predicted

Interventions

DURATION OF INTERVENTION AND FOLLOW‐UP 10 weeks (PR 8 weeks)

SUPERVISION no

COMMON INTERVENTION PR

DURATION 8 weeks

SETTING multidisciplinary outpatient group: goal‐setting and progressive approach, continuous reassessment to allow progression as tolerated

CONTACT 3 exercise sessions a week (2 supervised) 1 hour exercise, 1 hour education

AEROBIC TRAINING treadmill and cycle exercise; intensity 60% to 80% predicted VO2 peak

STRENGTH TRAINING upper and lower limb, weights, progression as tolerated

OTHER COMPONENTS 1 unsupervised home‐based exercise session

EDUCATION self‐management topics including exercise, medication use, diet, coping strategies, increasing physical activity, recognising and managing infections

INTERVENTION ACE inhibitor (10 mg enalapril) once daily

Started treatment 1 week before PR

PLACEBO (microcrystalline cellulose) once daily

Started treatment 1 week before PR

Outcomes

DEVICE SenseWear Pro Armband (professional version 7.0) (body of the triceps muscle of right arm)

  • Wear instructions: 7 days (remove for bathing)

  • Data inclusion criteria: 5 days including 2 weekend days

ASSESSMENT TIME POINTS

  • Baseline

  • Within 1 week of PR completion

  • 10 weeks

PRIMARY OUTCOME

  • Exercise capacity: peak work rate (cycle ergometry)

SECONDARY OUTCOMES

  • Physical activity: step count, PAL (TEE / REE)

  • HRQOL: CAT, SGRQ

  • Also: quadriceps maximal volitional contraction force, blood pressure, spirometry, fat‐free mass, mid‐thigh computed tomography scan

Notes

FUNDING "Supported by the Medical Research Council (grant reference MR/J000620/1), which provided the salary for K.J.C. The salary of M.I.P. is partly funded by the National Institute for Health Research (NIHR) Biomedical Research Unit. H.M. is partly funded by the NIHR University College London Hospitals Biomedical Research Centre. W.D.‐C.M. is funded by a NIHR Clinical Scientist Award (CS/7/007), a NIHR Clinical Trials Fellowship (NIHR‐CTF‐01‐12‐04), a Medical Research Council New Investigator Grant (G1002113), and the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for NW London."

CONFLICT OF INTEREST provided

CONTACT Nicholas S Hopkinson [email protected] Imperial College, London (UK)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Patients were randomly allocated… using block randomization and a block size of four. Randomization was performed by Imperial College Trials Unit"

Allocation concealment (selection bias)

Unclear risk

Insufficient information

Blinding of participants (performance bias)

Low risk

Quote: "Both subjects and the assessor were blind to treatment allocation"

Blinding of personnel (performance bias)

Unclear risk

Insufficient information

Blinding of outcome assessment [objective] (detection bias)

Low risk

Quote: "Both subjects and the assessor were blind to treatment allocation"

Blinding of outcome assessment [other] (detection bias)

Low risk

Quote: "Both subjects and the assessor were blind to treatment allocation"Quote:

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT flow diagram provided

Selective reporting (reporting bias)

Unclear risk

6MWD listed as secondary outcome in the registry; not reported in the paper

Other bias

Low risk

Quote: “Analysis was performed on a per protocol basis”

Comment: Prospectively registered

Dal Negro 2012

Methods

DESIGN 2 groups

DATES not reported

SETTING outpatients..."regularly attending our units" (Italy)

SAMPLE SIZE not reported

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (post‐bronchodilator FEV1 < 50% predicted, FER < 0.7, FEV1 reversibility < 12%)

  • Age > 40 years

  • "Never admitted to any PR program"

  • BMI < 23 kg/m2, body weight stable (within 1 kg) for up to 6 months

  • Daily energy ≥ 28 kcal/kg, protein intake ≥ 1 g/kg

EXCLUSION CRITERIA

  • Any mental deterioration severely affecting the adherence to protocol procedures

  • Endocrine disorders

  • Neoplasms

BASELINE CHARACTERISTICS

  • INTERVENTION nutritional supplement (essential amino acids) (n = 44)

AGE mean 75 (SD 5) years; SEX 32 (73%) male; FEV1 mean 0.8 (SD 0.4) litres per second

  • PLACEBO (n = 44)

AGE mean 73 (SD 8) years; SEX 29 (66%) male; FEV1 mean 0.8 (SD 0.2) litres per second

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION essential amino acids supplement, oral mixture (4 grams, Aminotrofic) dose at 10:00 and 17:00

PLACEBO isocaloric undistinguishable dose oral mixture dose at 10:00 and 17:00

Outcomes

DEVICE SenseWear Armband Pro3 (software version not reported) (upper right arm)

  • Wear instructions: 7 days

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 4 weeks

  • End intervention: 12 weeks

PRIMARY/SECONDARY OUTCOMES

  • Physical activity: step count, "corresponding" EE

  • HRQOL: SGRQ

  • Exercise capacity: not assessed

  • Adherence: not reported

  • Adverse events: reported

  • Other: body composition, nutritional intake, muscle strength, muscle metabolism, cognitive function, blood gases

Notes

FUNDING not reported

CONFLICT OF INTEREST statement not provided

CONTACT R Dal Negro [email protected] Federica Boschi federica [email protected] Universita degli Studi di Pavia, Pavia (Italy)

Additional data requested

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Eight‐eight outpatients…were selected from those regularly attending our units and enrolled… randomisation table"

Allocation concealment (selection bias)

Low risk

Quote: "investigators were blinded to the randomisation table, the code assignments…as subjects were enrolled, they were assigned a progressive number"

Blinding of participants (performance bias)

Low risk

Quote: "indistinguishable dose of placebo"

Blinding of personnel (performance bias)

Unclear risk

Quote: "double‐blind… investigators were blinded to…the procedure"

Comment: not clear if this refers to personnel or outcome assessors

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL: Quote: "double‐blind… investigators were blinded to…the procedure"

Comment: not clear if this refers to personnel or outcome assessors

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Participant flow diagram provided

Selective reporting (reporting bias)

High risk

No trial registry; results presented as in Methods

Unclear whether some results represent change from baseline or post‐intervention values

Other bias

Unclear risk

Unclear relationship with other publication (Dal Negro 2010)

De Blok 2006

Methods

DESIGN 2 groups

DATES not reported

SETTING PR (The Netherlands)

SAMPLE SIZE not reported

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD

  • Age 40 to 85 years

  • Able to read and write in Dutch

EXCLUSION CRITERIA

  • Use a wheelchair

  • Comorbidity interfering with rehabilitation

  • Assigned to rehabilitation modules other than the physical modules

BASELINE CHARACTERISTICS

  • INTERVENTION PAC with PR (n = 10)

AGE mean 66 (SD 10) years; SEX 5 (50%) male; FEV1 mean 52 (SD 22)% predicted

  • INTERVENTION: PR (n = 11)

AGE mean 63 (SD 12) years; SEX 4 (36%) male; FEV1 mean 43 (SD 13)% predicted

Interventions

DURATION OF INTERVENTION 9 weeks

FOLLOW‐UP no

SUPERVISION yes

COMMON INTERVENTION PR

DURATION 9 weeks

SETTING centre‐based outpatient group

CONTACT not stated

EXERCISE TRAINING “according to evidence‐based guidelines”

OTHER COMPONENTS dietary intervention

EDUCATION psycho‐educational modules

INTERVENTION PAC (in‐person, Altenburg 2015, Hospes 2009)

INTERFACE 4 individual sessions

ACTIVITY lifestyle physical activity (e.g. walking, cycling, stair‐climbing, gardening)

STEP‐TRACKING pedometer (direct feedback)

RECORD diary: daily step count, other activities (e.g. cycle, swim)

GOALS “maximal” step‐count goal, end intervention: set personal “physical activity norm” (between mean and maximal step count) goal

EDUCATION/RESOURCES nil

Outcomes

DEVICE Yamax Digi‐Walker SW‐200 (pedometer) (belt or waistband)

  • Wear instructions: waking hours

    • diary: record daily steps, time pedometer on/off

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 9 weeks (pedometer values are from the final week of intervention)

PRIMARY OUTCOME

  • Physical activity: step count

    • 7 days including rehabilitation

    • 4 days without rehabilitation, including 1 weekend

    • 6 days without rehabilitation, including 2 weekends

SECONDARY OUTCOMES

  • HRQOL: SGRQ, RAND‐36

  • Exercise capacity: 2‐minute step test

  • Adherence: PR component not reported

  • Adverse events: not reported

  • Other: spirometry, body composition, functional strength, activities of daily living, fatigue, depression, self‐efficacy

Notes

FUNDING not reported

CONFLICT OF INTEREST statement not provided

CONTACT Mathieu HG de Greef [email protected] University of Groningen (The Netherlands)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Patients who were referred for pulmonary rehabilitation were randomly assigned"

Comment: insufficient information

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention.

Blinding of personnel (performance bias)

Low risk

Quote: "clinical staff…blinded for group assignment"

Blinding of outcome assessment [objective] (detection bias)

Unclear risk

Physical activity: unclear if step count was reported by participants

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity: not specified

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

Unclear risk

No trial registry; results presented as in Methods

Other bias

Low risk

N/A

De Roos 2017

Methods

DESIGN 2 groups

DATES not reported

SETTING primary physiotherapy care centres (The Netherlands)

SAMPLE SIZE calculation based on walking time

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD stage II: FEV1 50% ≤ to < 80% predicted)

  • MRC dyspnoea scale (grade 2 or higher)

  • Stable clinical condition

EXCLUSION CRITERIA

  • Exercise‐restricting non‐COPD‐related complaints (severe cardiac or musculoskeletal diseases)

BASELINE CHARACTERISTICS

  • INTERVENTION exercise training (n = 26, completed n = 21)

AGE mean 69 (SD 10) years; SEX 8 (31%) male; FEV1 mean 68 (SD 8)% predicted

  • NO INTERVENTION (n = 26, completed n = 24)

AGE mean 71 (SD 9) years; SEX 10 (38%) male; FEV1 mean 65 (SD 10)% predicted

Interventions

DURATION OF INTERVENTION 10 weeks

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION exercise training

SETTING group‐based circuit training in primary physiotherapy care centres

CONTACT 2 sessions a week, 1 hour

AEROBIC TRAINING 10 minutes treadmill walking, 10 minutes cycling

STRENGTH TRAINING extremity resistance exercises

OTHER COMPONENTS unsupervised home exercise programme once a week (≥ 30 minutes)

“Emphasis on continuity rather than increasing training intensity and goal setting”

EDUCATION 5 minutes a week: exercise compliance, importance of staying active in daily life

"further details on onset intensity, frequency, duration and progression of the workload are described in Appendix A, see online supplementary material" (not available in online supp)

NO INTERVENTION standard medical care from their general physician, self‐referral consultation in case of worsening symptoms

Outcomes

DEVICE Personal activity monitor (uniaxial accelerometer) (waist) Quantifies amount of motion in vertical plane with EE ≥ 0.8 METs

  • Wear instructions: 7 days, waking hours

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 10 weeks

PRIMARY OUTCOME

  • Physical activity: time in "low" intensity physical activity (1.8 to 3 METs), MVPA time (> 3 METs), total time in physical activity (> 1.8 METs)

SECONDARY OUTCOMES

  • HRQOL: CRQ

  • Exercise capacity: 6MWD

  • Adherence: reported

  • Adverse events: not reported

  • Other: physical activity (subjective), exercise self‐regulatory efficacy

Notes

FUNDING "Eight activity monitors were provided without charge by PAM. PAM had no involvement in the study."

CONFLICT OF INTEREST statement provided

CONTACT Pieter de Roos [email protected], [email protected] Physiotherapy Centre De Oppers (The Netherlands)

Additional information provided: confirmed threshold for MPA

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Allocation was randomised… All possible sequences in permuted blocks of four with two intervention and two control tickets were created and placed at random in sequentially numbered order by an individual not affiliated to the study"

Allocation concealment (selection bias)

Low risk

Quote: "concealed using opaque sealed envelopes… At intake and under the supervision of the physiotherapist in the primary care centre, participants were instructed to open the first envelope"

Blinding of participants (performance bias)

High risk

Unable to blind participants to intervention

Blinding of personnel (performance bias)

Unclear risk

Quote: "there was an inevitable lack of blinding of the physiotherapists"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

High risk

HRQOL and exercise capacity:

Quote: "due to the setting of the research, the outcome assessor was not blinded"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT flow diagram provided

Selective reporting (reporting bias)

Low risk

Results presented as in Methods

Other bias

Unclear risk

Clinical trial registration number NL24766.018.08. but unable to locate

Email confirmation from author that trial was registered as per Dutch regulations, unable to access in English

Demeyer 2017

Methods

DESIGN 2 groups

DATES May 2014 to March 2015

SETTING centres across Europe (Belgium, Greece, UK, Switzerland, The Netherlands)

SAMPLE SIZE calculation based on step count

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD ("physician diagnosis")

  • Smoking history ≥ 10 pack‐years

  • Age > 40 years

  • Not actively participating in PR at inclusion (or did not plan to start)

EXCLUSION CRITERIA

  • Comorbidity limiting a normal activity pattern

  • Primary diagnosis of another respiratory disease

  • Unable to operate a smartphone

BASELINE CHARACTERISTICS

  • INTERVENTION PAC (n = 171, completed n = 159, valid Actigraph data n = 140, valid Dynaport data n = 129)

AGE mean 66 (SD 8) years; SEX 111 (65%) male; FEV1 mean 55 (SD 20)% predicted

  • NO INTERVENTION (n = 172, completed n = 159, valid Actigraph data n = 140, valid Dynaport data n = 132)

AGE mean 67 (SD 8) years; SEX 108 (63%) male; FEV1 mean 57 (SD 21)% predicted

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION physical activity intervention

INTERFACE semi‐automated telecoaching

  • 1 individual in‐person session

  • app

  • weekly group text message

  • phone call prn

ACTIVITY "favourite activities"

STEP‐TRACKING Step counter (Fitbug Air©; direct feedback)

RECORD Fitbug sends step count to app

GOALS

  • Fitbug app: display step count goal, daily feedback

  • ‘PROactive Linkcare’ coaching app: automated goal setting (revised weekly)

EDUCATION/RESOURCES Home exercise booklet

NO INTERVENTION Individual in‐person discussion (5 to 10 minutes at Visit 2)

Standard leaflet explaining the importance of physical activity in COPD and information about physical activity recommendations

Outcomes

DEVICES (waist)

Dynaport MoveMonitor: time walking, walking intensity

Actigraph GT3x (software version not reported): step count, MVPA time

  • wear instructions: 7 days, waking hours

  • data inclusion criteria: ≥ 4 weekdays, ≥ 8 hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks

PRIMARY OUTCOME

  • Physical activity: step count

SECONDARY OUTCOMES

  • Physical activity: MVPA time (≥ 3 METs), time walking, walking intensity, sedentarism (< 5000 steps)

  • HRQOL: CCQ, CAT

  • Exercise capacity: 6MWD

  • Adherence: reported

  • Adverse events: reported

  • Other: spirometry, dyspnoea, muscle strength

Notes

FUNDING "Swisscom AG who provided 30 sim cards and data usage of up to 1 GB per month"

CONFLICT OF INTEREST statement provided

CONTACT Heleen Demeyer [email protected] KU Leuven (Belgium)

Additional information provided: physical activity, HRQOL, exercise capacity

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The random sequence was generated with varying block sizes of 4, 6 or 8 and stratified by centre using a statistical software (STATA V.12.0, StataCorp, College Station, Texas, USA)"

Allocation concealment (selection bias)

Low risk

Quote: "Investigators obtained group allocation using an online system that ensured concealment of random allocation"

Blinding of participants (performance bias)

High risk

Quote: "Neither patients nor investigators were blinded to treatment allocation"

Blinding of personnel (performance bias)

Unclear risk

Quote: "Neither patients nor investigators were blinded to treatment allocation"

Comment: Not clear if this also refers to personnel responsible for implementation

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

High risk

HRQOL and exercise capacity:

Quote: "neither patients nor investigators were blinded to treatment allocation... nevertheless, we do acknowledge the lack of blinding could have minimally influenced the 6MWD results"

Comment: infers 'investigators' refers to assessors

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

High risk

SECONDARY OUTCOMES

Registry: Proportion of patients showing an increase in physical activity > 20%; Paper: "for responder analysis a clinically significant increase in step count was defined as ≥ 1000 steps"

Registry: anxiety and depression, PROactive instrument, satisfaction, compliance (not reported)

Paper: time walking, walking intensity, sedentarism (defined as step count < 5000), AECOPD in the last 12 months (additional outcomes reported)

Other bias

Unclear risk

Sample size calculation

  • Baseline: 253 patients in each arm (total of 506)

  • Mid‐study (revised with updated data): 68 patients are needed in each arm (total of 136)

    • "Recruitment was subsequently stopped because we exceeded the sample size requirements"

Duiverman 2008

Methods

DESIGN 2 groups

DATES November 2004

SETTING 9 rehabilitation centres (The Netherlands)

SAMPLE SIZE calculation based on CRQ

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD stage III or IV, severe; FEV1 < 50% predicted; FER < 0.7)

  • Age 40 to 76 years

  • Stable clinical condition (no AECOPD within 4 weeks, pH 7.35)

  • Hypercapnia at rest (PaCO2 6.0 kPa, room air)

EXCLUSION CRITERIA

  • Cardiac diseases limiting exercise tolerance

  • Neuromuscular or restrictive pulmonary diseases

  • Previous exposure to chronic NIPPV or PR within 18 months

  • Apnoea/hypopnoea index > 10 per hour

BASELINE CHARACTERISTICS

  • INTERVENTION NIPPV with PR (n = 31)

AGE mean 63 (SD 10) years; SEX 18 (58%) male; FEV1 not reported

  • INTERVENTION PR (n = 35)

AGE mean 61 (SD 7) years; SEX 17 (49%) male; FEV1 not reported

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP no

SUPERVISION yes

COMMON INTERVENTION PR

SETTING in‐hospital or outpatient (depending on travel distance to centre)

CONTACT 3 sessions a week, 1 hour

AEROBIC TRAINING Weeks 3 to 12:

  • Cycling 2 sessions a week, 30 minutes interval protocol: alternating 1 minute loaded cycling (140% of initial peak work rate) and 1 minute unloaded cycling

  • Walking 2 sessions per week

    • INITIAL PRESCRIPTION 10 minutes, 80% of baseline 6MWT maximum Borg score

    • PROGRESSION weekly, increase 5 to 10 minutes (up to 30 minutes)

STRENGTH TRAINING upper and lower limbs

OTHER COMPONENTS

  • Daily inspiratory muscle training (30 minutes) interval basis (2 minutes loaded breathing, 1 minute rest)

    • INITIAL PRESCRIPTION threshold resistance 30% PImax

    • PROGRESSION resistance increased 5% to 10% a session (up to 70%)

  • Psychological and/or nutritional support

EDUCATION group sessions: disease, treatment strategies, medication, coping, role of rehabilitation, how to recognise an exacerbation, breathing exercises

INTERVENTION NIPPV (nocturnal, spontaneous/timed mode, nasal or full face mask)

In the hospital within a week after the baseline measurements (before starting PR)

Maximal tolerated inspiratory airway pressure, titrated for optimal correction of nocturnal ABG

In‐hospital practice period until ≥ 6 hours sleep

Outcomes

DEVICE Digiwalker SW‐200 (pedometer)

  • Wear instructions: 10 days, waking hours

    • record the number of steps a day

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks

PRIMARY OUTCOME

  • HRQOL: CRQ

SECONDARY OUTCOME

  • Physical activity: step count

  • HRQOL: Maugeri Respiratory Failure questionnaire, Severe Respiratory Insufficiency questionnaire

  • Exercise capacity: 6MWD, ESWT, peak work rate (cycle ergometry)

  • Adherence: reported

  • Adverse events: reported

  • Other: spirometry, dyspnoea, anxiety and depression, blood gases

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT ML Duiverman [email protected] University Medical Center Groningen (The Netherlands)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomisation was computerised and performed by an independent statistician"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Quote: "Masking: None (Open Label)"

Blinding of personnel (performance bias)

High risk

Quote: "Masking: None (Open Label)"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity and exercise capacity (cycle ergometry)

Blinding of outcome assessment [other] (detection bias)

High risk

HRQOL and exercise capacity (6MWD, ESWT):

Quote: "Masking: None (Open Label)"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Participant flow diagram provided: differential attrition noted

Quote: "In the NIPPV + PR group, seven patients did not complete the study. Five patients could not adapt to the NIPPV (16%), one patient withdrew because of rheumatic complaints and one patient died of progressive respiratory failure due to a COPD exacerbation after 69 days on NIPPV, despite initial blood gas improvements... In the PR group, three patients (9%) did not complete the study because of non‐compliance"

Selective reporting (reporting bias)

High risk

Registry: polysomnography, baseline dyspnoea index, exercise capacity, electromyography, respiratory muscle strength (not reported)

Paper: additional outcomes, step count, HRQOL (Maugeri Respiratory Failure questionnaire, Severe Respiratory Insufficiency questionnaire), anxiety and depression, dyspnoea, arterial blood gases, treatment compliance (additional outcomes)

Other bias

Unclear risk

  • Retrospectively registered on Aug 2005 (study started Nov 2004)

  • 12‐week centre‐based rehabilitation programme

    • could be followed in‐hospital or as an outpatient, depending on travel distance to the centre

    • 39% in NIPPV and PR group, 49% in PR group

  • 72 participants were recruited (power calculation n = 80)

    • "However, recruitment was tedious and, because of financial constraints, we were unable to further extend the inclusion period. This might have influenced our results due to a type II error for false negative outcomes. Effects that were already significant in our study with lower numbers of patients, however, remain valid (type I error unchanged set at 0.05)"

Effing 2011

Methods

DESIGN 2 groups

DATES November 2004 to July 2008

SETTING hospital outpatient pulmonary clinic (The Netherlands)

SAMPLE SIZE calculation based on ISWD

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD criteria: post‐bronchodilator FEV1 25% to 80% predicted)

  • (Ex) smoker

  • Age 40 to 75 years

  • No AECOPD within 4 weeks

  • ≥ 3 AECOPD within 2 years (course of oral corticosteroids and/or antibiotics, or 1 hospitalisation)

  • Able to understand and read Dutch

EXCLUSION CRITERIA

  • Serious other disease with a low survival rate

  • Other diseases influencing bronchial symptoms and/or lung function (cardiac insufficiency, sarcoidosis)

  • Severe psychiatric illness

  • Uncontrolled diabetes mellitus during AECOPD in the past or a hospitalisation for diabetes mellitus within previous 2 years

  • Need for regular oxygen therapy (> 16 hours per day or pO2 < 7.2 kPa)

  • Maintenance therapy with antibiotics

  • Known α1‐antitrypsine deficiency

  • Disorders or progressive disease seriously influencing walking ability (e.g. amputation, paralysis, progressive muscle disease)

BASELINE CHARACTERISTICS

  • INTERVENTION exercise training (COPEactive) with self‐management (n = 77)

AGE mean 63 (SD 8) years; SEX 42 (54%) male; FEV1 mean 50 (SD 14)% predicted

  • INTERVENTION self‐management (n = 76)

AGE mean 64 (SD 8) years; SEX 44 (58%) male; FEV1 mean 51 (SD 17)% predicted

Interventions

DURATION OF INTERVENTION 11 months

FOLLOW‐UP yes

SUPERVISION yes

COMMON INTERVENTION self‐management

4 sessions (2 hours)

follow‐up phone calls

allowed to attend regular, non‐COPEactive physiotherapy sessions if this was prescribed as part of regular care

INTERVENTION exercise training (COPE‐active)

Programme development: problematic activities incorporated (bicycling, walking, climbing stairs, and lifting weights)

SETTING exercise training in private physiotherapy practices, small groups (2 to 3 participants)

CONTACT

  • initial 6 months: 3 sessions a week

  • final 5 months: 2 sessions a week, optional but recommended

AEROBIC TRAINING bicycling, walking, climbing stairs

  • INITIAL PRESCRIPTION baseline incremental maximal cycle ergometry test, sub‐maximal cycle test

  • TRAINING INTENSITY Borg scores for dyspnoea and fatigue

STRENGTH TRAINING upper and lower extremities

  • INITIAL PRESCRIPTION 1RM

OTHER COMPONENTS

  • Unsupervised home exercise programme: walking or cycling, strength exercises (upper and lower extremities), intensity reviewed weekly (detailed protocol)

  • Exercise diary for home‐based sessions

EDUCATION nil

N.B. n = 25 (33%) received non‐standardised physiotherapy

Outcomes

DEVICE Yamax Digi‐Walker SW200 (pedometer)

  • Wear instructions: 7 days

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 7 months

  • End intervention: 12 months

  • Follow‐up: 6 months post‐intervention

  • Follow‐up: 12 months post‐intervention

PRIMARY OUTCOME

  • Exercise capacity: ISWD

SECONDARY OUTCOMES

  • Physical activity: step count

  • Exercise capacity: ESWT

  • HRQOL: CRQ, CCQ

  • Adherence: reported

  • Adverse events: reported

  • Other: body composition, anxiety and depression

Notes

FUNDING not reported

CONFLICT OF INTEREST statement provided

CONTACT Tanja Effing [email protected] University of South Australia, Adelaide (Australia)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Patients were randomised into two study groups, using a minimisation programme"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention.

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity: not specified

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

High risk

PRIMARY OUTCOMES

Registry: duration and severity of exacerbations measured by daily diaries (not reported)

SECONDARY OUTCOMES

Registry: Social Support List, self‐efficacy list, EQ5D (not reported)

Other bias

Unclear risk

  • Retrospectively registered

  • Degree of 'intervention' in the control group (as usual physio care was permitted)

  • "Baseline values were subtracted from follow‐up values to correct for baseline differences"

  • Paper:

    • methods: "We used intention‐to‐treat principles for all analyses"

    • results: "In addition, a per protocol analysis was performed, for which 26 patients (34%) were omitted because of an attendance of less than 70% of the physiotherapeutic sessions"

Egan 2010

Methods

DESIGN 2 groups

DATES June 2007 to July 2010

SETTING PR (UK)

SAMPLE SIZE not reported

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD staging)

  • MRC dyspnoea scale (grade 2 or higher)

  • Referred to PR by respiratory consultant or COPD outreach team member

  • Ability to mobilise independently

  • Motivated to exercise independently

EXCLUSION CRITERIA

  • No evidence of COPD on spirometry

  • AECOPD within 4 to 6 weeks

  • Evidence of ischaemic heart disease/acute changes on ECG

  • Uncontrolled hypertension

  • Insulin‐dependent diabetes mellitus

  • Inability to exercise independently or musculoskeletal/neurological conditions which would prevent completion of the course

  • Lung cancer

  • Previous PR

BASELINE CHARACTERISTICS not reported

  • INTERVENTION PR (n = 18)

  • NO INTERVENTION (n = 25)

Interventions

DURATION OF INTERVENTION 7 weeks

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION PR

SETTING centre‐based outpatient group

CONTACT 2 sessions a week, 1 hour exercise, 1 hour education

AEROBIC TRAINING exercise bike

  • INITIAL PRESCRIPTION baseline ISWT (60% to 80%)

  • PROGRESSION modified Borg score dyspnoea

STRENGTH TRAINING light dumbbells and body resistance

  • TRAINING INTENSITY modified Borg score dyspnoea (rating 3 to 5)

OTHER COMPONENTS

  • balance and flexibility exercises

  • Unsupervised home exercise programme 3 sessions a week (30 minutes, moderate intensity)

  • Unsupervised home inspiratory muscle training 5 sessions a week

    • INITITAL PRESCRIPTION between 15% to 30% PiMax, 10 to 15 minutes

    • PROGRESSION weekly, maximum 60% PiMax, 30 minutes

EDUCATION

  • Multidisciplinary interactive educational sessions: nature of COPD, role of cigarettes, importance of smoking cessation, symptom recognition, inhaler use and technique, pharmacology, coping strategies, action plans

  • 2 booklets

Outcomes

DEVICE SenseWear Pro (software version 6.0) (right triceps)

  • Wear instructions: 5 consecutive days, 23 hours a day (remove for bathing)

  • Data inclusion criteria: wear time 85% over 5 days

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 7 weeks

PRIMARY OUTCOME

  • Physical activity: step count, time in physical activity

SECONDARY OUTCOMES

  • HRQOL: SGRQ

  • Exercise capacity: ISWD (not in abstract)

  • Adherence: not reported

  • Adverse events: not reported

Notes

FUNDING not reported

CONFLICT OF INTEREST statement provided

CONTACT Richard Costello [email protected] Beaumont Hospital, Dublin (Ireland)

Additional information provided: confirmed methodology as per 2012 publication, results as in abstract (no group comparison in paper)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "prospective single‐blinded randomised controlled study" (abstract)

Quote: "random allocation to parallel assignment"(registry)

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity:

Quote: "assessor blinded"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Total number randomised and group numbers provided; no details re attrition or exclusion

Selective reporting (reporting bias)

Unclear risk

Insufficient information (abstract only)

Other bias

Unclear risk

Only PR group data subsequently published

Felcar 2018

Methods

DESIGN 2 groups

DATES July 2010 to October 2014

SETTING university‐based outpatient clinic (Brazil)

SAMPLE SIZE not reported

Participants

INCLUSION CRITERIA (REGISTRY)

  • Diagnosis of COPD (GOLD criteria)

  • Age ≥ 50 years

  • Stable clinical condition (no AECOPD or infections within 12 weeks)

  • No severe or unstable heart disease

  • No other pathological conditions that could influence the training performance

  • No rehabilitation programmes within 6 months

INCLUSION CRITERIA (PAPER)

  • BMI < 32 kg/m2

  • No regular physical training in the preceding year

  • Absence of severe comorbidities that could prevent implementation (orthopaedic, rheumatological, neurological, cardiovascular)

EXCLUSION CRITERIA (REGISTRY)

  • AECOPD during evaluation period

  • Not understanding or non‐co‐operation with the procedures/methods

  • Option of the participant to leave the study for any reason

  • Presence of vestibular disorders

EXCLUSION CRITERIA (PAPER)

  • High and uncontrolled blood pressure

  • Contraindication for performing the procedures

  • Inability to tolerate hydrotherapy

  • Severe AECOPD

BASELINE CHARACTERISTICS

  • INTERVENTION water‐based exercise training (n = 34, completed n = 20)

AGE mean 69 (SD 9) years; SEX 14 (41%) male; FEV1 mean 48 (SD 17)% predicted

  • INTERVENTION land‐based exercise training (n = 36, completed n = 16)

AGE mean 68 (SD 8) years; SEX 9 (25%) male; FEV1 mean 46 (SD 14)% predicted

Interventions

DURATION OF INTERVENTION AND FOLLOW‐UP 6 months

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION water‐based exercise training

SETTING outpatient group; heated pool (33 oC), 1 metre depth; up to 4 participants

CONTACT 60 sessions, 1 hour

  • initial 3 months: 3 sessions a week

  • final 3 months: 2 sessions a week

AEROBIC TRAINING high‐intensity, individualised training load, revised weekly

  • metronome adjusted for target speed, pace dictated by sound stimulus

  • walking

    • INITIAL PRESCRIPTION 75% baseline 6MWT average speed divided by 3

    • AIM 110%, 16 minutes

  • cycling modified Borg scale dyspnoea (rating 4 to 6)

    • AIM 85% of baseline maximal workload, 16 minutes

STRENGTH TRAINING (3 sets, 8 repetitions)

  • INITIAL PRESCRIPTION 70% 1RM plus 14%

  • PROGRESSION weekly, 3% to 6% increase

  • AIM 121% (detailed protocol)

OTHER COMPONENTS nil

EDUCATION 8 group sessions held every 2 weeks, 15 minutes: disease features and treatment, such as physical training, energy conservation techniques, symptoms, nutrition

INTERVENTION land‐based exercise training

SETTING centre‐based outpatient group

CONTACT 60 sessions, 1 hour

  • First 3 months: 3 sessions a week

  • Second 3 months: 2 sessions a week

AEROBIC TRAINING high‐intensity, individualised training load

  • Walking (30 metre flat corridor)

    • INITIAL PRESCRIPTION 75% baseline 6MWT average speed

  • Cycle

    • INITIAL PRESCRIPTION 60% maximal workload (equation includes 6MWT and fat‐free mass)

STRENGTH TRAINING upper and lower limbs

  • INITIAL PRESCRIPTION 70% 1RM

OTHER COMPONENTS nil

EDUCATION 8 group sessions held every 2 weeks, 15 minutes: disease features and treatment, such as physical training, energy conservation techniques, symptoms, nutrition

Outcomes

DEVICE Power Walker‐PW610: monitor set individually taking into consideration body weight and step length (measured in a 10‐metre walk at usual speed)

  • Wear instructions: 6 days, 12 hours

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 12 weeks

  • End intervention: 6 months

PRIMARY OUTCOME

  • Physical activity: step count, daily EE

SECONDARY OUTCOMES

  • HRQOL: CRQ

  • Exercise capacity: ISWD, 6MWD

  • Adverse events: not reported

  • Adherence: not reported

  • Also: spirometry, dyspnoea, body composition, muscle strength, functional status, anxiety and depression, comorbidities

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Fabio Pitta [email protected] Universidade Estadual de Londrina, Parana (Brazil)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomisation was performed in two stages: generation of numbers (table of random numbers)"

Allocation concealment (selection bias)

Low risk

Quote: "blind allocation (opaque and sealed envelopes)"

Blinding of participants (performance bias)

High risk

Quote: "Due to the characteristics of the intervention, it was not possible to blind participants and therapists who applied the training"

Blinding of personnel (performance bias)

High risk

Quote: "Due to the characteristics of the intervention, it was not possible to blind participants and therapists who applied the training"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "outcome assessors were not informed about the allocation of patients in the respective groups"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Participant flow diagram provided

Selective reporting (reporting bias)

Unclear risk

Registry (Time Frame: 4 years)

SECONDARY OUTCOMES

Registry: static balance, timed up and go test (not reported)

Paper: spirometry, peripheral and respiratory muscle strength, anthropometry, dyspnoea, anxiety and depression (additional outcomes)

Other bias

Unclear risk

Registry

  • Original estimated enrolment (September 2012) n = 60

  • Actual enrolment (April 2018) n = 36

Gamper 2019

Methods

DESIGN 2 groups

DATES screened for inclusion July to December 2016

SETTING Rehabilitation Center, Walenstadtberg (Switzerland)

SAMPLE SIZE "aim to... estimate the required sample size for a RCT"

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD stages III and IV)

  • Inpatients assigned to rehabilitation

  • Able to walk 150 metres, cycle at 25 watts for 30 minutes

  • Read and speak German

EXCLUSION CRITERIA

  • AECOPD during study

  • Uncontrolled arterial hypertension, cardiac insufficiency or limiting musculoskeletal disorders

BASELINE CHARACTERISTICS

  • INTERVENTION exercise training (outdoor walking) (n = 8)

AGE mean 66 (SD 7) years; SEX 5 (63%) male; FEV1 not reported

  • INTERVENTION exercise training (cycle ergometer) (n = 8)

AGE mean 63 (SD 9) years; SEX 5 (63%) male; FEV1 not reported

Interventions

DURATION OF INTERVENTION 3 weeks

FOLLOW‐UP 3 months

SUPERVISION yes

COMMON INTERVENTION exercise training

DURATION 3 weeks

SETTING inpatient (commence Day 3 of admission), supervised

CONTACT 6 sessions a week, 30 minutes

AEROBIC TRAINING voluntary exhaustion, 8 to 12 minutes

  • INITIAL PRESCRIPTION as in mode of training

  • PROGRESSION continuous ramp increase by 5 to 10 Watts

    • 5 minutes warm‐up, cool‐down

    • 20 minutes alternating 1 minute intervals of high‐ (Borg 7/10) and low‐intensity (Borg 3/10)

    • oxygen if SpO2 < 90%

INTERVENTION outdoor walking

  • High‐intensity intervals (HRmax 50% to 70% for GOLD IV, 70% to 80% GOLD III)

  • 4 sessions a week (additional 2 sessions a week of cycle ergometer)

  • all weather conditions, walking aids allowed, oxygen cylinder transported on walker or backpack

  • training path was marked every 50 meters, choice of 2 levels of inclination

  • Due to the higher respiratory demand during walking compared to cycling, 10 more heart beats a minute were calculated

INTERVENTION cycle ergometer

  • High‐intensity intervals (Wmax 50% to 70% for GOLD IV, 70% to 80% GOLD III)

Outcomes

DEVICE Fitbit One (Fitbit Inc., San Francisco, CA, USA)

  • Wear instructions: 5 days, waking hours

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline (no physical activity assessment)

  • End intervention: 3 weeks

  • Follow‐up: 3 months

PRIMARY OUTCOME

  • Also: feasibility of outdoor walking training

  • Adherence: training intensity

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQoL: CRQ

  • Exercise capacity: 6MWD

  • Adherence: reported

  • Adverse events: reported

  • Also: frequency of exacerbation

Notes

FUNDING "This study was financially supported by Valens Clinics".

CONFLICT OF INTEREST "The authors state that they have no financial, consulting or personal relationships to people or organizations that could influence the authors’ work. There are no conflicts of interests".

CONTACT Esther Gamper [email protected] Zurich University of Applied Science, Winterthur (Switzerland)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "concealed block randomization procedure"

Comment: insufficient information

Allocation concealment (selection bias)

Unclear risk

Quote: "concealed block randomization procedure"

Comment: insufficient information

Blinding of participants (performance bias)

High risk

REGISTRY Blinding: Open (masking not used)

Blinding of personnel (performance bias)

High risk

REGISTRY Blinding: Open (masking not used)

Blinding of outcome assessment [objective] (detection bias)

Unclear risk

Insufficient information (?participant diary to self‐report)

Blinding of outcome assessment [other] (detection bias)

Unclear risk

Blinded assessor for 6MWT, otherwise assessor unblinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Low risk

Registry and paper in agreement

Other bias

Unclear risk

Retrospective registration

Goris 2003

Methods

DESIGN 2 groups

DATES not reported

SETTING hospital and pulmonary rehabilitation centre (The Netherlands)

SAMPLE SIZE calculation based on BMI

Participants

INCLUSION CRITERIA

  • BMI ≤ 22 kg/m2 or ≤ 25 kg/m2 in combination with recent weight loss (> 5% of usual body mass)

EXCLUSION CRITERIA

  • Severe cardiovascular disease

  • Gastrointestinal abnormalities

  • Endocrine disease

  • Malignancies

  • Dementia

"None of the patients participated in an outpatient or home‐based PR programme"

BASELINE CHARACTERISTICS

  • INTERVENTION nutritional supplement (n = 11)

AGE mean 61 (SD 12) years; SEX 6 (55%) male; FEV1 mean 40 (SD 13)% predicted

  • NO INTERVENTION (n = 9)

AGE mean 62 (SD 10) years; SEX 6 (67%) male; FEV1 mean 40 (SD 16)% predicted

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION nutritional supplement(energy dense)

3 125 ml Respifor (sip‐feed, Nutricia, The Netherlands) morning, afternoon and evening (daily)

provided 2.38 MJ a day (20% protein, 20% fat, 60% carbohydrate)

NO INTERVENTION nutritional advice from a dietitian on how to increase their energy intake

Outcomes

DEVICE Tracmor (triaxial accelerometer) (belt at the back of the waist)

  • Wear instructions: 7 days, waking hours

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: four weeks

  • End intervention: 12 weeks

PRIMARY OUTCOME

  • Physical activity: PAL (total EE / basal metabolic rate), total EE (formula using Tracmor counts and basal metabolic rate)

  • HRQOL: not assessed

  • Exercise capacity: not assessed

  • Adherence: not reported

  • Adverse events: not reported

  • Other: body composition, food and water intake, water loss

Notes

FUNDING not reported

CONFLICT OF INTEREST statement not provided

CONTACT Marja Vermeeren [email protected] University Hospital Maastricht (The Netherlands)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The patients were then at random assigned (with a randomisation table) to the intervention group or to the control group"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

Unclear risk

Not specified

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity (energy expenditure)

Blinding of outcome assessment [other] (detection bias)

Low risk

N/A

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No participant flow diagram provided

Selective reporting (reporting bias)

Unclear risk

No trial registry; results presented as per methods

Other bias

Unclear risk

Quote: "Depleted COPD patients (n=20) were studied 1 and 3 months after discharge from the university hospital… or from the pulmonary rehabilitation centre"

Comment: participants post‐admission might respond differently to people who have just completed PR

Hartman 2016

Methods

DESIGN cross‐over trial (only pre‐cross‐over data used), 2 groups

DATES May 2011 to May 2013

SETTING hospital (The Netherlands)

SAMPLE SIZE not reported

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (post‐bronchodilator FEV1 < 60% predicted, TLC > 100%, RV > 150%)

  • Stopped smoking for at least 6 months

  • Age > 35 years

  • modified MRC dyspnoea scale (grade 2 or greater)

  • CT scan: heterogeneous emphysema (based on visual assessment), ≥ 60% destruction of the target lobe, intact fissures as assessed on the sagittal reconstructions of a thin slice CT

  • Lobar exclusion during endobronchial valve treatment achieved with study device

EXCLUSION CRITERIA

  • Hypercapnia (PaCO2 > 8 kPa) or hypoxaemia (PaO2 < 6 kPa) (room air)

  • 6MWD < 140 metres

  • Previous lung volume reduction surgery, lung transplantation or lobectomy

  • Antiplatelet agent or anticoagulant therapy

  • Other pulmonary drug studies within 30 days prior to this study

  • Other disease that may compromise survival, interfere with completion of study, follow‐up assessments or adversely affect outcomes

  • Evidence of collateral ventilation as measured with the Chartis system

BASELINE CHARACTERISTICS

  • INTERVENTION endobronchial valve surgery (n = 19)

AGE mean 59 (SD 10) years; SEX 6 (32%) male; FEV1 mean 32 (SD 8)% predicted

  • NO INTERVENTION (n = 24)

AGE mean 59 (SD 8) years; SEX 4 (17%) male; FEV1 mean 30 (SD 7)% predicted

Interventions

DURATION OF INTERVENTION surgery

FOLLOW‐UP 6 months

SUPERVISION yes

INTERVENTION endobronchial valve surgery

Outcomes

DEVICE Dynaport MoveMonitor (around the waist at the lower back)

  • Wear instructions: 7 days (remove showering and swimming)

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • Follow‐up: 6 months

PRIMARY/SECONDARY OUTCOMES

  • Physical activity: step count, time waking, time sitting, time inactive, walking intensity (data from table)

  • HRQOL: SGRQ

  • Exercise capacity: 6MWD

  • Adherence: N/A

  • Adverse events: reported

  • Other: spirometry, dyspnoea, body plethysmography

Notes

FUNDING reported

CONFLICT OF INTEREST "NHT and JH have no conflicts of interest, KK received travel grants and a speakers fee from PulmonX, DJS is a physician advisor to PulmonX, received travel grants and lecture fees for educational and scientific meetings from PulmonX and participates in other clinical trials funded by PulmonX. All authors had complete access to the data, reviewed and approved the manuscript. PulmonX was not involved at any stage during the trial."

CONTACT Jorine Hartman [email protected] University Medical Center Groningen (The Netherlands)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "A randomized controlled crossover trial"

Comment: insufficient information

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Quote: "Masking/Blinding: none"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity:

Quote: "Masking/Blinding: none"

Incomplete outcome data (attrition bias)
All outcomes

High risk

Participant flow diagram provided

Attrition in intervention group attributable to group allocation (8 participants had valves removed and not included at 6‐month assessment)

Selective reporting (reporting bias)

High risk

PRIMARY OUTCOMES
Registry: FVC, FEV1, 6MWD (secondary outcomes in paper)

Manuscript: daily physical activity (not in registry)

SECONDARY OUTCOMES

Paper: SGRQ, dyspneoa (additional outcomes)

Other bias

Low risk

N/A

Holland 2017

Methods

DESIGN 2 groups

DATES October 2011 to September 2014

SETTING 2 hospital‐based outpatient PR programmes (Australia)

SAMPLE SIZE calculation based on CRQ and 6MWD

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (FER < 0.7)

  • Smoking history (current or former) > 10 pack‐years

  • Age < 40 years

EXCLUSION CRITERIA

  • Diagnosis of asthma

  • PR within 2 years

  • AECOPD within 4 weeks

  • Other comorbidities to prevent participation in exercise training

BASELINE CHARACTERISTICS

  • INTERVENTION home‐based PR (n = 80, physical activity data n = 29)

AGE mean 69 (SD 13) years; SEX 48 (60%) male; FEV1 mean 52 (SD 19)% predicted

  • INTERVENTION centre‐based PR (n = 86, physical activity data n = 38)

AGE mean 69 (SD 10) years; SEX 51 (60%) male; FEV1 mean 49 (SD 19)% predicted

Interventions

DURATION OF INTERVENTION 8 weeks

FOLLOW‐UP 12 months

SUPERVISION No

INTERVENTION home‐based PR

SETTING home

CONTACT

  • initial home visit: gait aid, other referrals, exercise prescription and exercise goals, inhaler technique

  • 7 weekly structured phone calls

AEROBIC TRAINING

  • 5 sessions a week, ≥ 30 minutes, accessible modality (usually walking)

  • INITIAL PRESCRIPTION 80% baseline 6MWT average speed

  • TRAINING walking distance goal set, distance recorded using pedometer

STRENGTH TRAINING functional activities and equipment accessible in home, including sit‐to‐stand from a dining chair, step ups on an internal or external step, and water bottles for upper limb weights

OTHER COMPONENTS

  • home‐based sessions (distance walked)

  • exercise goals discussed and documented each week (phone call)

EDUCATION

  • Menu of topics relevant to COPD self‐care and encouraged to select a topic of relevance to them for discussion each week (phone call)

  • Better Living with COPD booklet

INTERVENTION centre‐based PR

SETTING outpatient group

CONTACT 2 sessions a week

AEROBIC TRAINING ≥ 30 minutes

  • walking (treadmill or corridor)

    • INITIAL PRESCRIPTION 80% baseline 6MWT average speed

  • cycle training

    • INITIAL PRESCRIPTION 60% maximal work rate

    • PROGRESSION weekly, based on symptoms

STRENGTH TRAINING functional activities such as stair climbing and sit‐to‐stand practice, as well as free weights for the upper limbs

OTHER COMPONENTS Unsupervised home exercise programme 3 sessions a week

EDUCATION Self‐management training: structured (lecture‐based) and unstructured disease management education and goal setting (management of exacerbations, understanding medications, ongoing participation in exercise)

Outcomes

DEVICE SenseWear Armband (software version 7.0) (left upper arm)

  • Wear instructions: 7 days (remove for bathing or water‐based activities)

  • Data inclusion criteria: ≥ 4 days (≥ 1 weekend day), ≥ 10 hours wear time, excluding first and last days

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 8 weeks

  • Follow‐up: 12 months post‐intervention

PRIMARY OUTCOME

  • Exercise capacity: 6MWD

  • HRQOL: CRQ

SECONDARY OUTCOMES

  • Physical activity: step count, sedentary time (≥ 1.5 METs), MVPA time (≥ 3 METs), EE

  • Adherence: reported

  • Adverse events: reported

  • Other: dyspnoea, self efficacy for PR, anxiety and depression, comorbidities, hospitalisation, programme cost

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Anne Holland [email protected] Alfred Health, Melbourne (Australia)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "A randomised, controlled equivalence trial… using a computer generated sequence… generated by an individual unrelated to the study"

Allocation concealment (selection bias)

Low risk

Quote: "randomised to treatment groups… using a computer generated sequence that was concealed using opaque envelopes"

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention.

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:
Quote: "All subsequent assessments were performed by an individual blinded to group allocation, who had no involvement in provision of either intervention. The success of assessor blinding was evaluated after the 12‐month assessment by asking the assessor to nominate the group to which they thought the participant had been assigned…At the end of the trial, the assessors correctly identified group allocation for 52% of participants (κ=0.26), demonstrating the success of blinding"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Unclear risk

SECONDARY OUTCOMES

Protocol: Spirometry will be repeated at 12 months (only baseline reported)

Other bias

Low risk

Quote: "We made every attempt to assess all participants at all time points, even if they were unwell or had not completed the programme. This may have affected the overall magnitude of benefit, but is reflective of the real world challenges of pulmonary rehabilitation"

"Importantly, the programme completion rate in the centre‐based group was low, which may not reflect completion rates in all real world centre‐based services and may limit the generalisability of results"

Hornikx 2015

Methods

DESIGN 2 groups

DATES March 2013 to April 2014

SETTING hospital (Belgium)

SAMPLE SIZE calculation based on walking time

Participants

INCLUSION CRITERIA

  • COPD (post‐bronchodilatation FER < 0.7)

  • Age > 40 years

  • Hospitalised for AECOPD

  • Ability to work with electronic devices

EXCLUSION CRITERIA

  • PR prior to the index hospital admission (and would return to programme after discharge)

  • Neurological or musculoskeletal disease to prevent being active

BASELINE CHARACTERISTICS

  • INTERVENTION PAC (n = 15, completed n = 12)

AGE mean 66 (SD 7) years; SEX 8 (53%) male; FEV1 mean 38 (17%)% predicted

  • NO INTERVENTION (n = 15)

AGE mean 68 (SD 6) years; SEX 9 (60%) male; FEV1 mean 48 (18%)% predicted

Interventions

DURATION OF INTERVENTION 4 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION PAC

INTERFACE 3 phone calls a week

ACTIVITY not specified

STEP‐TRACKING pedometer (direct feedback)

GOALS progress report with tips to increase physical activity posted Week 2 and Week 4

RECORD, EDUCATION/RESOURCES nil

NO INTERVENTION provided with advice about increasing physical activity during the hospital stay from a physiotherapist

Outcomes

DEVICE Dynaport MoveMonitor (lower back at the height of the second lumbar vertebra)

  • wear instructions, data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • During hospital stay (all outcomes)

  • Mid‐intervention: 2 weeks (physical activity)

  • End intervention: 4 weeks (all outcomes)

PRIMARY OUTCOME

  • Physical activity: step count, time walking, walking intensity

SECONDARY OUTCOMES

  • HRQOL: CAT

  • Exercise capacity: 6MWD "Patients included in the study were all familiar with the 6MWD. For this reason and for not burdening the patients too much, only 1 test was executed."

  • Adverse events: reported

  • Adherence: not reported

  • Other: spirometry, dyspnoea, peripheral muscle strength

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Thierry Troosters [email protected] KU Leuven (Belgium)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Eligible patients were randomized"

Comment: insufficient information

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity: not specified

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

High risk

PRIMARY OUTCOMES

Registry: step count

Paper: step count, time walking (used for sample size calculation), walking intensity

SECONDARY OUTCOMES

Paper: spirometry, peripheral muscle strength, dyspnoea, CAT (additional outcomes reported)

Paper: hospital readmission, medications, PR enrolment (results presented, not in methods)

Other bias

Unclear risk

Quote: "By executing this study, we experienced that including patients after an exacerbation of COPD is very difficult. After 1 year, only 30 patients agreed to participate in the study. Intermediate analyses did not reveal better improvements in physical activity in the group that received maximal counselling and real‐time feedback compared to usual care. Based on these conclusions and the fact that the study was very time consuming for the researcher, we decided not to continue with the study"

Hospes 2009

Methods

DESIGN 2 groups

DATES not reported

SETTING hospital pulmonary outpatient clinic (The Netherlands)

SAMPLE SIZE "a power analysis was calculated" (outcome not stated)

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD

  • Age 45 to 75 years

EXCLUSION CRITERIA

  • Comorbidity that may limit physical activity

BASELINE CHARACTERISTICS

  • INTERVENTION PAC (n = 20, completed n = 18)

AGE mean 63 (SD 9) years; SEX 10 (50%) male; FEV1 mean 68 (SD 18)% predicted

  • NO INTERVENTION (n = 19, completed n = 17)

AGE mean 61 (SD 9) years; SEX 11 (58%) male; FEV1 mean 62 (SD 14)% predicted

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION pac (in‐person, Altenburg 2015, De Blok 2006)

INTERFACE 5 individual sessions

ACTIVITY lifestyle physical activity (e.g. walking, cycling, stair‐climbing, gardening)

STEP‐TRACKING pedometer (direct feedback)

RECORD Diary: daily step count, other activities (e.g. cycle, swim)

GOALS “maximal” step count goal, end intervention: set personal “physical activity norm” (between mean and maximal step count) goal

EDUCATION/RESOURCES nil

Outcomes

DEVICE Digiwalker SW‐2000 (pedometer)

  • Wear instructions:

    • usual care: 2 weeks at baseline and 10 weeks after baseline

    • intervention group: all day during the intervention period

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks (unclear if pedometer values are from the last week of intervention)

OUTCOMES

  • Physical activity: step count

  • HRQOL: CCQ, SGRQ, SF36

  • Exercise capacity: 6MWD

  • Adherence: not reported

  • Adverse events: reported

  • Other: spirometry, muscle strength, fatigue, depression, self‐efficacy, exercise self‐regulation

Notes

FUNDING "This study was supported by a research grant from Boehringer Ingelheim B.V. The funding source(s) had no involvement in the study."

CONFLICT OF INTEREST "Herewith we state that none of the authors had any actual or potential conflict of interest including any financial, personal or other relationships with other people or organizations within 3 years of beginning the submitted work that could inappropriately influence, or be perceived to influence, their work."

CONTACT Linda Bossenbroek [email protected] University Medical Center Groningen (The Netherlands)

Additional information requested.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Patients were randomly assigned…"

Comment: insufficient information

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity: unclear if step count was reported by participants

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity: not specified

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

Unclear risk

No trial registry; results presented as in Methods apart from subgroups for step count in Results (justification presented in Discussion)

Other bias

Low risk

N/A

Jolly 2018

Methods

DESIGN 2 groups

DATES March 2014 to December 2016

SETTING 71 general practices (UK)

SAMPLE SIZE calculation based on SGRQ

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (post‐bronchodilator FER < 0.7)

  • Age > 18 years

  • Respiratory symptoms consistent with COPD

  • MRC dyspnoea scale (score 1 or 2) and those without a recorded dyspnoea score

EXCLUSION CRITERIA

  • Inappropriate for the study terminal disease, severe psychiatric disorder)

  • MRC dyspnoea scale (score ≥ three)

N.B. use of population descriptor as 'mild' refers to mMRC grade

FEV1 ≥ 80% predicted: 89 of 289 (31%) participants in intervention group and 104 of 288 (36%) participants in no‐intervention group so does not meet review definition for subgroup analyses

BASELINE CHARACTERISTICS

  • INTERVENTION self‐management (telephone health coaching) (n = 289)

AGE mean 71 (SD 9) years, SEX 183 (63%) male; FEV1 mean 71 (SD 19)% predicted

  • NO INTERVENTION (n = 288)

AGE mean 70 (SD 8) years; SEX 183 (64%) male; FEV1 mean 72 (SD 19)% predicted

Interventions

DURATION OF INTERVENTION 6 months

FOLLOW‐UP no

SUPERVISION no

INTERVENTION self‐management (telephone health coaching)

INTERFACE telephone by a nurse with

  • 1 initial 35‐ to 60‐minute coaching session 1 week post‐randomisation

  • 3 15‐ to 20‐minute telephone contacts over 3 months

STEP‐TRACKING pedometer

RECORD self‐monitoring diary

EDUCATION/RESOURCES

  • smoking cessation advice, encouragement to become physically active, correct inhaler technique, medication adherence

  • for participants with recurrent AECOPD with action plan and rescue pack of antibiotics or steroids, exploration of confidence in early identification of AECOPD and medication commencement

  • written materials

    • individually tailored following telephone contacts (e.g. summary of goals agreed, physical activity diary, contact details for local services, information leaflet showing correct inhaler technique)

    • standard information at 16 and 24 weeks.

Outcomes

DEVICE GENEActiv [non‐dominant wrist]

  • Wear instructions: 7 days

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • End intervention: 6 months

  • Follow‐up: 12 months

PRIMARY OUTCOME

  • HRQOL: SGRQ

SECONDARY OUTCOMES

  • Physical activity: MVPA time (> 678 cpm)

  • HRQOL: EQ5D

  • Exercise capacity: not assessed

  • Adherence: reported

  • Adverse events: reported

  • Other: dyspnoea, physical activity (subjective), self‐efficacy, smoking cessation

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Kate Jolly [email protected] University of Birmingham, Birmingham (UK)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "individually randomised in a 1:1 ratio to the telephone health coaching or usual care group stratified by centre. The allocation was made using a web‐based programme hosted by the Primary Care Clinical Research and Trials Unit, University of Birmingham. Centre specific randomisation lists were produced by a statistician at the trials unit"

Allocation concealment (selection bias)

Low risk

Quote: "Only the Primary Care Clinical Research and Trials Unit had access to the allocation sequence. Patients were informed of their allocation at the end of the recruitment appointment"

Blinding of participants (performance bias)

High risk

Quote: "Patients… were not masked to treatment allocation"

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL:
Quote: "data were entered into the study database by researchers at the University of Birmingham who were masked to the treatment allocation" (postal responses)

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Participant flow diagram provided

Selective reporting (reporting bias)

Unclear risk

PRIMARY OUTCOME (SGRQ)

Registry: 6 and 12 months; Paper: 12 months only

SECONDARY OUTCOMES

Registry: none specified

Other bias

Low risk

N/A

Kanabar 2015

Methods

DESIGN 2 groups

DATES not reported (abstract only)

SETTING "following discharge from a respiratory‐related admission" (UK)

SAMPLE SIZE not reported (abstract only)

Participants

INCLUSION/EXCLUSION CRITERIA not reported

BASELINE CHARACTERISTICS

  • INTERVENTION self‐management (SPACE) (n = 15)

AGE mean 68 (SD 9) years; SEX 7 (47%) male; FEV1 mean 36 (SD 12)% predicted

  • NO INTERVENTION (n = 10)

AGE mean 67 (SD 4) years; SEX 4 (40%) male; FEV1 mean 48 (SD 13)% predicted

Interventions

DURATION OF INTERVENTION 7 days

FOLLOW‐UP no

SUPERVISION no

INTERVENTION self‐management (SPACE) (as in Mitchell 2013)

brief physical activity advice in the form of a self‐management manual

Outcomes

DEVICE SenseWear armband Pro3 (software version not reported)

  • Wear instructions: 7 days post‐discharge, 12 waking hours

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS daily for 7 days

OUTCOMES

  • Physical activity: step count, sedentary time (threshold not defined), LIPA time, MPA time (3 to 6 METs), VPA time (≥ 6 METs), PAL, total EE, active EE (≥ 3 METs)

  • HRQOL: not assessed

  • Exercise capacity: ISWD, ESWT

  • Adherence: not reported

  • Adverse events: not reported

Notes

FUNDING, CONFLICT OF INTEREST not reported (abstract only)

CONTACT Sally Singh sally.singh@uhl‐tr.nhs.uk University Hospitals Of Leicester NHS Trust, Leicester (UK)

Additional information provided: group demographics, physical activity and exercise outcomes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Randomised controlled trial"

Comment: Insufficient information (abstract only)

Allocation concealment (selection bias)

Unclear risk

Not specified (abstract only)

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified (abstract only)

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

Exercise capacity: not specified (abstract only)

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Total number randomised and group numbers provided; no details re attrition or exclusion (abstract only)

Selective reporting (reporting bias)

High risk

Paper:

  • Methods: step count, time in light, mode and vigorous activity, physical activity level, total energy expenditure

  • Results: step count data presented in graph, other outcomes "no significant difference between the groups. This was the same for all of the other activity monitor data"

Other bias

Low risk

N/A

Kawagoshi 2015

Methods

DESIGN 2 groups

DATES not reported

SETTING (Japan)

SAMPLE SIZE not reported

Participants

INCLUSION CRITERIA

  • Stable condition (no infection or AECOPD within 3 months)

  • Able to walk unassisted

  • Able to operate the device to measure their physical activity

EXCLUSION CRITERIA

  • No severe and/or unstable cardiac disease, orthopaedic disease, or mental disorder that could impair physical activities in daily life

BASELINE CHARACTERISTICS

  • INTERVENTION PAC with PR (n = 19, completed n = 12)

AGE mean 64 (SD 8) years; SEX 16 (83%) male; FEV1 mean 58 (SD 23)% predicted

  • INTERVENTION PR (n = 20, completed n = 15)

AGE mean 75 (SD 9) years; SEX 19 (93%) male; FEV1 mean 61 (SD 21)% predicted

Interventions

DURATION OF INTERVENTION 12 months

FOLLOW‐UP no

SUPERVISION no

COMMON INTERVENTION PR

SETTING home

CONTACT

  • Fortnightly: hospital‐based review for exercise progression

  • Periodically: nurse home visit

AEROBIC TRAINING daily, ≥ 15 minutes, level walking

  • TRAINING INTENSITY dyspnoea scale (rating 3)

STRENGTH TRAINING upper and lower limbs, daily

OTHER COMPONENTS

  • Breathing retraining (supine and sitting): pursed‐lip breathing, diaphragmatic breathing, slow‐deep breathing

  • Unsupervised home inspiratory muscle training

    • COMMENCEMENT 30 to 40% Pimax

EDUCATION monthly, 45 minutes: equipment use, nutrition, stress management, relaxation techniques, home exercises, the benefits of pulmonary rehabilitation

INTERVENTION PAC

INTERFACE monthly (or fortnightly) individual session

ACTIVITY not specified

STEP‐TRACKING Pedometer Kens Lifecorder EX (no direct feedback)

GOALS 8000 steps a day

  • Pedometer download and feedback during intervention (11 times)

RECORD, EDUCATION/RESOURCES nil

Outcomes

DEVICE Activity Monitoring and Evaluation System (A‐MES tri‐axial accelerometer) (attached on thigh and chest in clothing pockets)

  • "Each patient was given an A‐MES, an instruction book, and the appropriate clothing, and we instructed the patients to measure their physical activity themselves"

  • Wear instructions: 7 consecutive days, from waking time for 12 hours

  • Data inclusion criteria: ≥ 2 days

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 months

PRIMARY OUTCOME

  • Physical activity: time walking, time standing, time sitting, time lying, frequency of postural changes (getting‐up, standing‐up, total)

SECONDARY OUTCOMES

  • HRQOL: CRQ

  • Exercise capacity: 6MWD

  • Adherence: reported

  • Adverse events: reported

  • Other: spirometry, dyspnoea, muscle force

Notes

FUNDING not reported

CONFLICT OF INTEREST statement provided

CONTACT Atsuyoshi Kawagoshi [email protected] Akita City Hospital, Akita (Japan)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "The patients were randomly assigned to one of two groups"

Comment: Not specified

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Quote: "Patients were not blinded to the randomization"

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity: not specified

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Unclear risk

No trial registry; results presented as in Methods

Other bias

Low risk

N/A

Larson 2014

Methods

DESIGN 3 groups (2 comparisons)

  • exercise‐specific self‐efficacy intervention with upper‐body resistance training vs. health education with upper‐body resistance training

  • health education with upper‐body resistance training vs. health education with gentle chair exercises

DATES not reported

SETTING (USA)

SAMPLE SIZE calculation based on LIPA time

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (moderate to severe; FEV1 < 80% predicted, FER < 0.7)

  • Age ≥ 45 years

  • Stable clinical condition

  • No other major health problems that limited physical activity

  • Experienced dyspnoea during upper‐body activity

EXCLUSION CRITERIA

  • Require an assistive device to walk

BASELINE CHARACTERISTICS

  • INTERVENTION exercise‐specific self‐efficacy intervention with upper‐body resistance training (n = 28, Month 4 n = 15, Month 12 n = 10)

AGE mean 71 (SD 8) years; *SEX not reported; FEV1 mean 61 (SD 20)% predicted

  • INTERVENTION health education with upper‐body resistance training (n = 29, Month 4 n = 20, Month 12 n = 15)

AGE mean 72 (SD 9) years; *SEX not reported; FEV1 mean 54 (SD 17)% predicted

  • INTERVENTION health education with gentle chair exercises (n = 28, Month 4 n = 14, Month 12 n = 9)

AGE mean 71 (SD 8) years; *SEX not reported; FEV1 mean 56 (SD 17)% predicted

*"small proportion of women"

Interventions

DURATION OF INTERVENTION 4 months

FOLLOW‐UP 12 months

SUPERVISION yes

INTERVENTION upper‐body resistance training

SETTING outpatient group

CONTACT 2 sessions a week, 90 minutes supervised upper‐limb training

  • incorporates weekly 15 minutes self‐efficacy or health education session, 16 sessions

AEROBIC TRAINING nil

STRENGTH TRAINING cable cross‐over system: shoulder shrug, modified latissimus dorsi pulldown, overhead pulldown, front pulldown, front raise, upright row, biceps curl, triceps extension

  • INITIAL PRESCRIPTION 70% 1RM (2 sets, 8 to 10 repetitions)

  • PROGRESSION Week 1 to Week 4: increased to 80% 1RM, Week 5 to Week 16: 80% 1RM (3 sets, 8 to 10 repetitions)

  • OTHER COMPONENTS weekly, home (1 set, 10 to 20 repetitions), dumbbells (2 to 15 lbs), Borg scale rating of perceived exertion (rating 12)

INTERVENTION exercise‐specific self‐efficacy intervention

general principles of exercise, coping with respiratory infections by modifying PA, overcoming barriers to exercise, establishing an active lifestyle

INTERVENTION health education

basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating, relaxation, travel considerations, energy conservation, osteoarthritis, cardiovascular risk factors, cholesterol

INTERVENTION gentle chair exercises

stretching and toning exercises that were not aerobic

Outcomes

DEVICE Actigraph (model 7164) (software version not reported) (waist)

  • Wear instructions: 7 consecutive days, waking hours

  • Data inclusion criteria: ≥ 3 days, ≥ 10 hours a day

    • non‐wear time defined as < 60 minutes of zero counts

    • "A second accelerometer was worn on the wrist of the dominant hand to validate wear time for the waist‐mounted accelerometers...We assumed that waist and wrist accelerometers were both worn together, and when the duration of zero counts was ≥ 60 minutes for data collected from the waist accelerometer, we checked the wrist data to determine if the wrist was active. If data from the wrist accelerometer and data from the activity log indicated that the subject was still being monitored, then the waist data were treated as valid and not removed as nonwear time."

  • Daily activity log that was used to facilitate interpretation of accelerometry data

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 4 months

  • Follow‐up: 8 months post‐intervention

OUTCOMES

  • Physical activity: sedentary time (≤ 100 cpm), LIPA time (100 to 1951 cpm), MVPA time (≥ 1952 cpm)

  • HRQOL: not assessed

  • Exercise capacity: not assessed

  • Adherence: not reported

  • Adverse events: not reported

  • Other: self‐reported functional performance

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Janet Larson [email protected] University of Michigan (USA)

Additional information requested.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomization was stratified by sex and disease severity (GOLD stages) using a customized computer program that blinded investigators to group assignment [software program (biased coin algorithm to ensure equivalent groups)"

Allocation concealment (selection bias)

Unclear risk

Quote: "concealed allocation process"

Comment: Not specified

Blinding of participants (performance bias)

Low risk

"All subjects were assigned to an active intervention without being told which intervention was the experimental intervention of interest. We explained that all three interventions were potentially beneficial and that we were comparing the effects of each"

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

N/A

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Unclear risk

PRIMARY OUTCOMES

Trial registry: not reported

  • upper‐body strength and dyspnoea (not in paper)

  • time points: before training, after training, 6 and 12 months post‐training (no 6‐month follow‐up in paper)

Paper: physical activity (additional outcome)

Other bias

Unclear risk

Retrospectively registered in January 2010; study started September 2003, primary completion January 2009

Loeckx 2018

Methods

DESIGN 2 groups

DATES, SETTING, SAMPLE SIZE not provided (abstract only)

Participants

INCLUSION CRITERIA

"Patients with COPD enrolled in a conventional 6 month OP PRP were screened for eligibility. After 3 months of PR and one week of PA measurements"

EXCLUSION CRITERIA

not provided (abstract only)

  • BASELINE CHARACTERISTICS (TOTAL n=50)

AGE not reported; SEX 25 (50%) male; FEV1 mean 49 (SD 20)% predicted

  • INTERVENTION PAC with PR (n = 25)

  • INTERVENTION PR (n = 25)

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP 6 months

SUPERVISION yes

INTERVENTION PAC

"Coaching through a semi‐automated telecoaching program consisting of a step counter and a project‐tailored smartphone application" (Demeyer 2017)

INTERVENTION PR

Outcomes

DEVICE not reported (abstract only)

ASSESSMENT TIME POINTS

  • Baseline (after 3 months of PR)

  • End intervention: (after 3 months of intervention, 6 months of PR)

  • Follow‐up: 6 months

PRIMARY/SECONDARY OUTCOMES

  • Physical activity: step count, MVPA time

  • HRQoL: CRQ dyspnoea

  • Exercise capacity: 6MWD, endurance time (cycle ergometry)

Notes

FUNDING, CONFLICT OF INTEREST not provided (abstract only)

CONTACT Matthias Loeckx [email protected] KU Leuven (Belgium)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information (abstract only)

Allocation concealment (selection bias)

Unclear risk

Insufficient information (abstract only)

Blinding of participants (performance bias)

Unclear risk

Insufficient information (abstract only)

Blinding of personnel (performance bias)

Unclear risk

Insufficient information (abstract only)

Blinding of outcome assessment [objective] (detection bias)

Unclear risk

Insufficient information (abstract only)

Blinding of outcome assessment [other] (detection bias)

Unclear risk

Insufficient information (abstract only)

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient information (abstract only)

Selective reporting (reporting bias)

Unclear risk

Insufficient information (abstract only)

Other bias

Unclear risk

Insufficient information (abstract only)

Lord 2012

Methods

DESIGN 2 groups

DATES January 2009 to August 2009

SETTING respiratory clinics (UK)

SAMPLE SIZE calculation based on SF36

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD criteria)

EXCLUSION CRITERIA not reported

BASELINE CHARACTERISTICS

  • INTERVENTION singing (n = 13)

AGE mean 69 (SD 11) years; SEX not reported; FEV1 mean 44 (SD 14)% predicted

  • SHAM film workshops (n = 11)

AGE mean 68 (SD 9) years; SEX not reported; FEV1 mean 64 (SD 26)% predicted

Interventions

DURATION OF INTERVENTION 8 weeks

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION singing

  • 8 weeks, 2 classes a week, 1 hour

  • vocal exercises, posture and relaxation

  • daily at home: CD of physical warm‐ups, breathing exercises and songs

SHAM film workshops

  • 1 workshop a week, 1 hour

    • watched the film then discussion

Outcomes

DEVICE SenseWear Pro (software version not reported)

  • Wear instructions: 7 days

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 8 weeks

PRIMARY OUTCOME

  • HRQOL: SF36

SECONDARY OUTCOMES

  • Physical activity: sedentary time, time in physical activity, active EE (thresholds not defined)

  • HRQOL: CAT

  • Exercise capacity: ISWD

  • Adherence: not reported

  • Adverse events: not reported

  • Other: anxiety and depression, control of breathing, qualitative assessments

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Nicholas Hopkinson [email protected] Imperial College, London (UK)

Additional information requested

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "At the end of the baseline visit, patients were randomized to either the singing classes or the film workshops, using randomization in blocks of 4…The sequence was developed by NSH who was not involved with the day to day conduct of the trial"

Allocation concealment (selection bias)

Low risk

Quote: "consecutive sequentially numbered sealed envelopes"

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention.

Blinding of personnel (performance bias)

Unclear risk

Quote: "The co‐ordinators of each session were unaware of the tests measured at baseline"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity:

Quote: "Following attendance to either group for eight weeks, baseline measurements were again assessed by the same respiratory physiotherapists, who were blinded to treatment allocation"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

High risk

PRIMARY OUTCOME

Registry: daily physical activity

Paper: SF36 (not in registry)

SECONDARY OUTCOMES

Paper: control of breathing, qualitative assessments (additional outcomes reported)

Other bias

Unclear risk

Retrospectively registered

Louvaris 2016

Methods

DESIGN 2 groups

DATES October 2013 to July 2016

SETTING outpatient PR programme (Greece)

SAMPLE SIZE not reported

Participants

INCLUSION CRITERIA (as in Nasis 2015)

  • Diagnosis of COPD (post‐bronchodilator FEV1 < 80% predicted)

  • Absence of significant airway reversibility (< 12% change or < 200 ml of pre‐bronchodilation FEV1)

  • Disease stability within 6 months

  • Optimal medical therapy for COPD (GOLD Guidelines 2011)

EXCLUSION CRITERIA (as per Nasis 2015)

  • Medical history of cor pulmonale, cardiovascular disease

  • Musculoskeletal abnormalities or other condition that may limit exercise

BASELINE CHARACTERISTICS

  • INTERVENTION exercise training (HIIT) (n = 85)

AGE mean 65 (SD 8) years; SEX 68 (80%) male; FEV1 mean 49 (SD 19)% predicted

  • NO INTERVENTION (n = 43)

AGE mean 67 (SD 8) years; SEX 36 (84%) male; FEV1 mean 45 (SD 19)% predicted

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION exercise training (HIIT)

SETTING centre‐based outpatient group

CONTACT 3 sessions a week

AEROBIC TRAINING cycling 45 minutes, alternating 30‐second exercise intervals with 30‐second rest periods

  • INITIAL PRESCRIPTION 130 (18)% peak work rate from baseline assessment

STRENGTH TRAINING upper and lower limbs

  • INITIAL PRESCRIPTION 70% 1RM

OTHER COMPONENTS nil

EDUCATION education programme: breathing retraining, dietary advice

Outcomes

DEVICE Actigraph GT3X (ActiLife software (version 5.10.0)

  • Wear instructions: 7 consecutive days

  • Data inclusion criteria: ≥ 4 days, 480 minutes a day (between 07:00 and 20:00)

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks

PRIMARY OUTCOME

  • Physical activity: step count, vector magnitude units, sedentary time, time in light, lifestyle and moderate‐intensity physical activity (data from table, thresholds not defined)

SECONDARY OUTCOMES

  • HRQOL: CCQ, CRQ, CAT

  • Exercise capacity: peak work rate (cycle ergometry), 6MWD

  • Adherence: not reported

  • Adverse events: not reported

  • Other: spirometry, body composition, dyspnoea, anxiety and depression, muscle force and endurance

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Ioannis Vogiatzis [email protected] Zafeiris Louvaris [email protected] National and Kapodistrian University of Athens (Greece)

Additional information provided:

  • Table 2 values for post‐intervention results for steps and light‐intensity physical activity (discrepancy noted with data in text)

  • confirmed that Kortianou 2014 presented a subset of these data

  • physical activity thresholds as in manufacturer recommendations

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Patients were randomised…in random block sizes of three and six."

Allocation concealment (selection bias)

Low risk

Quote: "sealed opaque envelopes"

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention.

Blinding of personnel (performance bias)

Unclear risk

Not specified (research letter only)

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity and exercise capacity (cycle ergometry)

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity (6MWD):

Quote: "experienced, health professionals who were blinded to group allocation performed all categories of assessment"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No participant flow diagram (research letter only)

Quote: "150 consecutive COPD patients were screened… Patients were randomised in a 2:1 ratio into the interval training group (n=85) or the usual care group (n=43)"

Attrition and exclusions not reported.

Selective reporting (reporting bias)

High risk

Referral to trial registry is not study‐specific.

  • Allocation: non‐randomised

  • Intervention model: parallel assignment

  • Masking: none (open‐label)

PRIMARY OUTCOMES

Registry: PROactive tool (not reported)

Paper: physical activity variables (daily activity levels amount and intensity, sedentarism, wear time, step count, VMU, time in sedentary, light, lifestyle and moderate activities)

SECONDARY OUTCOME

Registry: daily physical activity (number of steps, VMU per activity minute, walking intensity)

Paper: spirometry, anthropometry, exercise capacity, muscle strength, dyspnoea, HRQOL (CAT, CCQ, CRQ), anxiety and depression (additional outomces reported)

Other bias

Unclear risk

Registry: no reference to HIIT protocol

Maddocks 2016

Methods

DESIGN 2 groups

DATES Screened between June 2012 and July 2014

SETTING multidisciplinary respiratory and palliative care meetings and across PR services, 3 National Health Service trusts, London, UK

SAMPLE SIZE calculation based on 6MWD

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (FER ≤ 0.7)

  • Severe respiratory impairment (GOLD stage III to IV; FEV1 ≤ 50% predicted)

  • Age ≥18 years

  • Incapacitating breathlessness (MRC dyspnoea score 4 or 5)

EXCLUSION CRITERIA

  • Cardiac pacemaker

  • Co‐existing neurological condition

  • Change in medication or AECOPD requiring admission within 4 weeks

  • Recent systemic corticosteroids (≥ 5 consecutive days within 4 weeks)

  • Current regular exercise (structured training ≥ 3 times a week within last month)

BASELINE CHARACTERISTICS

  • INTERVENTION neuromuscular electrical stimulation (n = 25)

AGE mean 70 (SD 11) years; SEX 11 (44%) male; FEV1 mean 31 (SD 11)% predicted

  • PLACEBO (n = 27)

AGE mean 69 (SD 9) years; SEX 10 (37% male); FEV1 mean 31 (SD 13)% predicted

Interventions

DURATION OF INTERVENTION 6 weeks

FOLLOW‐UP 6 weeks

SUPERVISION no

COMMMON INTERVENTION neuromuscular electrical stimulation

  • battery‐powered unit (2‐channel MicroStim Exercise Stimulator MS2v2, Odstock Medical Ltd, Wiltshire, UK)

  • self‐adhesive platinum electrodes placed over distal and proximal body of each quadriceps

ADMINISTRATION self‐administered, 30 minutes daily

frequency 50Hz, pulse width 350µs, duty cycle 11% to 50% (equivalent to 15% to 25% of maximum voluntary contraction)

INSTRUCTION standardised 30 minutes face‐to‐face training, supervise first set‐up in hospital or home (participant preference)

  • written instructions

  • self‐report diary

  • weekly telephone calls

  • home visits as required

INTERVENTION amplitude 0 to 120mA over 1000O

proportion of active treatment duration: increase weekly from 11% to 25% to 50%, then constant

PLACEBO amplitude 0 to 20mA

"levels of stimulation detectable by the patient but not able to elicit a tetanic muscle contraction"

Outcomes

DEVICE activPAL (PAL Technologies,Glasgow, UK)

  • Wear instructions: 6 days, ≥ 21 hours

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 6 weeks

  • Follow‐up: 12 weeks

PRIMARY OUTCOME

  • Exercise capacity: 6MWD

SECONDARY OUTCOMES

  • Physical activity: step count, time spent upright, number of sit‐to‐stand transitions

  • HRQOL: CRQ, SGRQ, EQ5D

  • Exercise capacity: 6MWD

  • Adherence: concealed in‐built logger (number of times device switched on, total duration of use)

  • Adverse events:

  • Also: quadriceps maximum voluntary contraction, twitch with femoral nerve stimulation, rectus femoris cross‐sectional area, FFM, participant experiences, service utilisation

Notes

FUNDING "The funder of the study had no role in the study design, data collection, data analysis, data interpretation, or

writing of the report. This study was funded by National Institute for Health Research (NIHR; PDF‐2011‐04‐048). This study represents independent research supported by the UK Clinical Research Collaboration‐registered King’s Clinical Trials Unit at King’s Health Partners, and the NIHR/Wellcome Trust King’s Clinical Research Facility, which are part funded by the NIHR Biomedical Research Centre for Mental Health and the Dementia Unit at South London and Maudsley NHS Foundation Trust, King’s College London and the NIHR Evaluation, Trials and Studies Coordinating Centre. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health … MM is supported by an NIHR Post‐Doctoral Fellowship (PDF‐2011‐04‐048) and Clinical Trials Fellowship (CTF‐2013‐02‐009). CMN is supported by an NIHR Doctoral Fellowship (DRF‐2014‐07‐089). WD‐CM is supported by an NIHR Clinician Scientist Award, a Medical Research Council (UK) New Investigator Research Grant, an NIHR Clinical Trials Fellowship and by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for Northwest London. MIP is supported by the NIHR Respiratory Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College London. IJH is an NIHR Senior Investigator and is supported by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for South London and Cicely Saunders International."

CONFLICT OF INTEREST "MIP reports receiving personal or institutional payment for consultancy or for research from GlaxoSmithKline, Novartis, Lilly, Pfizer, AstraZeneca, Regeneron, and Biomarin. MM, CMN, WD‐CM, NH, and IJH report holding grants from the National Institute for Health Research during the conduct of the trial. All other authors declare no competing interests."

CONTACT Matthew Maddocks [email protected] Kings College, London (UK)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Participants were randomly assigned (1:1) at the individual level, using an independent web‐based randomisation system within the independent UK Clinical Research Collaboration‐registered King’s Clinical Trials Unit (London, UK). Using a hybrid minimisation method, 20% of participants were entered using simple randomisation and 80% entered using computer‐generated probabilistic minimisation to balance three potential confounders"

Allocation concealment (selection bias)

Low risk

Quote: "Following randomisation to active or placebo NMES, the Clinical Trials Unit informed trial staff via secure email. The trial coordinator, who arranged subsequent masked assessment visits, was informed of trial entry but not group allocation"

Blinding of participants (performance bias)

Low risk

Quote: "Participants were not informed of group allocation"

Blinding of personnel (performance bias)

High risk

Quote: "Trial physiotherapists and nurses were informed of group allocation and selected an active or placebo NMES device accordingly"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

Quote: "Two linked Good Clinical Practice compliant online data entry systems (InferMed, London, UK; MACRO version 4) were created to maintain blinding; the first was used by physiotherapists and nurses for data regarding compliance and safety, and the second was used by trial assessors for outcome data"

"trial coordinator (masked to group allocation) undertook physical assessments; questionnaires were self‐completed independently by participants"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Low risk

Paper additionally reports 4‐metre gait speed and adverse events

Other bias

Unclear risk

Retrospectively registered

Quote: "One participant from each group commenced pulmonary rehabilitation classes during the follow‐up period, with three cumulative attendances between the 6‐week and 12‐week assessments in the active group and two in the placebo group."

Magnussen 2017

Methods

DESIGN cross‐over trial (only pre‐cross‐over data used), 2 groups

DATES April 2014 to June 2015

SETTING 2 centres (Germany)

SAMPLE SIZE "As this was a pilot study, no formal sample size calculation was performed"

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (moderate to severe; post‐bronchodilator FEV1 ≥ 40% to < 80% predicted, FER < 0.7)

  • Smoking history (current or former) ≥ 10 pack‐years

  • Age ≥ 40 years

EXCLUSION CRITERIA

  • Asthma

  • Apnoea–hypopnoea index ≥ 15 per hour

  • Respiratory infection, COPD exacerbation

  • Significant cardiovascular conditions

·MEDICATIONS

  • Inhaled salbutamol (100 μg) permitted as relief medication

  • Inhaled corticosteroids, oral or parenteral corticosteroids (equivalent to ≤ 10 mg a day of prednisone or 20 mg every other day) and oral sustained‐release theophyllines permitted as maintenance medication if treatment was stable for at least 4 weeks)

BASELINE CHARACTERISTICS

  • INTERVENTION LAMA (n = 15)

AGE mean 64 (SD 7) years; SEX 8 (53%) male; FEV1 median 1.4 (IQR 1.3 to 2.0) litres

  • PLACEBO (n = 15)

AGE mean 65 (SD 8) years; SEX 7 (47%) male; FEV1 median 1.4 (IQR 0.9 to 1.8) litres

Interventions

DURATION OF INTERVENTION 3 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION LAMA (aclidinium bromide, 400 μg) twice daily (09:00, 21:00 ± 1 hour) with a dry‐powder inhaler (Genuair®/Pressair®)

PLACEBO twice daily (09:00, 21:00 ± 1 hour) via a dry‐powder inhaler (Genuair®/Pressair®)

Outcomes

DEVICE SenseWear Pro3 (software version not reported)

  • Wear instructions: 7 days

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 3 weeks

OUTCOMES

  • Physical activity: step count, MVPA time (> 3 METs), PAL, active EE (> 3 METs),

  • HRQOL: CAT

  • Exercise capacity: not assessed

  • Adherence: not reported

  • Adverse events: reported

  • Other: polysomnography, symptom questionnaires

Notes

FUNDING "Support statement: This study was sponsored by Almirall S.A., Barcelona, Spain. Almirall S.A. were involved in the study design, collection, analysis, interpretation of data and development of this manuscript. Almirall S.A. and AstraZeneca Plc were involved in the review of the manuscript; the decision to submit the manuscript for publication was made jointly by the funders and authors. Funding information for this article has been deposited with the Crossref Funder Registry."

CONFLICT OF INTEREST "Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Publication of the results by the Investigator will be subject to mutual agreement between the investigator and sponsor." (registry)

CONTACT Henrik Watz [email protected] German Center for Lung Research, Grosshansdorf (Germany)

Additional data provided: as in Almirall

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Randomized"

Comment: insufficient information (research letter only)

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

Low risk

Quote: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)"

Blinding of personnel (performance bias)

Low risk

Quote: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL:

Quote: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No participant flow diagram (research letter only)

Selective reporting (reporting bias)

Low risk

Results presented as in registry

Other bias

Low risk

Quote: "per‐protocol population (all patients in the safety population who had no major protocol deviations)"

Mantoani 2018

Methods

DESIGN 2 groups

DATES February 2015 to March 2017

SETTING Community Treatment Centre and hospitals (UK)

SAMPLE SIZE calculation based on "physical activity levels"

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD criteria 2013)

  • Referred for PR

  • Clinical stability within 4 weeks

  • No myocardial Infarction, unstable angina, other significant cardiac problems, systolic blood pressure > 180 mmHg, diastolic blood pressure > 100 mmHg, tachycardia > 100 beats a minute within three months

  • Absence of significant orthopaedic, neurological, cognitive and/or psychiatric impairment restricting mobility

  • No exercise programme within 6 months

EXCLUSION CRITERIA

  • Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator

  • Respiratory diseases other than COPD (e.g. asthma)

  • AECOPD within 4 weeks

  • Cognitive impairment and inability to give informed consent, as judged by the investigator

  • Involvement in the planning or conduct of the study

  • Participants should not be taking part in any other studies

BASELINE CHARACTERISTICS (total n = 44)

AGE mean 69 (SD 11) years; SEX 22 (50%) male; FEV1 mean 54 (SD 19)% predicted

  • INTERVENTION PAC with PR

  • INTERVENTION PR

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP no

SUPERVISION no

COMMON INTERVENTION PR

DURATION 6 to 10 weeks

SETTING outpatient group

CONTACT 1 to 2 sessions a week, one hour

AEROBIC TRAINING treadmill, cycle ergometer

  • PROGRESSION weekly, work rate or duration, Borg scale dyspnoea and fatigue

STRENGTH TRAINING upper and lower limbs

OTHER COMPONENTS, EDUCATION nil

INTERVENTION PAC (web‐based human coaching)

DURATION 12 weeks

INTERFACE website

ACTIVITY not specified

STEP‐TRACKING Activity monitor (Tracmor D): (direct feedback, daily target)

RECORD nil

GOALS

  • Website: display progress, daily "physical activity" training (revised weekly)

  • 50% of initial "physical activity level" by end intervention

EDUCATION/RESOURCES nil

Outcomes

DEVICE

  • Tracmor D, Philips (triaxial sensor) (necklace, pocket or hip)

    • Week 1: initial physical activity levels established by DirectLife activity monitor… used to facilitate the behavioural intervention in the intervention group, but not as an outcome of physical activity level

    • Main variables: active time (minutes) and energy expenditure (calories)

  • Actigraph GT3x (hip)

    • Wear instructions: 7 days, ≥ 10 hours per day

    • Data inclusion criteria: nil

    • Outputs raw acceleration, energy expenditure, MET rates, steps, physical activity intensity, participant position

ASSESSMENT TIME POINTS

  • Baseline

  • Programme completion: 12 weeks

  • Follow‐up (optional): 12 weeks post‐intervention

PRIMARY

  • Physical activity: step count

SECONDARY

  • HRQOL: CRQ, CAT

  • Exercise capacity: ESWT

  • Adherence: not reported

  • Adverse events: not reported

  • Other: dyspnoea, acute exacerbation rate, anxiety and depression, self‐efficacy, motivation, strength, systemic inflammation

Notes

FUNDING "Sponsor: University of Edinburgh. Collaborator: Philips Healthcare"

CONFLICT OF INTEREST not reported (abstract only)

CONTACT not reported (abstract only)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "randomized controlled trial"

Comment: Insufficient information (abstract only)

Allocation concealment (selection bias)

Unclear risk

Not specified (abstract only)

Blinding of participants (performance bias)

High risk

Quote: "None (Open Label)"

Blinding of personnel (performance bias)

High risk

Quote: "None (Open Label)"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

High risk

HRQOL and exercise capacity:

Quote: "None (Open Label)"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not specified (abstract only)

Selective reporting (reporting bias)

Unclear risk

Insufficient information (abstract only)

Other bias

Unclear risk

  • recruitment started February 2015

    • Original estimated enrolment (January 2015) n = 64

    • Actual enrolment (November 2016) n = 46

  • delivery of intervention

    • February 2015 "Both groups will perform a 6 weeks standard exercise training programme used in the UK, 2 times per week"

    • July 2015 "Both groups will perform a 6‐10 weeks standard exercise training programme used in the UK, 1‐2 times per week"; additional study sites also identified

  • study design

    • February 2015

      • Visit 1 baseline

      • Visit 2 pulmonary rehabilitation completion (intervention group continues physical activity counselling and wearing monitor with feedback, other group is wearing monitor without feedback)

      • Visit 3 6‐week follow‐up

      • Visit 4 3‐month follow‐up (optional follow‐up period, no monitor)

    • July 2015

      • Visit 1 baseline

      • Visit 2 3 months after the beginning of pulmonary rehabilitation

      • Visit 3 3‐month follow‐up (optional follow‐up period, monitor without feedback)

Mendoza 2015

Methods

DESIGN 2 groups

DATES January 2011 to April 2013

SETTING outpatient clinics at private and public hospitals, private clinics, public primary health centres (Chile)

SAMPLE SIZE calculation based on step count

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD criteria 2006)

  • Smoking history ≥10 pack‐years, quit > 2 months ago

  • Age ≥ 40 years

  • No AECOPD within 4 weeks

EXCLUSION CRITERIA

  • Other chronic condition that significantly interfered with ability to walk

  • PR within 1 year

BASELINE CHARACTERISTICS

  • INTERVENTION: pedometer with PAC (n = 52)

AGE mean 69 (SD 10) years; SEX 29 (56%) male; FEV1 mean 66 (SD 18)% predicted

  • INTERVENTION: PAC (n = 50)

AGE mean 68 (SD 8) years; SEX 33 (66%) male; FEV1 mean 66 (SD 21)% predicted

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP no

SUPERVISION no

COMMON INTERVENTION PAC (in‐person)

INTERFACE monthly individual session

ACTIVITY walking

RECORD diary: daily symptoms

GOALS walk ≥ 30 minutes a day

STEP‐TRACKING, EDUCATION/RESOURCES nil

INTERVENTION pedometer

INTERFACE monthly individual session

ACTIVITY walking

STEP‐TRACKING pedometer (direct feedback)

RECORD diary: daily step count, symptoms

GOALS protocol‐driven (revised weekly)

  • < 6000 steps: increase of 3000 steps a day

  • ≥ 6000 to < 9000 steps: reach 9000 steps

  • > 9000 steps: maintain or increase steps

EDUCATION/RESOURCES nil

Outcomes

DEVICE Tanita PD724 (pedometer)

  • Wear instructions: 7 days (sticker covering display)

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks

PRIMARY OUTCOME

  • Physical activity: step count

SECONDARY OUTCOMES

  • HRQOL: SGRQ, CAT

  • Exercise capacity: 6MWD

  • Adherence: reported

  • Adverse events: not reported

  • Other: AECOPD

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Laura Mendoza [email protected] Hospital Clínico Universidad de Chile, Santiago (Chile)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The study was a parallel group, assessor‐blind, randomised controlled trial… Consecutive patients who consented to participate were randomly assigned to one of two groups…by the investigators based on a random number sequence generated in Excel (Microsoft, Redmond, WA, USA) before enrolment commenced"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention.

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "assessor‐blind…Assessments were performed by investigators blinded to treatment allocation…All assessments were made by technicians of the pulmonary function laboratory at Hospital Clínico Universidad de Chile, who were blinded to the allocation of the patients"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Unclear risk

Paper: anthropometrics, spirometry, dyspnoea, using data from the participant diaries, the incidence of (AECOPD)…was determined (additional outcomes reported)

Other bias

Low risk

N/A

Mitchell 2013

Methods

DESIGN 2 groups

DATES December 2009 to April 2012

SETTING 30 primary care COPD registers (UK)

SAMPLE SIZE calculation based on CRQ dyspnoea domain

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (FER < 0.7)

  • Clinically stable for 4 weeks

  • MRC dyspnoea scale (grade 2 to 5)

EXCLUSION CRITERIA

  • Unable to undertake an exercise regime due to neurological, musculoskeletal or cognitive comorbidities

  • Unable to read English to the reading age of an 8‐year‐old

  • PR within 12 months

BASELINE CHARACTERISTICS

  • INTERVENTION self‐management (SPACE) (n = 89, physical activity data n = 52)

AGE mean 69 (SD 8) years; SEX 54 (61%) male; FEV1 mean 56 (SD 17)% predicted

  • NO INTERVENTION (n = 95, physical activity data n = 65)

AGE mean 69 (SD 10) years; SEX 47 (50%) male; FEV1 mean 60 (SD 17)% predicted

Interventions

DURATION OF INTERVENTION 6 weeks

FOLLOW‐UP 6 months

SUPERVISION no

INTERVENTION self‐management (SPACE) (as in Kanabar 2015)

  • Initial 30‐ to 45‐minute consultation (physiotherapist)

    • Motivational interviewing techniques were used

      • explore the participants’ readiness to change

      • enhance motivation for adopting new lifestyle behaviours

      • Participants’ needs were discussed

      • goal‐setting strategies were introduced

    • advised how to use the manual at home

      • work through the manual in approximately 6 weeks

      • theirs to keep to use as a resource for the future and that the lifestyle changes it suggested should be lifelong.

    • exercise regime was described by the physiotherapist in detail

  • Week 2 and Week 4: telephone calls (physiotherapist)

    • reinforcing skills

    • providing encouragement to progress

  • 176‐page workbook (approved by the Plain English Campaign) individuals follow independently at home

    • sections on

      • disease education

      • stress management strategies

      • breathing control advice

      • techniques to improve exercise capacity and levels of domestic physical activity

      • individual action plan for exacerbation management

    • home exercise programme

      • daily walking programme

      • 3 times a week upper‐ and lower‐limb resistance training using free weights

      • advises on training progression

    • Acquisition of skills is promoted through

      • goal‐setting strategies

      • coping planning

      • case studies

NO INTERVENTION

Managed within primary care, no PR during the study period

Outcomes

DEVICE SenseWear armband (software version not reported)

  • Wear instructions: 7 days, waking hours

  • Data inclusion criteria: ≥ 4 days, ≥ 12 hours

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 6 weeks

  • Follow‐up: 6 months

PRIMARY OUTCOME

  • HRQOL: CRQ dyspnoea domain

SECONDARY OUTCOMES

  • Physical activity: step count, sedentary time (threshold not defined), time in physical activity (bouts of at least 10 minutes duration, > 3 METs), total EE

  • HRQOL: CRQ fatigue, emotion and mastery domains

  • Exercise capacity: ISWD, ESWT

  • Adherence: not reported

  • Adverse events: reported

  • Other: anxiety and depression, self‐efficacy for PR, smoking status, healthcare utilisation

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Sally Singh sally.singh@uhl‐tr.nhs.uk University Hospitals Of Leicester NHS Trust, Leicester (UK)

Additional data provided: group numbers

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Participants were assigned to either usual care or SPACE FOR COPD via a web‐based, concealed allocation programme, using simple randomisation codes prepared by the trial statistician"

Allocation concealment (selection bias)

Low risk

Quote: "concealed allocation programme"

Blinding of participants (performance bias)

High risk

Quote: "Lack of participant blinding may have increased motivation when receiving the treatment and attempts to satisfy the researchers might have increased the observed treatment effect in the intervention arm. We cannot, therefore, rule out the possible impact of attention"

Blinding of personnel (performance bias)

Unclear risk

Quote: "Randomisation was conducted by the trial investigator responsible for administering the intervention"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "assessments at 6 weeks and 6 months were conducted by a member of the research team who was blind to randomisation allocation"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

CONSORT diagram provided for all study participants but subgroup with physical activity data unclear

Selective reporting (reporting bias)

Unclear risk

SECONDARY OUTCOMES

Registry: task completion, adherence, exacerbation rates (not reported)

Other bias

Unclear risk

  • Retrospectively registered

  • Timing of motivational telephone calls

    • Registry: week 2, week 5, month 3, month 5

    • Paper: week 2, week 4

  • Duration of intervention

    • Registry: "It is anticipated that participants will have worked through the manual in approximately eight weeks"

    • Paper: 6 weeks

Moy 2015a

Methods

DESIGN 2 groups

DATES December 2011 to January 2013

SETTING Veterans identified from a national database (USA, Puerto Rico)

SAMPLE SIZE calculation based on SGRQ

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD, emphysema or chronic bronchitis (ICD‐9‐CM codes)

  • Age > 40 years

  • Able to walk at least 1 block

  • Sedentary (< 150 min of self‐reported physical activity a week)

  • Healthcare provider who can give medical clearance

  • Checks e‐mail weekly and access to a computer with an Internet connection, a USB port, Windows XP or Vista 7/8

  • Not involved in another pedometer‐based walking programme

EXCLUSION CRITERIA

  • Veterans from 1 of the 21 Veterans Integrated Service Networks, where another study using the 'Taking healthy steps' platform was recruiting participants

BASELINE CHARACTERISTICS

  • INTERVENTION: PAC (web‐based) with pedometer (n = 154)

AGE mean 67 (SD 9) years; SEX 146 (95%) male; FEV1 not assessed

  • INTERVENTION: pedometer (n = 84)

AGE mean 66 (SD 9) years; SEX 77 (92%) male; FEV1 not assessed

Interventions

DURATION OF INTERVENTION 12 months

FOLLOW‐UP no

SUPERVISION no

COMMON INTERVENTION pedometer

No instructions about exercise

INTERFACE website

ACTIVITY walking

STEP‐TRACKING pedometer (direct feedback)

RECORD website: step count at least monthly

GOALS, EDUCATION/RESOURCES nil

INTERVENTION PAC (web‐based, as in Wan 2017)

DURATION initial intensive 4‐month phase followed by an 8‐month maintenance phase

INTERFACE website

ACTIVITY walking

STEP‐TRACKING pedometer (direct feedback)

RECORD website: step count at least weekly

GOALS Website: display progress, protocol‐driven goal (revised weekly)

EDUCATION/RESOURCES website: education and motivational content, community forum

Outcomes

DEVICE Omron HJ‐720 ITC (pedometer)

  • Wear instructions:

    • baseline: 7 days (sticker covering display)

    • Months 4 and 12: feedback from pedometer during assessment period while they continued in the study.

  • data inclusion criteria: ≥ 5 days within 7 consecutive days, ≥ 100 steps, ≥ 8 hours a day)

    • Month 4: window of 14 days around day 121

    • Month 12: window of 14 days around day 366

  • data upload:

    • study staff mailed a pedometer with embedded USB port, upload cable

    • detailed written instructions on how to install the Java software and upload pedometer data

    • staff were available by telephone to assist with software installation and upload of step counts.

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 4 months

  • End intervention: 12 months

OUTCOMES

  • HRQOL: SGRQ

  • Physical activity: step count

  • Exercise capacity: not assessed

  • Adherence: reported

  • Adverse events: reported

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Caroline Richardson [email protected] University of Michigan (USA)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "A random sample of 28,957 veterans (one‐half urban, one‐half rural) were sent a recruitment letter… Group assignment was computer generated"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to intervention.

Blinding of personnel (performance bias)

High risk

Quote: "Masking: None (Open Label)"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

High risk

HRQOL:

Quote: "Masking: None (Open Label)"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Unclear risk

Paper: adherence, engagement, safety, dyspnoea (Methods: baseline, month 4, month 12; Results: baseline) (additional outcomes reported)

Other bias

Unclear risk

  • unclear impact on generalisability of results: "Interested participants completed an online questionnaire…checks e‐mail weekly; has access to a computer with an Internet connection, a USB port, and Windows XP, Vista, 7 or 8"

  • acknowledged limitations in Discussion

    • "We studied primarily white male Veterans limiting the generalizability of our results"

    • "We acknowledge the final response rate was likely biased toward responders who had a particular interest in this type of intervention, and the results may not be generalizable to a wider COPD population"

    • "Spirometric confirmation of the COPD diagnosis was not made at study entry. However, any potential misclassification of asthma as COPD was most likely balanced between groups and would not bias the primary results"

Nakamura 2016

Methods

DESIGN 2 groups

DATES not reported (abstract only)

SETTING multicentre (Japan)

SAMPLE SIZE not reported (abstract only)

Participants

INCLUSION CRITERIA

  • Moderate‐to‐severe COPD

  • Age ≥ 40 years

  • Outpatients

  • Controlled by COPD medications except long‐acting anticholinergic agents ≥ 4 weeks

EXCLUSION CRITERIA not reported

BASELINE CHARACTERISTICS not reported

  • INTERVENTION LAMA (aclidinium bromide) (n = 22)

  • INTERVENTION LAMA (tiotropium) (n = 22)

Interventions

DURATION OF INTERVENTION 8 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION LAMA (aclidinium bromide, 400 μg) twice daily

INTERVENTION LAMA (tiotropium, 18 μg) once daily

Outcomes

DEVICE GT3X‐BT (software version not reported)

  • Wear instructions, data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 8 weeks

PRIMARY OUTCOME

  • Other: spirometry

SECONDARY OUTCOMES

  • Physical activity: not defined

  • HRQOL: SGRQ

  • Exercise capacity: not assessed

  • Adherence: not reported

  • Adverse events: reported

  • Other: dyspnoea, AECOPD

Notes

FUNDING "This study was funded by Kyorin Pharmaceutical Co., Ltd. (UMIN000020020)"

CONFLICT OF INTEREST not reported (abstract only)

CONTACT not provided

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Randomized"

Comment: Insufficient information (abstract only)

Allocation concealment (selection bias)

Unclear risk

Not specified (abstract only)

Blinding of participants (performance bias)

High risk

Quote: "open‐label"

Blinding of personnel (performance bias)

High risk

Quote: "open‐label"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL:

Quote: "open‐label"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Appears that all randomised participants completed the study

Selective reporting (reporting bias)

High risk

No registry available; abstract only

No data presented that can be used for analysis; only between‐group P‐values provided

Other bias

Unclear risk

Abstract only

NCT00144326

Methods

DESIGN 2 groups, phase 3

DATES September 2003 to October 2005

SETTING Canada, Germany, Spain

SAMPLE SIZE not reported

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (FEV1 ≤ 65% predicted, FER < 0.7)

  • Smoking history (current or former) ≥ 10 pack‐years

  • Age ≥ 40 years

  • Able to inhale the medication by HandiHaler

EXCLUSION CRITERIA

  • Significant diseases other than COPD

  • Regularly use daytime oxygen therapy for > 1 hour a day and in investigator's opinion would be unable to abstain from oxygen therapy during study

  • Any respiratory tract infection within 6 weeks

  • History of asthma, allergic rhinitis or atopy

  • Total eosinophil count ≥ 600 mm3

BASELINE CHARACTERISTICS not reported

  • INTERVENTION LAMA (tiotropium bromide) (n = 123)

  • PLACEBO (n = 127, completed n = 125)

Interventions

DURATION OF INTERVENTION AND FOLLOW‐UP 12 weeks

SUPERVISION no

INTERVENTION LAMA (tiotropium bromide, 18 mcg) oral inhalation capsules, once daily in the morning with HandiHaler

PLACEBO oral inhalation capsules, once daily in the morning with HandiHaler

Outcomes

DEVICE Stayhealthy RT3 accelerometer

  • Wear instructions: 5 days (Thursday to Monday, closest to the corresponding visit)

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 1 month, 2 months

  • End intervention: 12 weeks

PRIMARY OUTCOME

  • Physical activity: VMU

SECONDARY OUTCOMES

  • Physical activity: time point at which 20% improvement from baseline physical activity was achieved

  • HRQOL: CRQ

  • Exercise capacity: 6MWD

  • Adverse events:

  • Also: spirometry, dyspnoea, rescue medication, Physician’s Global Assessment, vital signs, ECG, physical examinations

Notes

FUNDING Boehringer Ingelheim

CONFLICT OF INTEREST not stated

CONTACT not stated

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information

Allocation concealment (selection bias)

Unclear risk

Insufficient information

Blinding of participants (performance bias)

Unclear risk

Quote: "Double blind"

Comment: unclear to whom this refers

Blinding of personnel (performance bias)

Unclear risk

Quote: "Double blind"

Comment: unclear to whom this refers

Blinding of outcome assessment [objective] (detection bias)

Low risk

Objectively assessed physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

Quote: "Double blind"

Comment: unclear to whom this refers

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No participant flow chart

Selective reporting (reporting bias)

Unclear risk

No data presented suitable for meta‐analysis

Other bias

Unclear risk

No participant features reported

Not published in peer‐reviewed journal

NCT01351792

Methods

DESIGN 2 groups

DATES September 2011 to November 2012

SETTING 7 centres (The Netherlands)

SAMPLE SIZE not reported

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (moderate to severe; post‐bronchodilator FEV1 < 65% predicted, FER < 0.7, FEV1 reversibility < 15% and < 200 mL)

  • Smoking history (current or former) ≥ 10 pack‐years

  • Age ≥ 40 years

  • Regular bronchodilator use (2 months)

  • FRC > 120% predicted

  • Baseline Dyspnoea Index focal score ≤ 10

  • Ability to be trained in the proper use of inhalers

EXCLUSION CRITERIA

  • Diagnosis of asthma or other respiratory disorders

  • Pregnant or lactating women

  • Clinically‐unstable concurrent disease (e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease; gastrointestinal disease; neurological disease; haematological disease; autoimmune disorders)

  • Narrow‐angle glaucoma

  • Clinically‐significant laboratory and ECG abnormalities indicating a significant or unstable concomitant disease which may impact study results or participant safety

  • AECOPD requiring antibiotic therapy (≥ 5 days) within 2 months

  • Long‐term oxygen therapy for chronic hypoxemia (> 12 hours daily) or chronic mechanical ventilation for COPD

  • Treated with corticosteroids within 2 months

  • Known allergy, sensitivity or intolerance to sympathomimetic drugs or inhaled corticosteroids or to any of the excipients contained in study drugs

  • Evidence of alcohol or drug abuse, not compliant with the study protocol according to investigator judgement

  • Major surgery within 3 months that may affect compliance with study procedures

  • Participation in another clinical trial with an investigational drug within 2 months

BASELINE CHARACTERISTICS not reported

  • INTERVENTION (n = 31, completed n = 30)

  • PLACEBO (n = 29, completed n = 29)

Interventions

DURATION OF INTERVENTION 4‐week run‐in phase, 12 week intervention

FOLLOW‐UP no

SUPERVISION no

COMMON RUN‐IN PHASE 4 weeks, Symbicort (200/6 µg/unit dose) 1 inhalation twice a day

INTERVENTION Foster (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations twice a day
INTERVENTION Symbicort (budesonide 200 μg plus formoterol fumarate 6 μg/actuation)

Outcomes

DEVICE pedometer

ASSESSMENT TIME POINTS

  • Initial

  • Baseline: end 4‐week run‐in phase

  • End intervention: 12 weeks

PRIMARY OUTCOME

  • HRQOL: “reduction of symptoms, improvements in health status (assessed by specific questionnaires)”

  • Adverse events:

  • Also: residual volume

SECONDARY OUTCOME

  • Physical activity: step count

  • HRQOL: CCQ

  • Also: body plethysmography, impulse oscillometry, symptom‐free days, rescue medication use, AECOPD, nasal brushing

Notes

FUNDING Chiesi Farmaceutici Parma (Italy)

CONFLICT OF INTEREST

CONTACT Chiesi Farmaceutici [email protected]

Eddi Bindi [email protected] Gabriele Nicolini [email protected]

Marteen van den Berge [email protected]

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: “randomised”

Comment: insufficient information

Allocation concealment (selection bias)

Unclear risk

Insufficient information

Blinding of participants (performance bias)

Low risk

Quadruple (participant, care provider, investigator, outcomes assessor) (NCT)

Blinding of personnel (performance bias)

Low risk

Quadruple (participant, care provider, investigator, outcomes assessor) (NCT)

Blinding of outcome assessment [objective] (detection bias)

Low risk

Quadruple (participant, care provider, investigator, outcomes assessor) (NCT)

Blinding of outcome assessment [other] (detection bias)

Low risk

Quadruple (participant, care provider, investigator, outcomes assessor) (NCT)

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

EUCTR: target size n = 170

NCT: target size n = 130, actual recruitment n = 113

Study report: randomised Foster n = 31, symbicort n = 29

Selective reporting (reporting bias)

High risk

Results not published in peer‐reviewed journal; only data available are from study report

Other bias

Unclear risk

Prospectively registered

Quote: “prematurely ended; low number of evaluable patients (which was less than half of the planned number)”

Ng 2015

Methods

DESIGN cross‐over trial (only pre‐cross‐over data used), 2 groups

DATES not reported (abstract only)

SETTING PR (country?)

SAMPLE SIZE not reported (abstract only)

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD

  • 6MWD ≤ 450 metres pre‐PR

  • Prescribed a wheeled walker by a physiotherapist for use during PR

EXCLUSION CRITERIA not reported

BASELINE CHARACTERISTICS (total n = 19)

AGE mean 72 (SD 8) years; SEX 11 (58%) males; FEV1 mean 38 (SD 19)% predicted

  • INTERVENTION four‐wheeled walker (n = 8)

  • NO INTERVENTION (n = 10)

Interventions

DURATION OF INTERVENTION AND FOLLOW‐UP 4 weeks (only pre‐cross‐over data)

FOLLOW‐UP no

SUPERVISION no

INTERVENTION four‐wheeled walker

Outcomes

DEVICE StepWatch

  • Wear instructions: ≥ 3 days

  • Data inclusion criteria: not reported

  • ActivPAL results provided by author, not presented in abstract or poster

ASSESSMENT TIME POINTS

  • Pre‐cross‐over: 4 weeks

PRIMARY OUTCOME

  • Physical activity: step count

SECONDARY OUTCOMES

  • HRQOL: CRQ

  • Exercise capacity: not assessed

  • Adherence: not reported

  • Other: distance walked, self‐reported barriers

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Kylie Hill [email protected] Cindy Ng [email protected] Curtin University, Perth (Australia)

Additional information provided: CRQ, physical activity pre‐cross‐over data

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "randomly allocated"

Comment: Insufficient information

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL: not specified

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not specified

    • Group 1 data for 8 participants

    • Group 2 data for 10 participants (9 for activPAL data without four‐wheeled walker in phase 1)

Selective reporting (reporting bias)

Unclear risk

ActivPAL results provided in author correspondence but not presented otherwise

Other bias

Unclear risk

No baseline assessment

Nguyen 2009

Methods

DESIGN 2 groups

DATES October 2006 to April 2008

SETTING PR programmes

SAMPLE SIZE feasibility study; no power calculation

Participants

INCLUSION CRITERIA

  • Stable COPD (GOLD criteria: FER < 0.7, FEV1 < 80% predicted)

  • Age ≥ 40 years

  • Completed PR prior to intervention (some variability in timing of commencement noted: "The goal was to approach interested participants during the final 2–3 weeks of their PR program in order to allow a two‐week run‐in period; however, due to scheduling challenges, some participants did not start their run‐in until they completed PR)"

  • No plans to participate in a maintenance programme

  • Receiving supplemental oxygen if SpO2 > 88% on < 6 litres a minute of nasal oxygen during 6MWT

  • Ability to speak, read, and write English

  • Permission from health provider

EXCLUSION CRITERIA

  • Active symptomatic illness (e.g. cancer, heart failure, ischaemic heart disease, neuromuscular disease, psychiatric illness)

  • Unable (e.g. severe arthritis) or unwilling to use the study‐issued cell phone

  • Reside outside of the wireless coverage area

BASELINE CHARACTERISTICS

  • INTERVENTION PAC (coached, app) with pedometer (n = 9)

AGE mean 72 (SD 9) years; SEX 3 (33%) male; FEV1 mean 47 (SD 19)% predicted

  • INTERVENTION PAC (self‐managed, app) with pedometer (n = 8)

AGE mean 64 (SD 12) years; SEX 3 (38%) male; FEV1 mean 34 (SD 15)% predicted

Interventions

DURATION OF INTERVENTION 6 months

FOLLOW‐UP no

SUPERVISION no

INTERVENTION PAC (coached, app)

INTERFACE

  • 1 individual session

  • text messages

  • phone calls prn

  • automatic alerts sent to nurse if “marked” symptoms for 2 days

ACTIVITY Individual home exercise programme (as in exercise test performance, dyspnoea, community‐based facilities, preferred mode)

STEP‐TRACKING pedometer (direct feedback)

RECORD daily symptoms and exercise log via phone, transmitted real‐time to central server

GOALS

  • moderate‐intensity endurance exercise, 3 to 5 sessions a week, up to 150 minutes, upper‐ and lower‐limb resistance exercises

  • instant text feedback with weekly summary

  • weekly short‐text messages from the nurse based on submitted data

EDUCATION/RESOURCES

  • COPD exacacerbation signs and symptoms, self‐care strategies, exercise adjustment

  • exacerbation action plan: liaise with health provider

  • booklet: exercise tips, local resources

INTERVENTION PAC (self‐managed, app)

INTERFACE

  • weekly standard text message

  • no symptom alert

ACTIVITY individual home exercise programme (as in exercise test performance, dyspnoea, community‐based facilities, preferred mode)

STEP‐TRACKING pedometer (direct feedback)

RECORD daily symptoms and exercise log by phone

GOALS

  • moderate‐intensity endurance exercise, 3 to 5 sessions a week, up to 150 minutes, upper‐ and lower‐limb resistance exercises

  • daily automatic calendar reminder to log data

EDUCATION/RESOURCES

  • COPD exacacerbation signs and symptoms, self‐care strategies, exercise adjustment

  • exacerbation action plan: liaise with health provider

  • booklet: exercise tips, local resources

Outcomes

DEVICE Stepwatch 3 (right ankle)

  • Wear instructions: 14 days, waking hours

  • Data inclusion criteria: ≥ 10 hours

ASSESSMENT TIME POINTS

  • Baseline

  • Mid intervention: 12 weeks

  • End intervention: six months

OUTCOMES

  • Physical activity: step count, % time inactive (waking hours), % MVPA time, peak performance

  • HRQOL: SGRQ, SF36

  • Exercise capacity: peak work rate (cycle ergometry), 6MWD (N.B. results expressed in feet; converted to metres for data entry)

  • Adherence: reported

  • Adverse events: reported

  • Other: technical issues, usability and acceptability, self‐efficacy for exercise

Notes

FUNDING reported "Omron Healthcare donated the pedometers"

CONFLICT OF INTEREST statement provided

CONTACT Huong Nguyen [email protected] University of Washington, Seattle (USA)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "A biostatistician who was not involved in the day‐to‐day study operations generated the randomization sequence"

Allocation concealment (selection bias)

Low risk

Quote: "A biostatistician who was not involved in the day‐to‐day study operations…placed the randomization in separate sealed opaque envelopes"

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention.

Blinding of personnel (performance bias)

Unclear risk

Quote: "the interventionist was not blind to group assignment"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity and exercise capacity (cycle ergometry)

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity (6MWD):

Quote: "the outcome assessments were performed by a research assistant who was blinded"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

High risk

PRIMARY OUTCOME

Registry: exercise behaviour (not defined)

Paper: autonomous self‐regulation for exercise (additional outcome)

SECONDARY OUTCOMES

Registry: AECOPD (not reported)

Paper: technical issues, beliefs and attitudes towards exercise and self care, validation of self‐reported exercise, intervention time and costs (additional outcomes)

Other bias

High risk

  • "Since this was a feasibility study, we did not conduct an a priori power calculation…sample of 20 participants based on a realistic projection of the available pulmonary rehabilitation graduate pool who would be willing to participate in the study over the limited recruitment time frame"

  • inconsistent start times: "Patient graduates from four PR programs who successfully completed a two‐week run‐in period were randomized ...The goal was to approach interested participants during the final 2–3 weeks of their pulmonary rehabilitation program in order to allow a two‐week run‐in period; however, due to scheduling challenges, some participants did not start their run‐in until they completed pulmonary rehabilitation"

  • provision of training pre‐randomisation potentially able to influence subsequent intervention: "Participants completed a two‐week run‐in period in order to determine their ability to adhere to the exercise and symptom self‐monitoring protocol. They were trained on entering data via the cell phone... asked to provide a return demonstration, and were given a step‐by‐step help booklet with screenshots of the cell phone displays... Participants who submitted at least 80% of exercise and symptom data during the run‐in and chose to proceed with the study were scheduled for baseline testing"

  • excludes rural participants: "reside outside of the wireless coverage area"

Nolan 2017

Methods

DESIGN 2 groups

DATES July 2012 to June 2014

SETTING hospital PR unit (UK)

SAMPLE SIZE calculation based on time in moderate‐intensity physical activity

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD criteria)

  • Age ≥ 35 years

  • modified MRC dyspnoea scale (grade 2 or higher)

  • Consented to supervised PR

EXCLUSION CRITERIA

  • Contraindications to exercise (e.g. significant cardiovascular comorbidities)

  • Participants choosing community PR site without access to specialist exercise equipment

BASELINE CHARACTERISTICS

  • INTERVENTION PAC with PR (n = 76)

AGE mean 68 (SD 9) years; SEX 56 (74%) male; FEV1 mean 51 (SD 21)% predicted

  • INTERVENTION PR (n = 76)

AGE mean 68 (SD 8) years; SEX 54 (71%) male; FEV1 mean 51 (SD 22)% predicted

Interventions

DURATION OF INTERVENTION 6 months

FOLLOW‐UP no

SUPERVISION no

INTERVENTION PR

DURATION 8 weeks

SETTING outpatient group

CONTACT 2 sessions a week (15 minutes warm‐up, 60 minutes exercise, 45 minutes education)

AEROBIC TRAINING walking, aim 15 minutes continuously, Borg scale dyspnoea (rating 3 to 4)

  • INITIAL PRESCRIPTION 80% baseline ISWT predicted peak oxygen consumption

STRENGTH TRAINING upper and lower limbs (2 sets, 10 repetitions)

  • INITIAL PRESCRIPTION 60% 1RM

OTHER COMPONENTS at least once a week, home‐based exercise session

EDUCATION

  • Multidisciplinary team presentations: physical activity and exercise, medication use, diet, smoking cessation, coping strategies, managing infections through early recognition, rescue medication, appropriate general practice/hospital presentation

  • booklet

INTERVENTION PAC (in‐person)

INTERFACE 8 individual sessions (weekly during PR)

ACTIVITY walking

STEP‐TRACKING pedometer (direct feedback)

RECORD diary: daily step count

GOALS

  • during PR: protocol‐driven increase by 5%

  • following PR: 20% increase from initial

EDUCATION/RESOURCES nil

Outcomes

DEVICE SenseWear (Software version not reported) and Yamax DigiWalker CW700 (pedometer)

  • Wear instructions: 7 days

  • Data inclusion criteria: ≥ 5 days, ≥ 22.5 hours

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 8 weeks (end PR)

  • End intervention: 6 months

PRIMARY OUTCOME

  • Physical activity: MVPA time (≥ 3 METs)

SECONDARY OUTCOMES

  • Physical activity: step count (pedometer and SenseWear), sedentary time (< 1.5 METs), LIPA time (1.5 to 2.99 METs)

  • HRQOL: CRQ

  • Exercise capacity: ISWD

  • Adherence: PR component not reported

  • Adverse events: reported

  • Other: spirometry

Notes

FUNDING reported

CONFLICT OF INTERESTstatement provided

CONTACT Claire Nolan [email protected] Imperial College, London (UK)

Additional information provided: confirmed distribution of variables precluding inclusion in meta‐analysis

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "parallel, two‐group, assessor‐blinded randomized controlled trial… following baseline assessment, participants were randomly allocated 1:1 to… the allocation sequence was computer generated and accessed by a researcher independent of (study processes)"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Quote: "It was not possible to conceal group allocation from participants"

Blinding of personnel (performance bias)

Low risk

Quote: "The clinical team delivering the PR program were blinded to the participants' group allocation"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "assessors blinded to group allocation"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Unclear risk

SECONDARY OUTCOMES
Registry: SF36 (not reported)

Paper: accelerometer and pedometer step counts, adverse events, hospitalisations and deaths (additional outcomes)

Other bias

Low risk

N/A

O'Neill 2018

Methods

DESIGN 2 groups

DATES February 2014 to January 2016

SETTING PR within 2 Health and Social Care Trusts (Northern Ireland)

SAMPLE SIZE "this study will inform a future large scale RCT"

Participants

INCLUSION CRITERIA (registry)

  • Primary diagnosis of COPD

  • Stable phase (not on antibiotics, deemed clinically stable by the clinical team)

  • Referred to PR

  • Good understanding of written English (as reported by the individual participant)

EXCLUSION CRITERIA (registry)

  • Inability to safely take part in a walking programme or PR (e.g. unstable angina, neurological, spinal or skeletal dysfunction affecting ability to exercise)

  • Inability to comprehend or follow instructions (e.g. dementia)

  • Clinically unstable (AECOPD or any change in symptoms and medication within 4 weeks)

BASELINE CHARACTERISTICS

  • PHYSICAL ACTIVITY INTERVENTION (n = 23, completed)

AGE mean 61 (SD 9); SEX 13 (57%) male; FEV1 mean 54 (SD 23)% predicted

  • PULMONARY REHABILITATION (n = 26, completed)

AGE mean 67 (SD 8); SEX 11 (42%) male; FEV1 mean 57 (SD 24)% predicted

Interventions

DURATION OF INTERVENTION PAC 12 weeks, PR 6 weeks

FOLLOW‐UP no

SUPERVISION yes

COMMON INTERVENTION

participants given the Living Well With COPD for PR booklet

INTERVENTION physical activity intervention

DURATION 12 weeks

INTERFACE weekly contact with the physiotherapist or nurse

  • Weeks 1 to 6: in‐person

  • Weeks 7 to 11: telephone

  • Week 12: in‐person

  • In‐person consultations: up to 1 hour in outpatient hospital department

  • Telephone consultations: 15 – 20 minutes at an agreed time

  • Session content

    • Revised daily steps of the previous week

    • reviewed the step goal (met/not met/partially met)

    • Identify barriers to physical activity and strategies to overcome these

    • Specific strategies to increase walking were identified

    • Action and coping plans led by participant

ACTIVITY walking

STEP‐TRACKING unsealed Yamax Digiwalker CW700 pedometers each day for motivation and feedback

RECORD manual with weekly step diary

GOALS COM‐B model of behaviour change (capability, opportunity, motivation, behaviour)

  • Outcome goal relating to an activity or function set at baseline

    • reviewed during the intervention

    • Week 6: if it was already met or participants felt it was too difficult, it was revised or amended

    • reviewed at the end to determine whether it was achieved

  • Step count goal revised weekly and set by participants based on

    • previous week step count

    • results of a ‘self‐efficacy walk’ (number of steps in 10 minutes)

EDUCATION/RESOURCES during consultations clinicians focused on helping participants to build self‐efficacy, encouraging social support, providing disease‐specific education

INTERVENTION pulmonary rehabilitation

DURATION 6 weeks

SETTING hospital or health‐centre outpatient departments

CONTACT 2 x week, also given a booklet with exercises and encouraged to perform these independently on a third occasion

AEROBIC TRAINING exercise component usually lasted for 1 hour, generally consisted of cardiovascular exercises

STRENGTH TRAINING lower‐ and upper‐body strengthening exercises

OTHER COMPONENTS A diary was used to record the exercises undertaken and the level of breathlessness measured with the BORG scale

EDUCATION centre‐based disease‐specific education, at which time participants could engage in discussion and ask questions at least once weekly (30 – 60 minutes)

Outcomes

DEVICE ActigraphVR GT3X accelerometer, sealed Yamax Digiwalker CW700 pedometer

worn around the waist for 7 days during all waking hours

Only Actigraph data that contained a minimum of 5 days of 10 hours wear‐time were used for analysis

Only sealed pedometer data that had a minimum of 5 days of 100 – 50,000 steps were used for analysis

ASSESSMENT TIME POINTS

4 study visits for outcome assessment

  • baseline assessment: 2 appointments 7 days apart (Visits 1 and 2)

  • post‐intervention (Visit 3)

  • 3 months following the end of the intervention (Visit 4)

PRIMARY OUTCOME / SECONDARY OUTCOMES

  • physical activity: step count

  • exercise capacity : ISWT

  • HRQoL: CAT, EQ5D‐5L

  • adherence: number of sessions attended, set at 75%

  • adverse events

  • Also: IPAQ, modified Global Rating of Change, semi‐structured interviews, feasibility and fidelity

Notes

FUNDING "The study was funded by the Northern Ireland Chest Heart and Stroke (NICHS). PhD student (O’Shea O) was funded by the Department of Employment and Learning. The study was sponsored by the Ulster University and the Western and Belfast Health and Social Care Trusts. The study was supported by the Northern Ireland Clinical Research Network (NICRN) Respiratory Health interest group."

CONFLICT OF INTEREST "The authors have no conflicts of interest to declare."

CONTACT Brenda O'Neill [email protected] Ulster University, Newtownabbey (UK)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Participants were randomly assigned to two groups using computer‐generated block random numbers by a member of team not involved in any other aspect of the study in order to ensure allocation concealment"

Allocation concealment (selection bias)

Low risk

Quote: "The allocation was retained in sealed envelopes which were opened to reveal group allocation only after consent and after the completion of baseline assessment"

Blinding of participants (performance bias)

High risk

Unable to blind participants to intervention

Blinding of personnel (performance bias)

Unclear risk

Insufficient information

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

Quote: "All data was collected by a trained independent assessor not involved in the delivery of either intervention; a physiotherapist and/or a research assistant"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: Participants’ flow through the study is shown in Figure 1.

Quote: "The patients were assessed and randomised to the PAI (n = 24) or PR (n = 26). One participant who was randomised to the PAI made a mistake and attended PR. Therefore, n = 27 attended PR and n = 23 attended the PAI. A further n = 1 participant randomised to PR was excluded from the analysis as subsequent information about their diagnosis revealed that the person did not meet the GOLD criteria for COPD; therefore, n = 49 have been included in the analysis: n = 23 PAI; n = 26 PR."

Selective reporting (reporting bias)

Unclear risk

Results reported as in Methods, apart from time points for assessment where follow‐up data not presented

Other bias

Unclear risk

Retrospectively registered

Ogasawara 2018

Methods

DESIGN 2 groups

DATES November 2014 to October 2017

SETTING single centre (Japan)

SAMPLE SIZE calculation based on lean body mass index

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD criteria)

  • Hospitalised for AECOPD or pneumonia

  • Planned for PR during the hospitalisation

  • Able to eat and drink safely without dysphagia

EXCLUSION CRITERIA

  • History of severe drug allergy

  • Took oral nutritional supplements during the trial (? per protocol analysis)

  • Inadequate to receive additional nutrition therapy (uncontrolled diabetes or dyslipidemia, or both)

  • Refuse PR

BASELINE CHARACTERISTICS

  • INTERVENTION nutritional supplement (with eicosapentaenoic acid) with PR (n = 24)

AGE mean 77 (SD 10) years; SEX 21 (88%) male; FEV1 mean 64 (SD 25)% predicted

  • INTERVENTION nutritional supplement (without eicosapentaenoic acid) with PR (n = 21)

AGE mean 79 (7) years; SEX 20 (95%) male; FEV1 mean 68 (SD 35)% predicted

Interventions

DURATION OF INTERVENTION hospital length of stay

FOLLOW‐UP no

SUPERVISION yes

COMMON INTERVENTION

  • Medical management

    • broad‐spectrum antibiotic: choice and duration as per supervising physician

    • inhaled nebulised, short‐acting bronchodilator 4 times a day

    • orticosteroid therapy: dosage and duration as per supervising physicians

  • PR

    • 20 to 30 minutes a day

    • "patient‐tailored training programs": exercise training, conditioning, education on breathing methods

INTERVENTION nutritional supplement with eicosapentaenoic acid (ProSure) 1 pack or can a day

INTERVENTION nutritional supplement without eicosapentaenoic acid (ENSURE®) 1 pack or can a day

Outcomes

DEVICE pedometer (HJA‐401F, Omron) step length measured as 0.37 * height (cm) (input for device)

  • Wear instructions: during hospitalisation

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • "physical activity was assessed once a week and at hospital discharge"

PRIMARY OUTCOME

  • Also: antropometric measures

SECONDARY OUTCOMES

  • Physical activity: step count, TEE

  • HRQoL: CAT

  • Also: BMI, mMRC, plasma and serum levels

Notes

FUNDING "This study did not receive any specific grant from funding agencies in the public, commercial, or not‐for‐profit sectors"

CONFLICT OF INTEREST "None of the authors declared a conflict of interest"

CONTACT Takashi Ogasawara [email protected] Hamamatsu Medical Centre, Shizuoka (Japan)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomization was performed using a computer‐generated randomization scheme with blocks of four"

Allocation concealment (selection bias)

Unclear risk

Insufficient information

Blinding of participants (performance bias)

High risk

Quote: "open‐label"

Blinding of personnel (performance bias)

High risk

Quote: "open‐label"

Blinding of outcome assessment [objective] (detection bias)

Unclear risk

Quote: "open‐label"

Blinding of outcome assessment [other] (detection bias)

High risk

Quote: "open‐label"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT figure provided

Quote: "In total, 50 eligible patients were enrolled in the study and evaluated prospectively (Fig. 1). One patient in the EPA group was excluded, because his body weight at the time of admission was erroneously input to the BIA, resulting in the BMI and LBMI being characterized as overweight. Three patients in the control group were also excluded because they could not continue taking ONS orally due to dysphagia or intubation, and one patient withdrew informed consent"

Selective reporting (reporting bias)

Low risk

Registry and paper in agreement

Other bias

Unclear risk

Prospectively registered

Unable to access supplementary data:

Quote: "Data not available / The authors do not have permission to share data"

Orme 2018

Methods

DESIGN 3 groups (3 comparisons)

  • feedback with education vs. education

  • education vs. no intervention

  • feedback with education vs. no intervention

DATES February to June 2016

SETTING hospital (UK)

SAMPLE SIZE "The study will aim to recruit as many patients as are admitted to hospital for an acute COPD exacerbation within the operational period. One of the main objectives of this feasibility study is to provide data on eligibility and recruitment and to enable an accurate estimation of the required sample size for a future trial based on a realistic recruitment plan."

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD ("confirmed")

  • Age 40 to 85 years

  • < 4 AECOPD requiring hospital admission within 12 months

  • Confirmed AECOPD as the reason for current hospitalisation

  • Physically able to participate in LIPA (i.e. walking with an aid)

EXCLUSION CRITERIA

  • Considered unsuitable (e.g. severe mental impairment, terminally ill)

  • Injury or additional health condition that precludes their ability to take part in LIPA

  • Overlying medical disorder that interferes with provision of consent, completion of measurements, intervention, interview or follow‐up

  • Taking part in concomitant research studies

BASELINE CHARACTERISTICS

AGE mean 71 (SD 20) years; SEX 10 (30%) male; FEV1 not reported

  • INTERVENTION education with feedback (n = 12, completed n = 8)

  • INTERVENTION education (n = 10, completed n = 3)

  • NO INTERVENTION (n = 11, completed n = 6)

Interventions

DURATION OF INTERVENTION 2 weeks following discharge from hospital

FOLLOW‐UP no

SUPERVISION no

INTERVENTION feedback

INTERFACE

  • 1 individual session

  • App and LUMO posture sensor worn on the lower back (in contact with skin)

ACTIVITY break up sedentary bouts

STEP‐TRACKING inclinometer (direct haptic feedback: sedentary time > threshold)

RECORD inclinometer sends data to app

GOALS app: step count, sitting, standing, lying down, sit‐to‐stand transitions

INTERVENTION education

EDUCATION/RESOURCES verbal and written information: booklet Sit Less, Move More, Live Healthier adapted for COPD

Outcomes

DEVICE ActiGraph wGT3X‐BT (version 6.13.2; firmware 1.6.1) (waistband on the right anterior axillary line)

  • wear instructions: 2 weeks, waking hours (remove for water‐based activities)

  • data inclusion criteria: ≥ 4 valid days for each of the 2 weeks, ≥ 8 hours a day

  • NB unique detail of accelerometry data collection and analytical procedures in appendix

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: Day 15

PRIMARY OUTCOME

  • Feasibility and acceptability

SECONDARY OUTCOMES

  • Physical activity: step count, "stationary" time (< 100 cpm), LIPA time (100 to 2019 cpm), MVPA time (≥ 2020 cpm)

  • HRQOL: CAT

  • Exercise capacity: not assessed

  • Adherence: reported

  • Adverse events: reported

  • Other: dyspnoea, fatigue, anxiety and depression, attendance at pulmonary rehabilitation, falls, self‐reported sitting time

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Mark Orme mark.orme@uhl‐tr.nhs.uk University Hospitals Of Leicester NHS Trust, Leicester (UK)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Block randomization was conducted... by an individual independent of the research team"

Allocation concealment (selection bias)

Unclear risk

Quote: "sequentially numbered sealed envelopes ... balanced combinations of group allocations within blocks will be conducted by a researcher at Loughborough University who is independent of the research team. This will ensure study team researchers will be blinded to group allocation prior to patients deciding whether to take part in the study. Owing to limited study team members and logistical barriers, study team researchers will be made aware of group allocation before consent. Patients will only be informed of their group allocation after providing informed consent"

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

High risk

HRQOL:

Quote: "researchers will not be blinded to treatment allocation for qualitative interviews and study measurements"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

High risk

Registry: 20 metre gait analysis using foot‐worn inertial sensors (not reported)

Registry and protocol: EQ5D, grip strength (not reported)

Protocol:

  • International Physical Activity questionnaire (not reported)

  • Marshall Sitting Time Survey (only reported at baseline)

Paper: PR attendance, information on the ownership and usage of computers and smartphones, index of multiple deprivation (additional outcomes reported)

Other bias

High risk

No physical activity data available per group

Registry: changes made on 31 May 2016 (following completion of recruitment)

  • Originally: "The intervention period will be 28 days following hospital discharge"

    • changed to 14 days

  • Originally: "Patient outcomes are assessed at a follow‐up appointment 4 weeks after commencement of the intervention"

    • changed to2 weeks

  • additional secondary outcome measure: Falls Efficacy Scale

  • revised target number of participants

    • originally "45 to 60 (15 to 20 in each arm)"

    • changed to "as many as possible as this is a feasibility study"

Polkey 2018

Methods

DESIGN 2 groups

DATES December 2015 to August 2016

SETTING hospital (China)

SAMPLE SIZE "In the absence of pilot data, a formal power calculation was not possible"

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD II to IV: post‐bronchodilator FEV1 ≥ 25% to < 80% predicted, post‐bronchodilator FER < 0.7)

  • Age 40 to 80 years

  • Bronchodilator naïve patients

  • Residents in Xingning city (Guangdong Province, China)

EXCLUSION CRITERIA

  • Currently or previous Tai Chi or PR

  • Malignancy of any organ system treated or untreated within 5 years

  • Clinically significant renal, cardiovascular, neurological, metabolism, immunological, psychiatric, gastrointestinal, hepatic, or haematological abnormalities

  • Concomitant pulmonary disease e.g. asthma, lung fibrosis, primary bronchiectasis, sarcoidosis, interstitial lung disorder, tuberculosis

  • BMI > 40 kg/m2

  • LTOT (greater than 12 hours a day)

  • AECOPD within 6 weeks

BASELINE CHARACTERISTICS

  • INTERVENTION Tai Chi (n = 60, completed n = 55)

AGE, SEX not reported; FEV1 post‐bronchodilator mean 49 (SD 13)% predicted

  • INTERVENTION PR (n = 60, completed n = 55)

AGE, SEX not reported; FEV1 post‐bronchodilator mean 47 (SD 15)% predicted

Interventions

DURATION OF INTERVENTION 2 weeks indacaterol, 12 weeks indacaterol and intervention

FOLLOW‐UP 12 weeks indacaterol

SUPERVISION yes

INTERVENTION Tai Chi

DURATION 12 weeks

SETTING "big exercise hall"

CONTACT 5 sessions a week, 1 hour

TRAINING Yang style

  • 24 consecutive movements in a section

    • 6 minutes (5 minutes movement, 1 minute's rest)

    • Repeated 10 times (1 hour)

    • Written materials and a CD

  • Initial 2 weeks: group (2 to 3 participants), 2 to 3 movements each day until 24 movements were ‘mastered’

  • Subsequent larger group training: single instructor provided instructions relayed to all group members in the hall by real‐time video streaming using 2 giant screens

  • After completion, encouraged to continue (alone or community group)

  • Exercise did not become more strenuous over the training period: "when receiving individual tuition it is possible to progressively increase the difficulty of the movements by increasing the duration that the patient stands on one leg or lowering the centre of gravity this was not possible for us to provide, except in a general sense, in a group class"

OTHER COMPONENTS LABA (indacaterol, 150 ug per day)

EDUCATION "educational input"

INTERVENTION PR

DURATION 12 weeks

SETTING supervised, outpatient, group

CONTACT 3 sessions a week, 1 hour

AEROBIC TRAINING 50%

  • treadmill

    • INITIAL PRESCRIPTION 2 minutes at “usual pace”

    • PROGRESSION 1 km a minute

  • stepper

    • INITIAL PRESCRIPTION as for treadmill, 25 repetitions each leg, repeated twice

    • PROGRESSION increase the number of repetitions or resistance, or both

  • upright static bicycle and elliptical trainer

    • INITIAL PRESCRIPTION 6 minutes, 50 cycles a minute

    • PROGRESSION "in collaboration with the subject"

  • rowing machine

    • INITIAL PRESCRIPTION 6 minutes, 20 rows a minute

    • PROGRESSION "resistance was progressively increased", Borg scale rating of perceived dyspnoea (rating 4 to 6)

  • if no observed ventilatory limitation, targets 60% to 80% maximum heart rate

STRENGTH TRAINING 50% shoulder abduction, bicep curls, sit to stand, lunge walks with dumbbells

    • INITIAL PRESCRIPTION 70% to 80% 1RM (2 sets, 10 repetitions)

    • PROGRESSION increase the number of repetitions and or resistance or both

OTHER COMPONENTS LABA (indacaterol, 150 ug per day)

EDUCATION "educational sessions"

Outcomes

DEVICE ActiGraph

  • Wear instructions: 7 days

  • Data inclusion criteria: not reported

  • No details re data handling for mid‐intervention assessment

ASSESSMENT TIME POINTS

  • METHODS

    • Screening (visit 1)

    • End intervention: week 14 (visit 6)

    • Follow‐up: week 26 (visit 9)

  • RESULTS

    • Baseline (visit 2)

    • Mid‐intervention: week 6? (visit 4) N.B. during exercise training

    • Follow‐up: week 22 (visit 8)

PRIMARY OUTCOME

  • HRQOL: SGRQ (Visits 2, 3, 6, 9)

SECONDARY OUTCOMES (visits 2, 3, 6, 9)

  • Physical activity: step count (N.B. Week 11 was the last week of intervention)

  • Exercise capacity: 6MWD

  • Adherence: LABA component not documented

  • Adverse events: reported

  • Other: spirometry, body composition, dyspnoea, physical function, muscle strength, hospital admission or emergency department attendance

Notes

FUNDING "The study was in part funded by Novartis China as an investigator‐initiated trial; the State Key Laboratory of Respiratory Disease (Guangzhou Medical University) was the sponsor. The study drug (indacaterol) was provided by Novartis China. Both the Key State Laboratory (Guangzhou) and the NIHR Respiratory Biomedical Unit provided in‐kind support, the latter through partial salary support of M. I. P. Space for the study was made available by the governors of Xing‐Ning People’s Hospital. Y.M. L. was also partially supported by the National Key Research and Development Program of China (Project No. 2016YFC1304200)."

CONFLICT OF INTEREST "Financial/nonfinancial disclosures: None declared. Role of sponsors: Novartis China had no role in writing the manuscript or the decision to publish."

CONTACT Yuan‐Ming Luo [email protected] State Key Laboratory of Respiratory Disease, Guangzhou (China)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Allocation: Randomized"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to exercise intervention

Blinding of personnel (performance bias)

High risk

Quote: "None (Open Label)"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

High risk

HRQOL and exercise capacity:

Quote: "None (Open Label)"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

High risk

PRIMARY OUTCOME

Registry: only specified primary outcomes

  • SGRQ at Visit 6 (following 2 weeks indacaterol and 12 weeks training)

Paper: SGRQ at Visits 2, 3, 6, 9

SECONDARY OUTCOMES not specified in registry

Paper:

  • methods for assessment of physical activity

    • Visit 1 (screening) pre‐intervention

    • Visit 6 (starting 11 weeks after starting training) end exercise training

    • Visit 9 (starting 11 weeks after finishing training) end follow‐up

  • results for physical activity

    • Visit 2 pre‐intervention

    • Visit 4 mid‐intervention (e‐fig 1 indicates this would be after 4 weeks of training)

    • Visit 8 4 weeks before Visit 9 (e‐fig 1 indicates this would be after 8 weeks of follow‐up)

Other bias

Unclear risk

  • "In the absence of pilot data, a formal power calculation was not possible" (disputed in letter to the editor)

  • No details about age or sex of participants

  • PR group “conventional exercise 5 days per week” (registry), "three times per week" (paper)

  • Physical activity assessed at Visit 4 was during exercise training; no information regarding handling of physical activity data ("seven days of monitoring") and unclear if days of training are included

Priori 2017

Methods

DESIGN 2 groups

DATES, SETTING, SAMPLE SIZE not reported (abstract only)

Participants

INCLUSION/EXCLUSION CRITERIA not reported

BASELINE CHARACTERISTICS (n = 21)

  • INTERVENTION PAC (n = 10 completed)

AGE mean 70 (SD 8) years; SEX not reported; FEV1 mean 44 (SD 14)% predicted

  • NO INTERVENTION (n = 8 completed)

AGE mean 68 (SD 5) years; SEX not reported; FEV1 mean 43 (SD 12)% predicted

Interventions

DURATION OF INTERVENTION 8 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION PAC (automated coaching)

INTERFACE automated coaching messages

GOALS "weekly goals, daily feedback"

ACTIVITY, STEP‐TRACKING, RECORD, EDUCATION/RESOURCES nil

NO INTERVENTION"blinded to their physical activity"

Outcomes

DEVICE DirectLife (activity monitor)

  • Wear instructions, data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • End intervention: 8 weeks

PRIMARY OUTCOME

  • Physical activity: time in moderate‐intensity physical activity ("ActivePoints", threshold not defined)

SECONDARY OUTCOMES

  • HRQOL: not assessed

  • Exercise capacity: not assessed

  • Adverse events: not reported

  • Adherence: not reported

Notes

FUNDING, CONFLICT OF INTEREST not reported (abstract only)

7 co‐authors on this abstract are employed by Philips (as in Saini abstract) also no disclaimer re Philips (funded as in Saini abstract?)

CONTACT Rita Priori [email protected] Phillips (The Netherlands)

Additional information provided: confirmed this is a stand‐alone study

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "patients were randomized"

Comment: Insufficient information (abstract only)

Allocation concealment (selection bias)

Unclear risk

Not specified (abstract only)

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified (abstract only)

Blinding of outcome assessment [objective] (detection bias)

Unclear risk

Physical activity: unclear if participant reported

Blinding of outcome assessment [other] (detection bias)

Low risk

N/A

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Quote: "21 patients were recruited… Ten IG… and 8 CG…patients completed the study"

Comment: Insufficient information (abstract only)

Selective reporting (reporting bias)

Unclear risk

Insufficient information (abstract only)

Other bias

Unclear risk

Abstract only

Probst 2011

Methods

DESIGN 2 groups

DATES July 2006 to July 2009

SETTING University Hospital, Universidade Estadual de Londrina, Londrina, Parana (Brazil)

SAMPLE SIZE post hoc power calculation… time spent in activities of intensity > 3 METs

Participants

INCLUSION CRITERIA

  • COPD diagnosis (GOLD criteria)

  • Stable condition (no AECOPD or infections within 3 months)

  • Able to attend the outpatient clinic 3 times a week

EXCLUSION CRITERIA

  • Severe or unstable cardiac disease (e.g. left‐ventricular failure, atrial fibrillation)

  • Comorbidities that may limit tests, exercise training

  • PR within 1 year

MEDICATIONS "Pharmacologic treatment was not changed during the course of the study"

BASELINE CHARACTERISTICS (n = 63)

  • INTERVENTION exercise training (calisthenics and breathing exercises) (n = 19 completed)

AGE mean 65 (SD 10) years; SEX 11 (58%) male; FEV1 mean 39 (SD 14)% predicted

  • INTERVENTION exercise training (endurance and strength training) (n = 20 completed)

AGE mean 67 (SD 7) years; SEX 10 (50%) male; FEV1 mean 40 (SD 13)% predicted

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION exercise training (calisthenics and breathing exercises)

DURATION 12 weeks

SETTING outpatient group

CONTACT 3 sessions a week, 1 hour

STRENGTH TRAINING

  • 5 sets of exercises; each set consisted of 12 different exercises, repeated 15 times each

    • breathing exercises (diaphragmatic breathing and pursed‐lips breathing)

    • strengthening of abdominal muscles (crunches)

    • calisthenics (trunk rotation and flexion, associated with pursed lips breathing and prolonged expiration)

  • performed in supine, side‐lying, sitting, kneeling, standing

  • new set after every 7 sessions

  • intensity was increased in each new set by a progression in difficulty

AEROBIC TRAINING, OTHER COMPONENTS, EDUCATION nil

INTERVENTION exercise training (endurance and strength training)

DURATION 12 weeks

SETTING outpatient group

CONTACT 3 sessions a week, 1 hour

AEROBIC TRAINING

  • INITIAL PRESCRIPTION cycling ergometry 60% of baseline maximum work rate

  • INITIAL PRESCRIPTION treadmill 75% of baseline 6MWT average speed

  • PROGRESSION weekly, work rate or duration, Borg scale dyspnoea and fatigue (rating 4 to 6)

STRENGTH TRAINING quadriceps, biceps, triceps

  • INITIAL PRESCRIPTION 70% 1RM

  • PROGRESSION weekly, work rate or duration, Borg scale dyspnoea and fatigue (rating 4 to 6)

OTHER COMPONENTS, EDUCATION nil

Outcomes

DEVICE

DynaPort Activity Monitor (waist): time walking, standing, sitting, and lying

SenseWear (upper‐posterior region of the right arm): step count, MVPA time, energy expenditure

  • Wear instructions: 2 weekdays (Tuesday and Wednesday) over 2 weeks, 12 hours a day

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks

PRIMARY OUTCOME

  • Physical activity: step count, time walking, standing, sitting, and lying, MVPA time (> 3 METs), active EE (> 3 METs), total EE

SECONDARY OUTCOMES

  • HRQOL: SGRQ

  • Exercise capacity: 6MWD, peak work rate and endurance time (cycle ergometry)

  • Adherence: reported

  • Adverse events: not reported

  • Other: spirometry, dyspnoea, body composition, muscle force, functional status

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Fabio Pitta [email protected] Universidade Estadual de Londrina, Parana (Brazil)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "randomized trial"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

Unclear risk

Not specified

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity and exercise capacity (cycle ergometry)

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity (6MWD): not specified

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No participant flow diagram

Group numbers prior to dropout not stated

Selective reporting (reporting bias)

Unclear risk

No trial registry; results presented as in Methods (other than results for respiratory muscle force after intervention)

Other bias

Unclear risk

Post hoc power calculation identified in study limitations in Discussion

Rinaldo 2017

Methods

DESIGN 2 groups

DATES January 2013 to January 2014, followed up until November 2014

SETTING Fitness Centre of the Exercise and Sport Science School of Verona University (Italy)

SAMPLE SIZE calculation based on 6MWD

Participants

INCLUSION CRITERIA

  • Mild‐to‐severe COPD

  • Age > 60 years

  • Male sex

  • Clinically stable

  • No PR within 1 year

EXCLUSION CRITERIA

Unstable cardiac disease, pneumonia, pulmonary embolism, pulmonary vascular disease, respiratory infections, lung cancer, thoracic malignancy, and bone fractures

BASELINE CHARACTERISTICS

  • INTERVENTION exercise training with tapered supervision (n = 14)

AGE mean 66 (SD 5) years; SEX 100% male; FEV1 mean 72 (SD 19)% predicted

  • INTERVENTION supervised exercise training (n = 14)

AGE mean 66 (SD 4) years; SEX 100% male; FEV1 mean 60 (SD 24)% predicted

Interventions

DURATION OF INTERVENTION 28 weeks

FOLLOW‐UP 14 weeks

SUPERVISION no

INTERVENTION exercise training with tapered supervision

physical activity education programme approach, based on a periodically supervised protocol of different exercise modalities

DURATION 28 weeks

SETTING outpatient group

CONTACT 60 minutes

  • Weeks 1 to 5: supervised 3 sessions per week

  • Weeks 6 to 10: supervised 2 sessions, self‐directed 1 session a week

  • Weeks 10 to 14: supervised 1 session, self‐directed 2 sessions a week

  • Weeks 15 to 28: self‐directed 3 sessions a week

AEROBIC/STRENGTH TRAINING

  • aerobics classes with flexibility and balance exercises: modified Borg scale (rating 3 to 4)

  • music‐based weight‐free exercises: 1 set, 8 repetitions, training recovery ratio as 1 : 2 or 1 : 3

  • Nordic walking: 10 to 20 minutes at self‐selected speeds, modified Borg scale perceived exertion (rating 3 to 4)

  • weight‐free exercises: 10 to 15 repetitions, 2 to 4 circuits, 4 minutes recovery between circuits

OTHER COMPONENTS nil

EDUCATION "Participants also received brochures with information about the local physical activity facilities"

INTERVENTION supervised exercise training

training protocol was in line with published recommendations

"The participants self‐monitored the intensity and duration of endurance and resistance exercises to avoid exertional dyspnoea"

DURATION 28 weeks

SETTING outpatient group

CONTACT 3 times a week, 1 hour

AEROBIC TRAINING cycling, treadmill walking or upper limb ergometer

  • 30 minutes, modified Borg scale perceived exertion (rating 3 to 4)

STRENGTH TRAINING upper limb, lower limb, trunk; 4 sets

  • INITIAL PRESCRIPTION 50% to 80% 1RM

  • PROGRSSION every 3 to 4 weeks

OTHER COMPONENTS flexibility and balance exercises

EDUCATION "All participants were instructed to continue with their prescribed exercise program during the 14‐week follow‐up period."

Outcomes

DEVICE SenseWear (software version not reported)

  • Wear instructions: 48 hours

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 28 weeks

  • Follow‐up: 14 weeks

PRIMARY OUTCOME

  • Exercise capacity: 6MWD (assumed as used for sample size calculation)

SECONDARY OUTCOMES

  • Physical activity: total EE

  • HRQOL: Maugeri Respiratory Failure questionnaire

  • Adherence: reported

  • Adverse events: not reported

  • Other: spirometry, body composition, muscle strength, flexibility, balance

Notes

FUNDING "The authors received no financial support."

CONFLICT OF INTEREST "The authors have no conflict to declare."

CONTACT Giuseppe Coratella [email protected] University of Verona (Italy)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "a restricted block (size = 4) randomization, generated by free online software (www.randomization.com) was used to allocate the participants within the 2 groups"

Allocation concealment (selection bias)

Unclear risk

Quote: "allocation and randomization were completed by one of the researchers without any contact or knowledge of the participants…. Thus, no allocation concealment mechanisms were necessary"

Blinding of participants (performance bias)

Unclear risk

Not specified

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity: not specified

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Low risk

No trial registry; results presented as in Methods

Other bias

Unclear risk

only male participants

Saini 2017

Methods

DATES, SETTING, SAMPLE SIZE not reported (abstract only)

Participants

INCLUSION CRITERIA COPD patients
EXCLUSION CRITERIA not reported

BASELINE CHARACTERISTICS (TOTAL n = 28)

AGE mean 64 (SD 7) years; SEX 15 (54%) males; FEV1 not reported

Interventions

DURATION OF INTERVENTION 8 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION online physical activity coaching system designed to support maintenance of physical activity at home after PR

NO INTERVENTION

Outcomes

DEVICE Philips DirectLife activity monitor

  • Wear instructions: "entire period"

ASSESSMENT TIME POINTS

  • Baseline: pre‐PR waiting period

  • PR: 8 to 16 weeks of inpatient and outpatient PR

  • End intervention: 8 weeks following PR completion

PRIMARY OUTCOME

  • Physical activity: time in moderate‐intensity physical activity

SECONDARY OUTCOME

  • Exercise capacity: 6MWD

Notes

FUNDING This abstract is funded by Philips

CONFLICT OF INTEREST None stated

CONTACT Privender Saini [email protected] Phillips (The Netherlands)

NB. Abstract states that this study is ongoing

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information

Allocation concealment (selection bias)

Unclear risk

Insufficient information

Blinding of participants (performance bias)

Unclear risk

Insufficient information

Blinding of personnel (performance bias)

Unclear risk

Insufficient information

Blinding of outcome assessment [objective] (detection bias)

Unclear risk

Insufficient information

Blinding of outcome assessment [other] (detection bias)

Unclear risk

Insufficient information

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient information

Selective reporting (reporting bias)

Unclear risk

Insufficient information

Other bias

Unclear risk

This abstract is funded by Philips

Sandland 2008

Methods

DESIGN 2 groups

DATES not reported

SETTING hospital PR department (UK)

SAMPLE SIZE calculation based on arbitrary activity counts

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (FEV1 < 50% predicted)

  • Clinically stable

  • MRC dyspnoea scale (grade 3 or greater)

  • No longer smoking

  • Hypoxic at rest, receiving LTOT or demonstrated exercise‐induced desaturation (arterial oxygen desaturation > 4% below 90% on a standard walking test)

  • Completed 7‐week PR prior to the study

EXCLUSION CRITERIA not reported

BASELINE CHARACTERISTICS

  • INTERVENTION supplemental oxygen (n = 10)

AGE mean 71 (SD 4) years; SEX 6 (60%) male; FEV1 mean 43 (SD 16)% predicted

  • PLACEBO air (n = 10)

AGE mean 76 (SD 8) years; SEX 8 (80%) male; FEV1 mean 44 (SD 29)% predicted

Interventions

DURATION OF INTERVENTION 8 weeks

FOLLOW‐UP no

SUPERVISION no

COMMON INTERVENTION 2 litres a minute through nasal cannula

backpack

no limit on cylinder usage

standard advice

  • how to use the cylinders at home

  • diary cards to self‐report cylinder usage and time spent away from home for 7 days for 8 weeks

  • encouraged to use the cylinder while performing activities of daily living and walking outside the house

  • investigator visited the participants at home on a regular basis to change cylinders and to help with compliance

INTERVENTION supplemental oxygen

PLACEBO air

Outcomes

DEVICE Z80 32K VI (waist)

  • Wear instructions: 7 consecutive days, 12 hours each day from 9:00 to 21:00

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 8 weeks

OUTCOMES

  • Physical activity: domestic activity counts (arbitrary units)

  • HRQOL: CRQ, SF36

  • Exercise capacity: ISWD, ESWT

  • Adherence: reported

  • Adverse events: reported

Notes

FUNDING ACKNOWLEDGMENT: "The authors acknowledge Air Products for the supply of cylinders."

CONFLICT OF INTEREST statement provided

CONTACT Carolyn Sandland carolyn.sandland@uhl‐tr.nhs.uk University Hospitals Of Leicester NHS Trust, Leicester (UK)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "patients were randomized to receive cylinder oxygen or cylinder air for 8 weeks. Prior to the study, a randomization list was prepared"

Allocation concealment (selection bias)

Unclear risk

Quote: "prior to the study, a randomization list was prepared and transferred to sealed envelopes"

Blinding of participants (performance bias)

Low risk

Quote: "double‐blinded… the cylinders were prefllIed with oxygen or air and were disguised and only identifiable by a colour code"

Blinding of personnel (performance bias)

Low risk

Quote: "double‐blinded… the cylinders were prefllIed with oxygen or air and were disguised and only identifiable by a colour code"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity: not specified

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

no participant flow diagram by group provided

Selective reporting (reporting bias)

Unclear risk

Results as in Methods except SF36 results not presented other than "there were no significant changes in the SF36"

Other bias

Unclear risk

Trial registration: National Research Register N0123109178. Unable to access

Schuz 2015

Methods

DESIGN 2 groups

DATES May 2008 to December 2010

SETTING 31 general practices in rural, remote and metropolitan areas (Australia)

SAMPLE SIZE calculation based on SF36

Participants

INCLUSION CRITERIA

  • COPD (or being treated with tiotropium for COPD, post‐bronchodilator FER < 0.7)

  • Age > 45 years

  • Smoking history > 10 pack‐years

EXCLUSION CRITERIA

  • Lack of English literacy

  • Mental or physical incapacity

  • End‐stage cancer

  • Residency in a nursing home

BASELINE CHARACTERISTICS

AGE mean 68 (SD 8) years; SEX 97 (53%) male; FEV1 mean 55 (SD 13)% predicted

  • INTERVENTION self‐management (health mentoring) (Month 4 n = 55, Month 6 n = 73)

  • SHAM (Month 4 n = 83, Month 6 n = 47)

Interventions

DURATION OF INTERVENTION 12 months

FOLLOW‐UP no

SUPERVISION no

INTERVENTION self‐management (health mentoring)

Up to 16 phone calls, trained community nurses

  • Core components to support self‐management (psycho‐education, self‐management skills, cognitive coping skills, communication skills, self‐efficacy)

  • Medium‐ to long‐term goals targeting physical activity uptake, smoking cessation, nutrition, alcohol consumption, psychosocial well‐being, symptom management

SHAM

Usual care as provided by GP

Monthly “social” phone calls without specific advice or skills training

Outcomes

DEVICE ActiGraph GT1M

  • wear instructions: 7 days, waking hours

  • data inclusion criteria: ≥ 3 days, ≥ 10 hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 6 months

  • End intervention: 12 months

OUTCOMES

  • Physical activity: step count

  • HRQOL: SGRQ, SF36

  • Exercise capacity: not assessed

  • Adherence: reported

  • Adverse events: reported

  • Other: self‐efficacy for managing chronic disease, depression, life satisfaction, data on hospital admissions related to COPD

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Julia Walters [email protected] University of Tasmania, Hobart (Australia)

Additional data provided: step count, HRQOL

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "cluster randomized controlled trial… Participating practices were randomised using a code generated from a random numbers table"

Allocation concealment (selection bias)

Low risk

Quote: "concealment of allocation was provided by sequentially numbered opaque, sealed envelopes"

Blinding of participants (performance bias)

Unclear risk

Quote: "randomisation occurred at general practice level to avoid contamination between the intervention and control groups"

Blinding of personnel (performance bias)

Unclear risk

Quote: "randomisation occurred at general practice level to avoid contamination between the intervention and control groups"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL:

Quote: "blinded assessor"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

High risk

Registry (not in paper)

  • Step count (6 and 12 months post cessation)

  • Hospital Anxiety and Depression Scale (6 and 12 months post cessation)

  • Spirometry after baseline

  • Healthcare utilisation measured by general practice routine and urgent attendances, emergency department visits for COPD

  • Client satisfaction questionnaire, qualitative assessment of health‐mentoring using semi‐structured interviews

Other bias

Low risk

N/A

Sena 2013

Methods

DESIGN 2 groups

DATES, SETTING, SAMPLE SIZE not reported (abstract only)

Participants

INCLUSION CRITERIA

  • Severe COPD

  • Male sex

  • No recent AECOPD

EXCLUSION CRITERIA

  • Exercise contraindicated

BASELINE CHARACTERISTICS not reported

  • INTERVENTION exercise training (eccentric cycle training) (n = 8)

  • INTERVENTION exercise training (concentric cycle training) (n = 8)

Interventions

DURATION OF INTERVENTION 10 weeks

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION exercise training (eccentric cycle training)

SETTING outpatient

CONTACT 3 sessions a week

AEROBIC TRAINING high‐intensity: target 4 times 80% baseline concentric maximal work capacity

STRENGTH TRAINING, OTHER COMPONENTS, EDUCATION nil

INTERVENTION exercise training (concentric cycle training)

SETTING outpatient

CONTACT 3 sessions a week

AEROBIC TRAINING high‐intensity: target 80% baseline concentric maximal work capacity

STRENGTH TRAINING, OTHER COMPONENTS, EDUCATION nil

Outcomes

DEVICE SenseWear Pro3 (software version not reported)

  • Wear instructions, data inclusion criteria: not reported

TIME POINTS

  • Baseline

  • Programme completion: 10 weeks

OUTCOMES

  • Physical activity: "physical activity levels"

  • HRQOL: not assessed

  • Exercise capacity: peak work rate (cycle ergometry)

  • Adherence: not reported

  • Adverse events: not reported

  • Other: spirometry, muscle strength

Notes

FUNDING reported

CONFLICT OF INTEREST statement not provided (abstract only)

CONTACT Riany Sena [email protected] McGill University Health Center, Montreal (Canada)

Additional information provided: type of device, risk of bias assessment

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomization was performed by an investigator not involved in the study with variable block design (maximum size of 4) with equal allocation ratio (1:1), using a computer‐generated sequence (http://www.randomizer.org)" (correspondence)

Allocation concealment (selection bias)

Low risk

Quote: "The allocation sequence was placed in double‐sealed opaque envelopes. The trainer opened the appropriate envelope only once the baseline evaluation had been completed" (correspondence)

Blinding of participants (performance bias)

Unclear risk

Quote: "Given the kind of intervention, a blinded design was not possible for patients... (but) patients were unaware of our primary outcome... patients allotted to the (eccentric training) group exercised at a different time than did the patients in the (concentric training) group and were asked not to discuss their exercises with assessors and their peers" (correspondence)

Blinding of personnel (performance bias)

Unclear risk

Quote: "Given the kind of intervention, a blinded design was not possible for patients and trainers... however, trainers were not involved in the data collection" (correspondence)

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity, exercise capacity

Blinding of outcome assessment [other] (detection bias)

Low risk

N/A

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "We had a total of 4 dropouts. There were 11 participants in the eccentric group and 13 participants in the concentric group, but 10 participants in each group completed all the training sessions. For the final study, we did intention to treat analyses and included all 24 participants" (correspondence)

Selective reporting (reporting bias)

Unclear risk

Insufficient information (abstract only)

Other bias

Unclear risk

Abstract only

Singh 1998

Methods

DESIGN 2 groups

DATES not reported (abstract only)

SETTING PR programme (UK)

SAMPLE SIZE not reported (abstract only)

Participants

INCLUSION CRITERIA

  • Stable COPD

  • In PR

EXCLUSION CRITERIA not reported

BASELINE CHARACTERISTICS

  • INTERVENTION unaware of purpose of pedometer during PR (n = 9)

AGE mean 67 (SD 10) years; SEX 7 (78%) males; FEV1 mean 1.2 (SD 0.3) litres

  • INTERVENTION aware of purpose of pedometer during PR (n = 10)

AGE mean 71 (SD 9) years; SEX 8 (80%) males; FEV1 mean 1.1 (SD 0.4) litres

Interventions

DURATION OF INTERVENTION 1 week

FOLLOW‐UP no

SUPERVISION no

INTERVENTION PR

SETTING outpatient group

INTERVENTION unaware of purpose of pedometer, no knowledge of the true purpose of the activity monitor

INTERVENTION aware of purpose of pedometer, full knowledge of the purpose of the activity monitor

Outcomes

DEVICE Gaewiler Electronic (waist)

  • Wear instructions: 7 consecutive days

  • Data inclusion criteria: 12 hours a day

ASSESSMENT TIME POINTS daily for 7 days

OUTCOMES

  • Physical activity: step count

  • HRQOL: not assessed

  • Exercise capacity: not assessed

  • Adherence: not reported

  • Adverse events: not reported

Notes

FUNDING, CONFLECT OF INTEREST not reported (abstract only)

CONTACT Sally Singh sally.singh@uhl‐tr.nhs.uk University Hospitals Of Leicester NHS Trust, Leicester (UK)

Additional information requested.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Patients were randomised into two groups"

Comment: Insufficient information (abstract only)

Allocation concealment (selection bias)

Unclear risk

Not specified (abstract only)

Blinding of participants (performance bias)

Unclear risk

Quote: "Patients were randomised into two groups; Group 1, no knowledge of the true purpose of the activity monitor… group 2, full knowledge of the purpose of the activity monitor"

Blinding of personnel (performance bias)

Unclear risk

Not specified (abstract only)

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

N/A

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not specified (abstract only)

Selective reporting (reporting bias)

Unclear risk

Insufficient information (abstract only)

Other bias

Unclear risk

Abstract only

Steele 2019

Methods

DESIGN 2 groups

DATES 2009 to 2012

SETTING VA Puget Sound Health Care System, Seattle (USA)

SAMPLE SIZE calculation based on step count

Participants

INCLUSION CRITERIA

  • Optimally‐managed severe COPD (FEV1 <50% predicted) or heart failure (ejection fraction < 40%)

  • Working phone

  • Hospitalisation for heart failure, COPD or related illness within 2 years or ≥ 2 unscheduled outpatient visits for same within 1 year

EXCLUSION CRITERIA

  • Unstable disease or recent surgery that precluded exercise

  • Supplemental oxygen requirement > 4 litres a minute (at rest)

  • Already exercising 3 times a week

  • Inability to ambulate

  • Uncontrolled mental illness, alcohol or drug abuse

  • Life expectancy < 1 year

  • INTERVENTION adherence Intervention (n = 32)

AGE mean 67 (SD 10) years; SEX 100% male; FEV1 mean 32 (SD 14) % predicted

  • INTERVENTION PR (n = 31)

AGE mean 67 (SD 9) years; SEX 100% male; FEV1 mean 32 (SD 10)% predicted

N.B. group numbers at 6 months not provided

Interventions

DURATION OF INTERVENTION 8 weeks PR, 6 months adherence intervention

FOLLOW‐UP yes

SUPERVISION no

COMMON INTERVENTION exercise sessions

SETTING outpatient

AEROBIC AND STRENGTH TRAINING goal: treadmill walking 20 minutes

  • INITIAL PRESCRIPTION number of minutes and type of aerobic activity individually prescribed based on baseline 6MWD

5 minutes warm‐up: upper‐ and lower‐extremity stretching

20 minutes NuStep Borg scale (rating 4 to 6)

5 minutes free arm weights

5 minutes arm ergometry

5 minutes cool‐down: upper‐ and lower‐extremity stretching

INTERVENTION adherence intervention

  • Stage 1

DURATION 4 weeks

SETTING outpatient

CONTACT 4 hours

CONTENT exercise and integrated self‐management education, home safety evaluation

  • Stage 2

DURATION 3 months

SETTING home‐based

CONTACT 1 phone call a week

CONTENT

    • goal: walk 3 sessions a week, 30 minutes

    • diary: step count, walking sessions

    • self‐monitor: symptoms

  • Stage 3

DURATION 2 months

SETTING home‐based

CONTACT 1 phone call a fortnight

CONTENT as per stage 2

  • Stages 2 and 3

SETTING outpatient

CONTACT 1 session per month

CONTENT supervised exercise session

INTERVENTION PR

DURATION 8 weeks

CONTACT 2 hours

CONTENT exercise and self‐management instruction

Following the 8‐week programme

  • given a pedometer to track steps per day

  • encouraged to walk 3 sessions a week for 30 minutes

Outcomes

DEVICE Stepwatch Activity Monitor (Orthocare Innovations, LLC, Mountlake Terrace, WA) (above dominant ankle)

  • Wear instructions: not reported

  • Data inclusion criteria: ≥ 5 consecutive days (including weekdays and weekend days), ≥ 10 hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 6 months (end of adherence intervention)

  • Follow‐up: 12 months

PRIMARY OUTCOME

  • Physical activity: step count, peak performance (short walking bursts obtained by ranking all minutes of the day and averaging the highest 30 values), % time spent ambulating at low intensity (0 – 30 steps a minute)

  • Exercise capacity: 6MWD

SECONDARY OUTCOMES

  • Adherence: not reported

  • Adverse events: "An independent data and safety monitoring board provided oversight of the procedures, protocol, and events"

  • HRQoL: CCQ, SF36

  • Also: Geriatric Depression Scale, cardiopulmonary function

Notes

FUNDING VA HSR&D, NRI 04–242

CONFLICT OF INTEREST "The authors declare no conflicts of interest"

CONTACT Cynthia Dougherty [email protected] University of Washington, Seattle (USA)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "randomized … using a computerized adaptive treatment assignment algorithm"

Allocation concealment (selection bias)

Unclear risk

Insufficient information

Blinding of participants (performance bias)

High risk

Quote: "Masking: none (open label)"

Blinding of personnel (performance bias)

High risk

Quote: "Masking: none (open label)"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

Quote: "Post‐program measures were completed... by a team member blinded to group assignment"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

CONSORT diagram provided

No details about attrition according to diagnosis group

Selective reporting (reporting bias)

Unclear risk

Primary outcomes

Registry: 6MWD

Paper: 6MWD and physical activity

Secondary outcomes

Registry: SF36 PCS

Paper: SF36 PCS and MCS, clinical COPD questionnaire, Geriatric Depression Scale, cardiopulmonary function outcomes

12‐month outcomes not presented according to group allocation

Other bias

Unclear risk

Prospectively registered

First Posted: April 30, 2007

Study Start Date: December 2007

Actual Primary Completion Date: December 2011

May 2007;

Quote: "Improvement in functional capability, quality of life, self‐efficacy, cardiopulmonary function, gait & balance, mediating effects of self‐regulation model on functional capability, reduction in hospital admissions, outpatient visits & expenditures"

August 30, 2010; Enrolment: 200; Revised to 82

February 7, 2012; Enrolment: 100

August 30, 2017; Enrolment: 90

Tabak 2014a

Methods

DESIGN 2 groups

DATES October 2010 to April 2011

SETTING "recruited by a chest physician or nurse practitioner" (The Netherlands)

SAMPLE SIZE feasibility (limited availability of activity coach)

Participants

INCLUSION CRITERIA

  • No infection or AECOPD within 4 weeks

  • Current or former smoker

  • Able to read and speak Dutch

  • Internet access at home

EXCLUSION CRITERIA

  • Impaired hand function causing inability to use the application

  • Disorders or progressive disease seriously influencing daily activities (e.g. amputation)

  • Other diseases influencing bronchial symptoms or lung function (e.g. sarcoidosis), or both

  • Need for regular oxygen therapy (> 16 hours a day or pO2 < 7.2 kPa)

  • History of asthma

  • Started training with a physiotherapist within 6 weeks

BASELINE CHARACTERISTICS

  • INTERVENTION PAC with optional supervised exercise (n = 18, completed n = 14)

AGE mean 65 (SD 9) years; SEX 8 (44%) male; FEV1 mean 49 (SD 17)% predicted

  • INTERVENTION optional supervised exercise (n = 16)

AGE mean 68 (SD 6) years; SEX 11 (67%) male; FEV1 mean 56 (SD 11)% predicted

Interventions

DURATION OF INTERVENTION 3 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION PAC (telerehabilitation)

INTERFACE

  • Smartphone

  • Text messages

  • Website

ACTIVITY "Try to be active in such a way during the day that the displayed reference line is closely approached"

STEP‐TRACKING Accelerometer (MTx‐W sensor)

RECORD

  • Inclinometer sends data to smartphone

  • Website: daily symptoms*

GOALS

  • Smartphone: cumulative graph

  • Feedback text messages (summary and advice)

  • Website: Overview of measured activity levels

EDUCATION/RESOURCES

  • 2 self‐management sessions: AECOPD signs and symptoms, self‐care strategies

  • Decision‐support system: advice in case of AECOPD

INTERVENTION optional supervised exercise

SETTING optional, weekly, group sessions, local physiotherapy practices

Outcomes

DEVICE Yamax Digiwalker 200 (pedometer)

  • Wear instructions: continuous

  • Data inclusion criteria: ≥ 50% of day

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 3 weeks

PRIMARY OUTCOME

  • Physical activity: step count

SECONDARY OUTCOMES

  • HRQOL: CCQ

  • Exercise capacity: not assessed

  • Adherence: reported

  • Adverse events: not reported

  • Other: dyspnoea, fatigue

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Monique Tabak [email protected] Roessingh Research and Development, Roessinghsbleekweg (The Netherlands)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "participants were randomly assigned…according to a computer‐generated randomization list"

Allocation concealment (selection bias)

Low risk

Quote: "participants were allocated in order of inclusion following the randomization list. Recruitment, randomization, and allocation were performed by different persons"

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Unclear risk

Physical activity: unclear if step count was reported by participants

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL: not specified

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

High risk

SECONDARY OUTCOMES

Registry: distribution of activities throughout the day, correlation between pedometer and MTX‐W motion sensor (not reported)

Paper: CCQ, dyspnoea, fatigue, number of visits to the web portal, time the activity sensor was worn, adherence (additional outcomes)

Other bias

Unclear risk

Physiotherapy‐supervised exercise training in both groups: participation only described at baseline

Tabak 2014b

Methods

DESIGN 2 groups

DATES December 2011 to July 2013

SETTING Medisch Spectrum Twente Hospital and primary care physiotherapy practices, Enschede (The Netherlands)

SAMPLE SIZE

Registry: n = 30

Paper: “sample size was based upon the estimated number of patients that could be included within the recruitment period and the availability of technology”

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD; post‐bronchodilator FEV1 25% to 80% predicted)

  • Age > 40 years

  • No AECOPD within 1 month

  • ≥ 3 AECOPD or 1 hospitalisation for respiratory problems within 2 years

  • (Ex‐) smoker

  • Able to understand and read Dutch

  • Internet access at home

EXCLUSION CRITERIA (registry)

  • Serious other disease with a low survival rate

  • Other diseases influencing bronchial symptoms or lung function (e.g. cardiac insuficiency, sarcoidosis), or both

  • Severe psychiatric illness

  • Uncontrolled diabetes mellitus during AECOPD in the past or a hospitalisation for diabetes mellitus within 2 years

  • Need for regular oxygen therapy (> 16 hours a day or pO2 < 7.2 kPa)

  • Maintenance therapy with antibiotics

  • Known alpha1‐antitrypsine deficiency

  • Disorders or progressive disease seriously influencing daily activities (e.g. amputation, paralysis, progressive muscle disease)

  • Impaired hand function causing inability to use application

BASELINE CHARACTERISTICS

  • INTERVENTION (n = 12, completed n = 10)

AGE mean 64 (SD 9) years; SEX 6 (50%) male; FEV1 median 50 (IQR 33 to 62)% predicted

  • NO INTERVENTION (n = 12, completed n = 2)

AGE mean 63 (SD 7) years; SEX 6 (50%) male; FEV1 median 36 (IQR 26 to 54)% predicted

Interventions

DURATION OF INTERVENTION 9 months

FOLLOW‐UP no

SUPERVISION no

INTERVENTION “Condition Coach” technology‐supported care programme

Pre‐program: 2 90‐minute self‐management teaching sessions given by a nurse practitioner

  • how to complete daily diary

  • early recognition of AECOPD and starting standardised treatment

  • In the case of AECOPD, standardised intervention was initiated: prednisolone 30 mg for 7 days, and when indicated in combination with antibiotics (amoxicillin/clavulanic acid) 3 times daily for a period of 7 days or (in the case of hypersensitivity) doxycycline 100 mg for a period of 10 days

  • instructed to call study office if assistance required; if needed, consultation with chest physician or nurse practitioner scheduled

4 modules

1. Web‐based exercise programme: breathing exercises, relaxation, mobilisation, resistance and endurance training, mucus clearance created by physiotherapist; every exercise has description and movie care professionals could check progress on the web portal

2. Accelerometer‐based activity sensor and smartphone ambulant activity registration and display, real‐time feedback; goal: reference activity line

motivational cues

3. Web‐based self‐management module: participants to treat exacerbations themselves; decision‐support system that automatically formed advice to start medication if worsening clinical condition

4. Teleconsultation module for communication with primary care physiotherapist

NO INTERVENTION

in case of impending AECOPD, contact medical doctor

allowed to attend regular physiotherapy sessions if prescribed as part of usual care

Outcomes

DEVICE accelerometer‐based activity sensor (Inertia Technology, Enschede, The Netherlands)

  • Wear instructions: not reported

  • Data inclusion criteria: ≥ 6 hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 1 month, 3 months, 6 months

  • End intervention: 9 months

PRIMARY OUTCOMES

  • Adherence: diary, exercise

  • Also: app and care satisfaction

SECONDARY OUTCOMES

  • Physical activity: counts per minute

  • HRQOL: EQ5D, CCQ

  • Exercise capacity: 6MWD

  • Adverse events: not reported

  • Also: exacerbations, subjective physical activity, symptoms

Notes

FUNDING “Financial support was provided by the NL Agency, a division of the Dutch Ministry of Economic Affairs (grant CALLOP9089).”

CONFLICT OF INTEREST “The authors report no conflicts of interest in this work.”

CONTACT Monique Tabak [email protected] University of Twente, Drienerlolaan (The Netherlands)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: “Patients were randomized using a computer‐generated randomization list (Blocked Stratified Randomization version 5; Steven Piantadosi), where randomization was applied in random blocks of two and four.”

Allocation concealment (selection bias)

Low risk

Quote:“Participants were allocated by a data manager in order of inclusion following the randomization list, placed in a sealed envelope.”

Blinding of participants (performance bias)

High risk

Unable to blind participants to intervention

Blinding of personnel (performance bias)

High risk

Masking: None (registry)

Blinding of outcome assessment [objective] (detection bias)

Unclear risk

Physical activity (unclear if assessed during intervention)

Blinding of outcome assessment [other] (detection bias)

High risk

Masking: None (registry)

Incomplete outcome data (attrition bias)
All outcomes

High risk

Flow chart provided and attrition documented

Quote:“Although 101 patients fulfilled the COPE II study criteria, only 29 patients (29%) were able and willing to participate. The reason for not participating was that patients did not fulfill the additional criterion of having a computer with Internet access at home….

A large number of patients were not able or willing to continue study participation: 33% in the intervention group and 86% in the control group…

Although some patients in the intervention group quit the physiotherapy modules (exercising and activity coach) due to weak (n=1, ,T1) or unstable condition (n=1, ,T2) and personal circumstances (n=2, ,T4), they persisted in using the web portal and triage diary till T4.”

Selective reporting (reporting bias)

High risk

Results only presented for T0, T1, T2

Other bias

Unclear risk

SAMPLE SIZE

Registry: n = 30

Paper: “sample size was based upon the estimated number of patients that could be included within the recruitment period and the availability of technology”

Tahirah 2015

Methods

DESIGN 2 groups

DATES not reported (abstract only)

SETTING hospital (? Malaysia)

SAMPLE SIZE not reported (abstract only)

Participants

INCLUSION CRITERIA (as in registry)

  • Within 48 hours of admission for AECOPD

EXCLUSION CRITERIA

  • Any contraindication to exercise as listed by the American College of Sports Medicine

  • Hospitalisation within 14 days

  • Inability to understand or speak English or Malay

BASELINE CHARACTERISTICS

  • INTERVENTION exercise training (n = 20)

AGE mean 62 (SD 7) years; SEX 20 (100%) male; FEV1 mean 33 (SD 14)% predicted

  • NO INTERVENTION (n = 18)

AGE mean 66 (SD 8) years; SEX 17 (94%) male; FEV1 mean 34 (14)% predicted

Interventions

DURATION OF INTERVENTION length of stay

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION exercise training (progressive walking and functional resistance exercises)

DURATION during admission for AECOPD

SETTING inpatient

CONTACT commenced within 48 hours of admission, until discharge

  • 5 weekdays, 2 sessions a day (morning session supervised, afternoon session unsupervised), ≤ 30 minutes

AEROBIC TRAINING walking

  • INITIAL PRESCRIPTION baseline 2 minute walk test

  • PROGRESSION every second day, 20% increase distance

STRENGTH TRAINING functional resistance exercises

  • INITIAL PRESCRIPTION sit to stand test (baseline)

  • PROGRESSION additional set on every second day

OTHER COMPONENTS afternoon session unsupervised

EDUCATION nil

NO INTERVENTION

as per Malaysian COPD clinical practice guidelines

usual physiotherapy care may comprise airway clearance (if required), strategies to minimise dyspnoea (e.g. pursed lip breathing and positioning), and encouragement to mobilise in the ward

Outcomes

DEVICE Stepwatch

  • Wear instructions, data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: hospital discharge

PRIMARY OUTCOMES baseline and prior to discharge

  • Exercise capacity: 2‐minute walk distance

  • Other: muscle strength

SECONDARY OUTCOMES:

  • Physical activity: step count

  • HRQOL: not assessed

  • Adherence: reported

  • Adverse events: not reported

  • Other: length of stay, functional performance

Notes

FUNDING, CONFLICT OF INTEREST not reported (abstract only)

CONTACT Fatim Tahirah [email protected] Curtin University, Perth (Australia)

Additional information provided: baseline characteristics, physical activity, exercise capacity

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "randomisation table created by computerised sequence generation"

Allocation concealment (selection bias)

Low risk

Quote: "sealed opaque envelopes"

Blinding of participants (performance bias)

Unclear risk

Quote: "Participants unable to be blinded to intervention but unaware of other treatment group’s intervention"

Blinding of personnel (performance bias)

High risk

Quote: "Not blinded: personnel"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

Exercise capacity:

Quote: "assessor blinded"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient information (abstract only)

Selective reporting (reporting bias)

Unclear risk

Registry: sit to stand test (not reported)

Other bias

Unclear risk

Abstract only

Troosters 2014

Methods

DESIGN 2 groups

DATES April 2007 to July 2010

SETTING 70 centres in 10 countries

SAMPLE SIZE calculation based on FEV1 area under the curve

Participants

INCLUSION CRITERIA

  • COPD (GOLD stage II: FEV1 ≥ 50% to < 80% predicted, post‐bronchodilator FER < 0.7)

  • Smoking history ≥ 10 pack‐years

  • Age 40 to 80 years

  • modified MRC dyspnoea scale (≥ grade 2)

  • Demonstrate compliance with HandiHaler, a salbutamol MDI and activity monitor

  • Acceptable spirometry and exercise stress test

EXCLUSION CRITERIA

  • Prior maintenance medication (LABA, inhaled or systemic corticosteroids, theophylline, leukotriene receptor antagonists) within 6 months

  • Current chronic treatment with systemic steroids

  • Diagnosis of asthma or cystic fibrosis

  • Upper and/or lower respiratory tract infection or AECOPD within 6 weeksg

MEDICATIONS

  • Open‐label salbutamol as needed was permitted as rescue medication

  • Prohibited medications: long‐acting β2‐agonists; short‐acting β2‐agonists (except salbutamol after Visit 1); oral β2‐agonists; ICS; ICS/long‐acting β2‐agonist combinations; oral corticosteroids; theophylline; leukotriene antagonists; all open‐label anticholinergics

  • Temporary oral corticosteroids (up to 2 weeks during the study treatment period) were permitted for AECOPD

BASELINE CHARACTERISTICS

  • INTERVENTION behavioural modification with LAMA (n = 238, completed n = 211)

AGE mean 61 (SD 8) years; SEX 167 (70%) male; FEV1 post‐bronchodilator mean 66 (SD 8)% predicted

  • INTERVENTION behavioural modification with placebo (n = 219, completed n = 198)

AGE mean 62 (SD 9) years; SEX 147 (67%) male; FEV1 post‐bronchodilator mean 66 (SD 8)% predicted

Interventions

DURATION OF INTERVENTION 24 weeks

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION behavioral modification

INTERFACE monthly individual session

ACTIVITY walking/cycling

STEP‐TRACKING nil

RECORD activity diary

GOALS

  • activity action plan based on downloaded monitor data and activity diary

  • progress (per protocol) walking/cycling on 3 out of 7 days: 15 minutes, 30 minutes

EDUCATION/RESOURCES educational DVDs

INTERVENTION LAMA (tiotropium, 18 μg) once daily self‐administered morning via HandiHaler

PLACEBO once daily self‐administered morning via HandiHaler

Outcomes

DEVICE SenseWear Armband (software version 6.1) (right upper arm)

  • Wear instructions: 7 days, waking hours (remove for personal hygiene, avoid water contact)

  • Data inclusion criteria: ≥ 12 weeks, ≥ 4 days, ≥ 11 hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 12 weeks

  • End intervention: 24 weeks

PRIMARY OUTCOME

  • Other: spirometry

SECONDARY OUTCOMES

  • Physical activity: step count (data from graph), LIPA time (age 40 to 64 years, 2.5 to 4.4 METs; 65 to 79 years, 2 to 3.5 METs), MVPA time (age 40 to 64 years, 4.5 to 5.9 METs; 65 to 79 years, 3.6 to 4.7 METs) (data from graph), active EE

  • HRQOL: not assessed

  • Exercise capacity: not assessed

  • Adherence: not reported for behaviour modification component

  • Adverse events: reported

  • Other: spirometry, health status, work productivity

Notes

FUNDING "The study was funded by Pfizer Inc and Boehringer Ingelheim Pharma GmbH & Co KG."

CONFLICT OF INTEREST statement provided

CONTACT Thierry Troosters [email protected] KU Leuven (Belgium)

Additional information requested: unable to source from Pfizer

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "randomized, double‐blind, placebo‐controlled, multinational study" (protocol)

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

Low risk

Quote: "placebo"

Blinding of personnel (performance bias)

Unclear risk

Not specified

Quote: "double‐blind treatment phase"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

N/A

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

Unclear risk

Protocol: LIPA time, patient diary (not reported)

Paper: safety evaluation, adverse events, serous adverse events, AECOPD (additional outcomes reported)

Other bias

Unclear risk

Quote: "When this study was designed (in 2006/7), physical activity monitoring was in its infancy. We therefore did not include physical activity as a primary endpoint. Today there is more clarity on factors affecting the outcome of such monitoring, number of days of assessment needed, hours/day and validity of activity monitors in COPD. We measured physical activity using a validated activity monitor as an exploratory endpoint, which allowed for some flexibility in the analysis"

Troosters 2018

Methods

DESIGN 4 groups N.B. all groups received 12 weeks behaviour modification (5 comparisons)

  • LAMA vs. placebo

  • LAMA/LABA vs. placebo

  • LAMA/LABA vs. LAMA

  • LAMA/LABA with exercise training vs. LAMA

  • LAMA/LABA with exercise training vs. LAMA/LABA

DATES March 2014 to October 2015

SETTING "17 academic institutes, 15 secondary care and 5 primary care centres" (Australia, New Zealand, the USA, Canada and Europe)

SAMPLE SIZE calculation based on "EET for each arm compared to self‐management with placebo"

"Comparisons between the three non‐placebo arms were also performed; however, the trial was not designed or powered for these comparisons"

Participants

INCLUSION CRITERIA

  • COPD (GOLD stage II to III: post‐bronchodilator FEV1 ≥ 30% to < 80% predicted, FER < 0.7)

  • Smoking history > 10 pack‐years

  • Age ≥ 40 to ≤ 75 years

  • No AECOPD within 1 month

EXCLUSION CRITERIA

  • Significant disease other than COPD, history of asthma

  • Clinically‐relevant abnormal baseline haematology, blood chemistry or urinalysis

  • Conditions excluding them from exercise

FROM ONLINE SUPPLEMENT "Patients on continuous home oxygen were excluded from the study... Willingness to increase physical activity is not an inclusion criterion but patients have to be willing to take part in the 8‐week exercise training program (1 in 4 chance of being randomised to the treatment arm that includes exercise training) and take part in the behaviour‐change self‐management program."

MEDICATIONS "Patients are permitted to continue with inhaled corticosteroids but not LAMAs, LABAs or short‐acting muscarinic antagonists during the trial, and all are provided with open‐label salbutamol for rescue medication use throughout the trial. Acute exacerbations can be treated as medically necessary."

BASELINE CHARACTERISTICS

  • INTERVENTION behaviour modification with placebo (n = 65)

AGE mean 64 (SD 7) years; SEX 46 (71%) male; FEV1 post‐bronchodilator mean 56 (SD 14)% predicted

  • INTERVENTION behaviour modification with LAMA (n = 67)

AGE mean 66 (SD 6) years; SEX 51 (76%) male; FEV1 post‐bronchodilator mean 57 (SD 13)% predicted

  • INTERVENTION behaviour modification with LAMA/LABA (n = 72)

AGE mean 65 (SD 7) years; SEX 45 (63%) male; FEV1 post‐bronchodilator mean 59 (SD 11)% predicted

  • INTERVENTION: behaviour modification with LAMA/LABA and exercise training (n = 70)

AGE mean 65 (SD 7) years; SEX 42 (60%) male; FEV1 post‐bronchodilator mean 57 (SD 13)% predicted

Interventions

DURATION OF INTERVENTION 12 weeks (exercise training first 8 weeks)

FOLLOW‐UP no

SUPERVISION no

INTERVENTION placebo once daily

INTERVENTION LAMA (tiotropium 5 µg) once daily

INTERVENTION LAMA/LABA (tiotropium+olodaterol 5/5 µg) once daily

INTERVENTION LAMA/LABA (tiotropium+olodaterol 5/5 µg) once daily with exercise training

INTERVENTION behaviour modification

DURATION 12 weeks

INTERFACE

  • 1 individual session

  • Group session Weeks 2, 5, 8, 11

  • 1 individual follow‐up session (Week 15)

ACTIVITY Not specified

STEP‐TRACKING Pedometer OMRON HJ‐321 (direct feedback)

RECORD "patient worksheet"

GOALS

  • Baseline: participant’s ultimate goal is defined

  • Pedometer: intermediate goals (e.g. daily steps before the next session).

EDUCATION/RESOURCES

  • Booklet Living Well with COPD programme

  • Group education sessions including set and review physical activity goals

  • Assigned reading

  • Assessments

INTERVENTION high‐intensity whole‐body exercise training

SETTING outpatient

CONTACT 3 sessions per week

AEROBIC TRAINING 30 minutes stationary leg cycling or treadmill walking

  • TARGET INTENSITY

    • 80% maximum heart rate (incremental work‐capacity exercise)

    • Borg scale dyspnoea (rating 4 to 6)

STRENGTH TRAINING upper and lower limbs, 45 minutes

  • INITIAL PRESCRIPTION First 2 weeks: 2 sets, 8 to 10 repetitions, 60% 1RM

  • PROGRESSION 3 sets, 10 repetitions; resistance increased when able to complete > 10 repetitions

OTHER COMPONENTS, EDUCATION nil

Outcomes

DEVICE MoveMonitor

  • Wear instructions: 7 days, waking hours

  • Data inclusion criteria: ≥ 4 non‐weekend days, ≥ 8 hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: week prior to week 9 (end exercise training component)

  • End intervention: week prior to week 12

PRIMARY OUTCOME

  • Exercise capacity: ESWT (week 8) (data from abstract)

SECONDARY OUTCOMES

  • Physical activity: step count, time walking, walking intensity

  • HRQOL: CRQ dyspnoea domain (week 9, week 12) [(ata from graph)

  • Exercise capacity: endurance time (cycle ergometry; week 12), 6MWD (week 8, week 12)

  • Adherence: not reported

  • Adverse events: reported

  • Other: dyspnoea, difficulty, functional status, rescue medication use, physical activity (subjective)

Notes

FUNDING "Troosters: Funding This work was supported by Boehringer Ingelheim Pharma GmbH & Co. KG. Medical writing assistance was provided by Claire Scofield of Complete HealthVizion, which was contracted and compensated by Boehringer Pharma GmbH & Co. KG. The PROactive project is funded by the IMI‐JU (#115011). The PHYSACTO trial is an in‐kind contribution of the sponsor Boehringer Ingelheim to the PROactive project. In this project, the innovative patient‐reported outcome tool and the activity monitor were developed and validated.

Bourbeau: The PROactive project is funded by the IMI‐JU grant number #115011. The PHYSACTO trial is an in‐kind contribution of the sponsor Boehringer Ingelheim to the PROactive project

Acknowledgements Medical writing assistance was provided by Laura George, PhD, of Complete HealthVizion, which was contracted and compensated by Boehringer Ingelheim Pharma Inc."

CONFLICT OF INTEREST "Competing interests JB has received grants from the Canadian Institute of Health Research R&D collaborative programme (AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Merck, Nycomed, Novartis), the Canadian Respiratory Research Network, the Respiratory Health Network of the FRQS and the Research Institute of the MUHC. KLL reports personal fees from the study sponsor for personnel training, as well as a grant from AbbVie and personal fees from Bayer, Janssen, Novartis, AbbVie, Mundipharma and Almirall. MS is employed by Respiplus, a non‐profit organisation that was contracted by the study sponsor to develop the educational component of the training programme. DDS, DE and AH are employees of Boehringer Ingelheim. FM has received grants from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Nycomed and Pfizer, personal fees from Boehringer Ingelheim, GlaxoSmithKline and Novartis, and other financial support from GlaxoSmithKline. TT has received grants from the Innovative Medicines Initiative Joint Undertaking and speaker fees from Boehringer Ingelheim and GlaxoSmithKline. NL is employed by Evidera, a healthcare research firm that provides consulting and other research services to pharmaceutical and other organisations including the study sponsor. The authors meet the criteria for authorship as recommended by the International Committee of Medical Journal Editors. They take full responsibility for the scope, direction, content of, and editorial decisions relating to the manuscript, were involved in reviewing and revising the manuscript at all stages of development, and have approved the submitted manuscript.

Troosters: Competing interests TT has received grants from the Innovative Medicines Initiative Joint Undertaking and speaker fees from Boehringer Ingelheim and GlaxoSmithKline. JB has received grants from the Canadian Institute of Health Research R&D collaborative programme (AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Merck, Nycomed, Novartis), the Canadian Respiratory Research Network, the Respiratory Health Network of the FRQS and the Research Institute of the MUHC. FM has received grants from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Nycomed and Pfizer, personal fees from Boehringer Ingelheim, GlaxoSmithKline and Novartis, and other financial support from GlaxoSmithKline. NL is employed by Evidera, a healthcare research firm that provides consulting and other research services to pharmaceutical and other organisations including the study sponsor. DE, DDS, LK and AH are employees of Boehringer Ingelheim. DE, DDS and AH are employees of the sponsor and were involved in the design, implementation and interpretation of the study results, together with the investigators

Registry: Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Restriction Description: Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights."

CONTACT Thierry Troosters [email protected] KU Leuven (Belgium)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomisation is performed using a pseudo‐random number generator and block randomisation is used to achieve balanced allocation"

Allocation concealment (selection bias)

Low risk

Quote: "Patients are assigned to treatment arms using a web‐based and telephone‐based response system, and provided with numbered medication boxes"

Blinding of participants (performance bias)

Unclear risk

Quote: "A double‐blind design is used for the groups receiving placebo & behaviour modification, (LAMA) & behaviour modification, and (LAMA/LABA) & behaviour modification"

Quote: "It is not possible to blind the participants or staff against the group receiving (exercise training)"

Blinding of personnel (performance bias)

Unclear risk

Quote: "A double‐blind design is used for the groups receiving placebo+behaviour modification, tiotropium monotherapy+behaviour modification, and tiotropium +olodaterol+behaviour modification"

Quote: "It is not possible to blind the participants or staff against the group receiving (exercise training)"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity:

Quote: "A double‐blind design is used for the groups receiving placebo+behaviour modification, tiotropium monotherapy+behaviour modification, and tiotropium +olodaterol+behaviour modification"

Quote: "It is not possible to blind the participants or staff against the group receiving (exercise training)"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Low risk

Paper: CRQ, dyspnoea, medication adherence (additional outcomes reported)

Other bias

Unclear risk

Registry:

Study start March 2014

Study completion October 2015

Original entry: 3 arms

Modifications made November 2016: four arms

Tsai 2016

Methods

DESIGN 2 groups

DATES not reported

SETTING tertiary hospital PR programme (Australia)

SAMPLE SIZE calculation based on ESWT

Participants

INCLUSION CRITERIA

  • Can operate a computer independently (following training) with adequate hearing and eyesight

  • < 150 kg (bike weight limit)

  • Uses a stationary exercise cycle independently

  • Adequate space in the home for a stationary lower‐limb cycle ergometer and a walking course

  • Walking course at least 8 metres (measured by a physiotherapist using a trundlewheel)

  • Mobilise independently without a walking frame

EXCLUSION CRITERIA

  • Any exercise programme within 12 months

  • Admitted to hospital for AECOPD within 2 months

  • Mini Mental State Examination score < 24

  • Unstable cardiac or neurological disease

  • Home oxygen therapy

  • Unable to understand English

  • Lived in an area without adequate internet coverage

BASELINE CHARACTERISTICS

  • INTERVENTION PR (telerehabilitation) (n = 19)

AGE mean 73 (8) years; SEX 12 (63%) male; FEV1 mean 60 (SD 23)% predicted

  • NO INTERVENTION (n = 17)

AGE mean 75 (SD 9) years; SEX 6 (35%) male; FEV1 mean 68 (SD 19)% predicted

Interventions

DURATION OF INTERVENTION 8 weeks

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION PR (telerehabilitation)

SETTING home (laptop computer with an in‐built camera), outpatient group (maximum 4 participants)

CONTACT

  • Initial home visit

  • 3 sessions a week

AEROBIC TRAINING

  • Lower‐limb cycle ergometry 15 to 20 minutes

    • INITIAL PRESCRIPTION 60% to 80% baseline 6MWD peak work rate (algorithm for cycle prescription)

    • PROGRESSION increase by 5 watts

  • Walking training 15 to 20 minutes

    • INITIAL PRESCRIPTION 80% of average baseline 6MWT speed

    • PROGRESSION increase speed

  • TRAINING INTENSITY modified Borg scale dyspnoea and rate of perceived exertion (rating 3 to 4)

STRENGTH TRAINING sit to stand, squats (3 sets, 10 repetitions)

OTHER COMPONENTS, EDUCATION nil

Outcomes

DEVICE SenseWear (software version 8.0) (left upper arm)

  • Wear instructions: 6 consecutive days, 24 hours a day (except water‐related activity)

  • Data inclusion criteria: ≥ 3 days, ≥ 85% (20.5 hours)

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 8 weeks

PRIMARY OUTCOME

  • Exercise capacity: ESWT

SECONDARY OUTCOMES

  • Physical activity: step count, sedentary time (< 1.5 METs), LIPA time (between 1.5 and 3 METs), time in moderate‐intensity physical activity (3 to 6 METs), time in vigorous‐intensity physical activity (6 to 9 METs), time in very vigorous‐intensity physical activity > 9 METs), PAL, total EE

  • HRQOL: CRQ, CAT

  • Exercise capacity: 6MWD

  • Adherence: reported

  • Adverse events: reported

  • Other: dyspnoea, functional performance, anxiety and depression, self‐efficacy for PR

Notes

FUNDING reported

CONFLICT OF INTEREST statement not provided

CONTACT Ling Ling Tsai [email protected] University of Sydney (Australia)

Adiitional information provided: clarification for total energy expenditure units (kcal), thresholds for classification of physical activity according to intensity (light, moderate) and results for all time in physical activity greater than three METs (to enable inclusion in meta‐analysis).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "This study was a prospective, blinded (assessor and statistician) RCT. Participants were randomized by one of the investigators (L.L.Y.T.) using a computer‐generated sequence"

Allocation concealment (selection bias)

Unclear risk

Quote: "concealed allocation"

Blinding of participants (performance bias)

High risk

Unable to blind participant to intervention.

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "this study was a prospective, blinded (assessor and statistician) RCT… measurements which were performed by a research assistant who was blind to group allocation"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

Unclear risk

SECONDARY OUTCOMES

Registry: satisfaction, semi‐structured interview post telerehabilitation (not reported in paper)

Other bias

Low risk

N/A

Van de Bool 2017

Methods

DESIGN

Stage 1 2 groups (intervention (nutritional supplement) with PR vs. PR)

Stage 2 2 groups (intervention (nutritional supplement) with PAC vs. PAC)

DATES September 2011 to April 2014

SETTING outpatient PR programme in 7 hospitals (The Netherlands)

SAMPLE SIZE calculation based on peak torque

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (post‐bronchodilator FER < 0.7)

  • Referred for PR

  • Low muscle mass (fat‐free mass < 25th percentile values)

EXCLUSION CRITERIA

  • Allergy or intolerance to components of the study product

  • Participating in any other study involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study.

  • Pregnancy

  • Life expectancy < 6 months

  • Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements

BASELINE CHARACTERISTICS

  • INTERVENTION nutritional supplement with PR (n = 42, completed n = 38)

AGE mean 63 (SEM 1) years; SEX 18 (43%) male; FEV1 mean 57 (SEM 3)% predicted

  • INTERVENTION placebo with PR (n = 39, completed n = 35)

AGE mean 62 (SEM 1) years; SEX 23 (59%) male; FEV1 mean 53 (SEM 3)% predicted

Interventions

DURATION OF INTERVENTION

Phase 1: 4‐month nutritional intervention

Phase 2: 8‐month maintenance phase

FOLLOW‐UP Phase 3: up for 3 months, without any intervention in either group

SUPERVISION no

PHASE 1

COMMON INTERVENTION

4‐month outpatient centre‐based pulmonary rehabilitation

  • consume 3 portions of the supplement daily

  • 40 training sessions supervised by trained physiotherapists

    • 2 to 3 sessions a week

    • high‐intensity endurance exercise by cycle ergometry and treadmill walking

    • progressive resistance exercise of upper and lower body at 75% 1RM

  • education about COPD, exercise, healthy nutrition

  • smokers: standardised smoking cessation support.

INTERVENTION

protein, carbohydrates, fat and micronutrients, enriched with leucine, omega‐3 PUFA, and vitamin D (Nutricia NV, Zoetermeer, The Netherlands)

PLACEBO

flavoured non‐caloric cloudified aqueous solution, no active components

PHASE 2

COMMON INTERVENTION

Both groups received feedback on their physical activity behaviour twice, based on accelerometry

INTERVENTION

1 oral nutritional supplement a day, four nutritional counselling sessions

Outcomes

DEVICE GT3X Actigraph accelerometer

  • Wear instructions: 7 consecutive days, waking hours (except when showering or bathing)

  • Data inclusion criteria: ≥ 5 days

ASSESSMENT TIME POINTS

  • Baseline

  • End Stage 1 intervention: 4 months

  • End Stage 2 intervention: 12 months

  • End follow‐up: 15 months

PRIMARY OUTCOME

  • Other: muscle strength

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: SGRQ, EQ5D

  • Exercise capacity: endurance time (cycle ergometry), 6MWD

  • Adherence: not reported for PR component

  • Adverse events: reported

  • Other: dietary intake, vitamin D, branched‐chain amino acids and fatty acid profile, body composition, inspiratory muscle strength, anxiety and depression

Notes

FUNDING "This study was financially supported by a Public–Private Consortium of Maastricht University/NUTRIM, CIRO+ BV Horn, Lung Foundation Netherlands (grant 3.4.09.003), and Nutricia Research."

CONFLICT OF INTEREST "ER, FF and EW declare that they have no conflict of interest regarding the present manuscript. AvH is employed by Nutricia Research. CvdB and AS report grants from Netherlands Lung Foundation and Nutricia." Research, during the conduct of the study. AS is a member of International Scientific Advisory Board of Nutricia Advanced Medical Nutrition."

CONTACT Annemie Schols [email protected] Maastricht University Medical Center, (The Netherlands)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The randomization sequence was generated using the PLAN procedure of SAS statistical software (Enterprise Guide version 4.3) by a statistician from Nutricia Research who had no further involvement in the conduct of the study. The permuted block randomization was stratified for site, with a 1:1 allocation ratio"

Allocation concealment (selection bias)

Low risk

Quote: "All details of the randomization, including block size, were unknown to the investigator, site staff, and study staff, except for the statistician who was responsible for generating the randomization sequence, and the supplies manager who needed to be unblinded in order to label the study products and to create unblinding envelopes, etc"

Blinding of participants (performance bias)

Low risk

Quote: "The packaging of the test product and control product were identical in appearance. The study product was labelled using product numbers. Which product numbers corresponded to which treatment was only known to the statistician who was responsible for generating the randomization sequence and the clinical studies supplies manager"

Blinding of personnel (performance bias)

Low risk

Quote: "The packaging of the test product and control product were identical in appearance. The study product was labelled using product numbers. Which product numbers corresponded to which treatment was only known to the statistician who was responsible for generating the randomization sequence and the clinical studies supplies manager"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity and exercise capacity (cycle ergometry)

Blinding of outcome assessment [other] (detection bias)

Unclear risk

Exercise capacity (6MWD):"double blind" (paper), "triple blind"(registry)

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Quote: "Two of the 81 randomized patients did not start the treatment. During the PR, the drop‐out rate was 9.5% (four patients) in NUTRITION and 5.4% (two patients) in PLACEBO"

Selective reporting (reporting bias)

Unclear risk

PRIMARY OUTCOME

Registry: skeletal muscle strength (baseline, 12 months)

Paper: quadriceps muscle strength (baseline, 4 months)

SECONDARY OUTCOMES

Registry:

  • Cardiometabolic risk profile (baseline, 4 months, 12 months)

  • HRQOL (baseline, 4 months, 12 months, 15 months) (SF36)

  • Dyspnoea (baseline, 4 months, 12 months, 15 months)

Paper:

  • variables listed above not reported

  • additional outcomes

    • inspiratory muscle strength

    • habitual dietary intake

    • 6MWD “exploratory”

    • hospital anxiety and depression scale “exploratory”

Other bias

Unclear risk

Quote "Patient inclusion was prematurely discontinued because the test product could not be produced within the appropriate quality specifications due to discontinuation of the supply of one of the ingredients, but justifiable based on other RCTs published in the meantime as argued in the discussion"

Varas 2018

Methods

DESIGN 2 groups

DATES not reported

SETTING University (Spain)

SAMPLE SIZE not reported

Participants

"Recruitment was conducted by the pulmonology consultants of the aforementioned hospitals, using an intentional system of consecutive series"

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD criteria)

  • No AECOPD within 4 weeks

  • Exertional dyspnoea

  • Low habitual physical activity level (< 30 minutes of moderate exercise a day) (self‐report as in author correspondence)

EXCLUSION CRITERIA

  • Difficulty walking

  • Cardiovascular diseases (except high blood pressure)

  • PR within 1 year

BASELINE CHARACTERISTICS

  • INTERVENTION: PAC and exercise training with pedometer (n = 21, completed n = 17)

AGE mean 70 (SD 7) years; SEX 18 (86%) male; FEV1 mean 46 (SD 17)% predicted

  • INTERVENTION: pedometer (n = 19, completed n = 16)

AGE 65 (SD 9) years; SEX 13 (68%) male; FEV1 mean 52 (SD 16)% predicted

Interventions

DURATION OF INTERVENTION 8 weeks

FOLLOW‐UP 12 months

SUPERVISION no

INTERVENTION PAC and exercise training

INTERFACE weekly phone call

ACTIVITY walking 5 sessions a week, 30 to 60 minutes (15‐ to 20‐minute cycles) (as for ISWT)

STEP‐TRACKING pedometer (direct feedback, control walking speed)

RECORD diary: daily step count

GOALS revised weekly, 10% to 20% increase

EDUCATION/RESOURCES nil

INTERVENTION pedometer

ACTIVITY walking

STEP‐TRACKING pedometer (direct feedback)

GOALS general recommendations to walk more every day

EDUCATION/RESOURCES 5 group sessions of respiratory physiotherapy (ventilation techniques, bronchial clearance, thoracic mobilisation, education). "This initial intervention, considered as “standard care” in a PR programme, has shown no influence in the variables we analysed" (Spruit 2013)

INTERFACE, RECORD nil

Outcomes

DEVICE OMRON Walking Style X Pocket HJ‐320e (pedometer) (waist, next to right hip)

  • wear instructions: 7 consecutive days, waking hours

  • data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 10 weeks

  • Follow‐up: 3 months post‐intervention

  • Follow‐up: 12 months post‐intervention

PRIMARY OUTCOME

  • Physical activity: step count

  • Exercise capacity: ESWT

SECONDARY OUTCOMES

  • HRQOL: SGRQ

  • Adherence: not reported

  • Adverse events: not reported

  • Other: dyspnoea, number of AECOPD over the last 12 months

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Jordi Vilaró [email protected] Universidad Autónoma de Madrid (Spain)

Additional information provided: 'Risk of bias' assessment

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Patients were allocated to one of two groups (experimental or control) through simple randomization, using a system of random numbers generated by Microsoft® Excel 2010"

Allocation concealment (selection bias)

Unclear risk

Quote: "The allocation sequence was concealed" (correspondence)

Blinding of participants (performance bias)

Low risk

Quote: "Participants were not aware of the interventions applied to the other group, and contact between the two groups was avoided at all times"

Blinding of personnel (performance bias)

High risk

Quote: "Correspondence between numerical codes and study group was only available to researchers in charge of the treatment, not to evaluators"

Blinding of outcome assessment [objective] (detection bias)

Unclear risk

Physical activity:

Quote: "obtained the data recorded in the memory of the device and the data collected by the patients every day in a diary. We confirmed that either data coincident or, we accepted when there was a variation lower than 10%" (correspondence)

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "correspondence between numerical codes and study group was only available to researchers in charge of the treatment, not to evaluators"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Unclear risk

No trial registry; results presented as in Methods

Other bias

Unclear risk

  • Discrepancy between groups at baseline not discussed (especially with regard to step count)

  • "Two were excluded for noncompliance during the intervention phase (17.5% loss)". Author correspondence states "non‐compliance of the program was established previously, before starting the study, by considering none achieving the individual target of steps/week for three consecutive weeks" indicating departure from intention‐to‐treat analysis

Vasilopoulou 2017

Methods

DESIGN 3 groups, 2 phases

  • eight weeks HIIT vs. no intervention

  • 12 months maintenance (telerehabilitation) vs. no intervention

  • 12 months maintenance (centre‐based) vs. no intervention

  • 12 months maintenance (telerehabilitation) vs. 12 months maintenance (centre‐based)

DATES not reported

SETTING outpatient clinic (Greece)

SAMPLE SIZE calculation based on number of hospitalisations for AECOPD

Participants

"The majority of patients were referred to the PR programme because of persistent respiratory symptoms, but also following hospitalisation for acute exacerbation of COPD (four patients in group A and six patients in group B). These patients were included in the study at least 8 weeks after the hospitalisation. None of these patients had previously participated in a PR programme."

INCLUSION CRITERIA

  • Diagnosis of COPD (post‐bronchodilation FEV1 < 80% predicted, FER < 0.7)

  • Age ≥ 40 years

  • Clinically stable

  • Regularly attending outpatient clinic

  • Optimal medical treatment (GOLD guidelines) without regular use of systemic corticosteroids

  • History of AECOPD within 1 year

Additional as per registry

  • FER < 75% without significant post‐bronchodilator reversibility (FEV1 < 10% predicted)

  • Smoking history (current or former) ≥ 10 pack‐years

  • ≥ 2 AECOPD within 1 year

EXCLUSION CRITERIA

  • Diagnosis of orthopaedic, neurological and other conditions that significantly impair exercise tolerance

  • Respiratory disorders other than COPD

  • Cognitive impairment and/or difficulties in managing electronic devices that precluded interactions with the tablet, as judged by the investigator

Additional as in registry

  • Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator Specifically if the participant's condition/ co‐morbidities are such that physical activity cannot be increased

  • Not on optimal pharmacotherapy

BASELINE CHARACTERISTICS

  • INTERVENTION: 8 weeks exercise training (HIIT) then 12 months maintenance (telerehabilitation) (n = 47)

AGE mean 67 (SD 10) years; SEX 44 (94%) male; FEV1 mean 50 (SD 22)% predicted

  • INTERVENTION: 8 weeks exercise training (HIIT) then 12 months maintenance (centre‐based) (n = 50)

AGE mean 67 (SD 7) years; SEX 38 (76%) male; FEV1 mean 52 (SD 17)% predicted

  • NO INTERVENTION (n = 50)

AGE mean 64 (SD 8) years; SEX 37 (74%) male; FEV1 mean 52 (SD 21)% predicted

Interventions

DURATION OF INTERVENTION 14 months

FOLLOW‐UP no

SUPERVISION yes

INTERVENTION exercise training (HIIT)

DURATION 8 weeks

SETTING centre‐based outpatient group

CONTACT 3 sessions a week

AEROBIC TRAINING cycling 45 minutes, alternating 30‐second exercise intervals with 30‐second rest periods

  • INITIAL PRESCRIPTION 100% peak work rate

  • PROGRESSION weekly, 5% increase in total workload

STRENGTH TRAINING upper and lower limbs, 15 minutes (3 sets, 10 repetitions)

OTHER COMPONENTS advice from dietician

EDUCATION instructions on breathing control, self‐management techniques

INTERVENTION maintenance (telerehabilitation)

DURATION 12 month

SETTING home

CONTACT 1 session a week, 1 hour (144 sessions) telephone or video conference (tablet)

AEROBIC TRAINING individually‐tailored home‐based exercise programme: walking drills

STRENGTH TRAINING upper and lower limbs, 3 sets, 10 to 12 repetitions

OTHER COMPONENTS

  • Online exercise diary for home‐based sessions (heart rate, oxygen saturation), modified Borg scale dyspnoea and leg discomfort: data transmitted to the web‐based platform

  • PROGRESSION 3 times a week revision of exercise training loads according to symptoms and recorded vital signs

EDUCATION individualised action plan, brochure of prescribed exercises, video demonstrations: home exercises, breathing retraining techniques, educational leaflets for COPD, instruction on management of anxiety and depression symptoms, dietary and self‐management advice

INTERVENTION maintenance (centre‐based)

DURATION 12 months

SETTING outpatient group

CONTACT 2 sessions a week (96 sessions)

AEROBIC and STRENGTH TRAINING “exercise training”

OTHER COMPONENTS nil

EDUCATION physiotherapy, dietary and psychological advice

Outcomes

DEVICE Actigraph GT3X (ActiLife software version 5.10.0) (waist, above right hip)

  • Wear instructions: not reported

  • Data inclusion criteria: ≥ 4 days (including weekends), ≥ 480 minutes during waking hours (07:00 to 22:00)

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 8 weeks (end HIIT)

  • End intervention: 14 months

PRIMARY OUTCOME (12 months following completion of HIIT)

  • Other:

    • rate of moderate‐to‐severe AECOPD

    • hospitalisations due to AECOPD

    • emergency department visits

SECONDARY OUTCOMES

  • Physical activity: sedentary time, time in "lifestyle" physical activity, LIPA time, MVPA time (thresholds not defined)

  • HRQOL: SGRQ, CAT

  • Exercise capacity: peak work rate (cycle ergometry), 6MWD

  • Adverse events: not reported

  • Adherence: not reported for exercise training component

  • Other: spirometry, dyspnoea

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Ioannis Vogiatzis [email protected], Maroula Vasilopoulou [email protected] National and Kapodistrian University of Athens (Greece)

Additional results provided: scale for graph of time in moderate‐intensity physical activity

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "randomised into 3 groups using a set of computer‐generated random numbers"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

High risk

Quote: "Masking: None (Open Label)"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Unclear risk

HRQOL and exercise capacity:

Quote: "Masking: None (Open Label)"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

CONSORT diagram provided

Quote: "During the 2‐month primary PR programme, three patients from group A were discontinued from the study because of transport barriers"

Selective reporting (reporting bias)

High risk

PRIMARY OUTCOMES discrepancy between registry and paper

Registry:

  • number of exacerbations in 12 months

  • unscheduled hospital admissions due to exacerbations

Methods and Results:

  • rate of moderate/severe AECOPD

  • rate of emergency department visits with AECOPD that did not require hospital admission (secondary outcome in registry)

SECONDARY OUTCOMES

Paper: cycle ergometry, adherence (additional outcomes)

Other bias

Unclear risk

Quote: "During the period spanning from December 2013 to July 2015, patients in groups A and B initially completed a multidisciplinary intense hospital‐based, outpatient, pulmonary rehabilitation programme lasting for 2 months, which was followed by a 12‐month maintenance rehabilitation programme... patients in group C followed the usual care treatment throughout the 14‐month period"

Registry:

First submitted: November 2015

Primary completion date: July 2015 (definition: final data collection date for primary outcome measure)

Study completion date: July 2016 (definition: final data for the primary outcome measures, secondary outcome measures and adverse events (the last participant's last visit).

Vorrink 2016

Methods

DESIGN 2 groups

DATES not reported

SETTING 32 physiotherapy practices (The Netherlands)

SAMPLE SIZE calculation based on weekday step count

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD Stage II or III: post‐bronchodilator FEV1 ≥ 30% to < 80%, FER < 0.7)

  • Age ≥ 40 years

  • Completed 3 months of PR within 6 months

  • Lived independently

EXCLUSION CRITERIA

  • Comorbidity that greatly influences physical activity

  • Using an assistive device for physical activity (e.g. walker or mobility scooter)

  • Intermittently‐ceased PR

  • Hospital admission for AECOPD withing 6 months

BASELINE CHARACTERISTICS

  • INTERVENTION PAC (app) with optional supervised exercise (n = 85, month 3 n = 72, month 6 n = 68, month 12 n = 62)

AGE mean 62 (SD 9) years; SEX 42 (50%) male; FEV1 mean 59 (SD 20)% predicted

  • INTERVENTION optional supervised exercise (n = 72, month 3 n = 67, month 6 n = 64, month 12 n = 59)

AGE mean 63 (SD 8) years; SEX 36 (49%) male; FEV1 mean 63 (SD 15)% predicted

Interventions

DURATION OF INTERVENTION 6 months

FOLLOW‐UP no

SUPERVISION no

INTERVENTION PAC (app)

INTERFACE

  • Smartphone app

  • Text messages

ACTIVITY not specified

STEP‐TRACKING accelerometer (in smartphone, direct feedback)

GOALS 30 intensive minutes a day

  • Protocol‐driven initial goals based on

    • daily step count goal: increase 20% from baseline average steps

    • weekly average step count during the 30 most intensive minutes, with additional 20% was minimum required number of steps in 1 minute to account for an intensive minute of physical activity

RECORD, EDUCATION/RESOURCES nil

INTERVENTION optional supervised exercise

SETTING optional, 1 to 2 sessions a week, group training sessions, local physiotherapy practices

Outcomes

DEVICE SenseWear Pro or MF‐SW mini armband (software version 7.1)

  • Wear instructions: seven successive days, waking hours (except water‐related activities)

  • Data inclusion criteria: not reported

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 3 months

  • End intervention: 6 months

  • Follow‐up: 12 months

PRIMARY/SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: CRQ

  • Exercise capacity: 6MWD (modified 10‐metre course)

  • Adherence: reported

  • Adverse events: not reported

  • Other: spirometry, humidity, atmospheric pressure and temperature

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Sigrid Vorrink [email protected] Utrecht University of Applied Sciences (The Netherlands)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "This was a multicentre, investigator‐blinded, randomised controlled trial…The patients included in the study were randomly assigned to the intervention or usual care group, independent of physiotherapy practice, based on a random number sequence generated in Excel (Microsoft, Redmond, WA, USA) before enrolment. These numbers ranged between 0 and 1. The values were categorised into 0 (usual care) and 1 (intervention), based on a 0.5 threshold. Subsequently, each newly recruited participant was given the first available number and enrolled in the corresponding group. Patients with and without long‐term physiotherapy after pulmonary rehabilitation…were separately randomised via stratification, because this was seen as a confounder"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "assessments were performed by two researchers that were blinded to the group allocation"

Incomplete outcome data (attrition bias)
All outcomes

High risk

Quote: "Drop‐out in the intervention group was higher (39% in the intervention group versus 27% in the usual care group), and it was also higher among females. Initial worries about the telephone contract (linked to a personal bank account) and fear of losing the device were reasons for patients to drop out of the study. After the consent form was adjusted to state explicitly that there would not be any financial ramifications, the drop‐out rate decreased"

Selective reporting (reporting bias)

Unclear risk

No trial registry; results presented as in Methods

Other bias

Unclear risk

Quote: "Patients with GOLD stage 4 disease were not included in the study, resulting in a sample not fully similar to other pulmonary rehabilitation studies. This was because their low physical activity level renders an intervention effect improbable"

Quote: "The present study was set up in primary care and did not measure outcomes at the start of the pulmonary rehabilitation programme. This makes it difficult to compare the decline in physical activity with the potentially beneficial effects of the preceding pulmonary rehabilitation programme"

Quote: "The intervention might have yielded different results in patients that did not complete a pulmonary rehabilitation programme. As there could be more room for improvement, physical activity levels could have increased. This has been shown in previous pedometer studies. Nevertheless, as the intervention was not successful in maintaining physical activity in patients after pulmonary rehabilitation, the question remains whether it is capable of improving physical activity in patients without pulmonary rehabilitation"

Wan 2017

Methods

DESIGN 2 groups

DATES April 2012 to August 2015

SETTING general pulmonary clinics (USA)

SAMPLE SIZE calculation based on step count

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD, emphysema or chronic bronchitis (FER < 0.7 or computerised tomography evidence of emphysema)

  • Smoking history ≥ 10 pack‐years

  • Age ≥ 40 years

  • Able to walk at least 1 block

  • Approval and medical clearance from healthcare provider

  • Access to a computer with internet connection, a USB port and Windows operating system or be willing to come to the centre to use computers once a week

  • > 90% accuracy by Omron to detect step counts as compared to manual step counts during baseline clinic testing

EXCLUSION CRITERIA

  • AECOPD requiring prednisone or antibiotics within 1 month

  • Inability to ambulate due to pain or neuromuscular problems

  • Clinical signs of unstable cardiovascular disease or congestive heart failure

  • Access to only a Mac computer

  • PR within 3 months

  • Plans to participate in another interventional or exercise‐related research study, supervised exercise programme, such as PR, in the next 3 months

  • Desaturation to < 85% blood oxygen saturation during 6MWT

BASELINE CHARACTERISTICS

  • INTERVENTION PAC (web‐based) with pedometer (n = 57)

AGE mean 68 (SD 9) years; SEX 56 (98%) male; FEV1 mean 60 (SD 21)% predicted

  • INTERVENTION pedometer (n = 52)

AGE mean 69 (SD 8) years; SEX 51 (98%) male; FEV1 mean 66 (SD 22)% predicted

Interventions

DURATION OF INTERVENTION 12 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION PAC (web‐based, as per Moy 2015a)

INTERFACE website

ACTIVITY walking

STEP‐TRACKING pedometer (direct feedback)

RECORD website: step count weekly

GOALS website: display progress, protocol‐driven goal (revised weekly) minimum value of 3 possibilities: 1) 400 step increase from previous goal; 2) 400 step increase from 7‐day average; or 3) 10,000 steps

EDUCATION/RESOURCES website: education and motivational content, community forum

INTERVENTION pedometer

No instructions about exercise

INTERFACE website

ACTIVITY walking

STEP‐TRACKING pedometer (direct feedback)

RECORD website: step count monthly

GOALS nil

EDUCATION/RESOURCES written materials about exercise at study entry

Outcomes

DEVICE Omron HJ‐720 ITC (pedometer)

  • Baseline: walk 800 feet along a predetermined course at their usual speed; manual step counts were obtained simultaneously to confirm > 90% accuracy

  • Wear instructions: 7 days, all waking hours

  • Data inclusion criteria:

    • Baseline: ≥ 5 days

    • Week 1 to week 13: ≥ 3 days, ≥ 8 hours a day, ≥ 100 steps

ASSESSMENT TIME POINTS

PRIMARY OUTCOME

  • Weekly (week 1 to week 13)

SECONDARY OUTCOMES

  • Baseline

  • End intervention: 3 months

PRIMARY OUTCOME

  • Physical activity: step count

SECONDARY OUTCOMES

  • HRQOL: SGRQ

  • Exercise capacity: 6MWD (no practice walk)

  • Adherence: reported

  • Adverse events: reported

  • Other: depression, COPD knowledge, exercise self‐regulatory efficacy, social support, motivation and confidence to exercise

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Marilyn Moy [email protected], Emily Wan [email protected] VA Boston Healthcare System (USA)

Additional information provided: confirmed that data in text and Table 3 are SD (not standard errors)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Subjects were then randomized (1:1) by a computer algorithm"

Allocation concealment (selection bias)

Low risk

Quote: "Randomization assignments were generated with random block sizes which were not disclosed to study staff. Assignments were communicated to study staff through the ESC website, and subjects were notified by telephone of their assignment groups"

Blinding of participants (performance bias)

High risk

Quote: "Due to the nature of the intervention, participant blinding was not possible"

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "the research assistant conducting assessments at the study conclusion (3 months) was blinded to group assignment"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

High risk

PRIMARY OUTCOME

Registry: Originally 6MWD (January 2013) then changed to step count (March 2017) as in paper

Between April 2012 and August 2015, 114 participants were enrolled and randomised

SECONDARY OUTCOMES

Paper: 6MWD, exercise adherence, HRQOL, dyspnoea, depression, COPD knowledge, exercise self‐efficacy, social support, motivation, confidence to exercise daily (additional outcomes reported)

Other bias

Low risk

N/A

Watz 2016

Methods

DESIGN cross‐over trial (only pre‐cross‐over data used), 2 groups

DATES April 2014 to February 2015

SETTING 30 secondary care/pulmonology practices (Germany)

SAMPLE SIZE calculation based on physical activity

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD guidelines 2013: post‐bronchodilator (400 μg salbutamol) FEV1 ≥ 40% to < 80% predicted, FER < 0.7)

  • Smoking history (current or former) ≥ 10 pack‐years

  • Age ≥ 40 years

  • Stable

EXCLUSION CRITERIA

  • Concomitant pulmonary disease, history of asthma

  • Onset of respiratory symptoms prior to age 40 years

  • Blood eosinophil count > 600 mm3 during run‐in

  • Clinically‐significant abnormality that could interfere with the assessment of efficacy or safety of the study

  • AECOPD within 6 weeks

  • Respiratory tract infection within 4 weeks prior to screening or during the run‐in period

  • Contraindication for, or hypersensitivity to, anticholinergics, β2‐agonists, sympathomimetic amines, or lactose or any of the other excipients of the study medication

  • Participation in, or planning participation in, a pulmonary rehabilitation programme

  • Additional exclusion criteria as in registry:

  • Clinically‐significant ECG abnormality at visit 1, who in the judgement of the investigator would be at potential risk if enrolled into the study

  • Paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate‐control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at baseline and screening visits, with a resting ventricular rate < 100 beat a minute

  • Type I or uncontrolled Type II diabetes and patients with a history of blood glucose levels consistently outside the normal range. Patients with narrow‐angle glaucoma, symptomatic prostatic hyperplasia or bladder‐neck obstruction or moderate‐to‐severe renal impairment or urinary retention

  • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localised basal cell carcinoma of the skin. Patients with non‐melanoma skin carcinoma may be considered for the study.

  • BMI > 40 kg/m2

  • Women who are pregnant or breast feeding

  • Patients requiring long‐term oxygen therapy on a daily basis for chronic hypoxaemia

  • Clinically‐significant bronchiectasis

  • Other protocol‐defined inclusion/exclusion criteria may apply

MEDICATIONS

  • Prohibited: LAMAs (7 days); LABAs (48 hours; 7 days for indacaterol); xanthines and oral phosphodiesterase IV inhibitors (7 days).

  • Inhaled corticosteroids (ICSs) were permitted, at a stable dose throughout the study (participants on a LABA/ICS combination were to be switched to the nearest equivalent dose of ICS monotherapy at least 48 hours before visit 2).

  • "Salbutamol was permitted as rescue medication, but not within 6 hours of the start of any study visit"

BASELINE CHARACTERISTICS

  • INTERVENTION LAMA/LABA (n = 96)

AGE mean 64 (SD 8) years; SEX 64 (67%) male; FEV1 mean 63 (SD 10)% predicted

  • PLACEBO (n = 98)

AGE mean 61 (SD 8) years; SEX 63 (64%) male; FEV1 mean 60 (SD 11)% predicted

Interventions

DURATION OF INTERVENTION 3 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION LAMA/LABA (indacaterol/glycopyrronium (QVA149) 110/50 μg) once daily Breezhaler®

PLACEBO once daily Breezhaler®

Outcomes

DEVICE Sensewear (software version not reported)

  • Wear instructions: 7 days, 24 hours a day (except for time spent in personal hygiene)

  • Data inclusion criteria: > 21.5 hours, excluding first and last day of wear

TIME POINTS

  • Baseline

  • Pre‐cross‐over: 3 weeks

PRIMARY OUTCOMES

  • Other: spirometry

  • Physical activity: active EE (total EE subtract resting EE)

SECONDARY OUTCOMES

  • Physical activity: step count, MVPA time (> 3 METs), PAL (total daily EE / resting EE)

  • HRQOL: not assessed

  • Exercise capacity: not assessed

  • Adherence: reported

  • Adverse events: reported

  • Other: spirometry

Notes

FUNDING "This study was funded by Novartis Pharma GmbH. Employees of Novartis Pharma GmbH were involved in the design of the study and analysis, and interpretation of data and oversaw the collection of data. Two of the authors (CM and MB) are authors of the manuscript."

CONFLICT OF INTEREST statement provided

CONTACT Henrik Watz [email protected] German Center for Lung Research, Grosshansdorf (Germany)

Additional information provided: pre‐cross‐over results as per Novartis

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Patients were randomised to one of two treatment sequences in a ratio of 1:1 using a randomisation number from a list generated by the study sponsor. This list was produced using a validated automated system."

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

Low risk

Quote: "Masking: Double (Participant, Care Provider)"

Blinding of personnel (performance bias)

Low risk

Quote: "Masking: Double (Participant, Care Provider)"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

N/A

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

Low risk

All data reported as in registry

Other bias

Low risk

N/A

Watz 2017

Methods

DESIGN 2 groups (data from first 4 weeks only)

DATES April 2015 to July 2016

SETTING 26 sites (Canada, Germany, Hungary, Spain)

SAMPLE SIZE calculation based on spirometry

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD guidelines 2014: post‐bronchodilator FEV1 ≥ 40% to < 80% predicted, FER < 0.7)

  • Smoking history (current or former) ≥ 10 pack‐years

  • Age ≥ 40 years

  • FRC ≥ 120% predicted

  • modified MRC dyspnoea scale (grade 2 or greater)

  • Non‐pregnant, non‐lactating women

EXCLUSION CRITERIA

  • History or current diagnosis of asthma

  • Any respiratory tract infection (including upper respiratory tract) or AECOPD within 6 weeks

  • Hospitalisation for AECOPD within 3 months

  • Clinically‐significant respiratory conditions other than COPD or cardiovascular conditions

  • LTOT (15 hours a day)

  • Oxygen saturation ≤ 85% during exercise testing, cycled < 2 or > 15 minutes during the constant work rate exercise tests

  • BMI ≥ 40 kg/m2

  • PR during the study or within 3 months

  • Clinically‐relevant abnormalities in the results of blood pressure, ECG or physical examination

  • Conditions other than COPD that may have contributed to dyspnoea and exercise limitation or with contraindications to clinical exercise testing

MEDICATIONS

  • Prohibited medication; any bronchodilator treatment (except salbutamol as rescue medication), methylxanthine, phosphodiesterase type IV inhibitors

  • Inhaled corticosteroid therapy, oral or parenteral corticosteroids (10 mg of prednisone a day, 20 mg every other day)

  • Oxygen therapy < 15 hours a day if administration stable for at least 4 weeks

BASELINE CHARACTERISTICS

  • INTERVENTION LAMA/LABA (n = 134)

AGE mean 63 (SD 8) years; SEX 82 (61%) male; FEV1 post‐bronchodilator mean 60 (SD 11)% predicted

  • PLACEBO (n = 133)

AGE mean 62 (SD 8) years; SEX 80 (60%) male; FEV1 post‐bronchodilator mean 61 (SD 11)% predicted

Interventions

DURATION OF INTERVENTION 4 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION LAMA/LABA (aclidinium bromide/formoterol fumarate, 400/12 μg) dry‐powder inhaler twice daily (Genuair™/Pressair®)

PLACEBO dry‐powder inhaler twice daily (Genuair™/Pressair®)

Outcomes

DEVICE DynaPort MoveMonitor

  • Wear instructions: 7 days, 24 hours a day (except time spent on personal hygiene)

  • Data inclusion criteria: ≥ 3 days, not necessarily consecutive, > 8 hours a day

ASSESSMENT TIME POINTS

  • Baseline

  • Pre‐cross‐over: 4 weeks

PRIMARY OUTCOME

  • Other: spirometry

SECONDARY OUTCOMES

  • Physical activity: step count, MVPA time (> 3 METs), active EE (> 3 METs), % "inactive patients" (< 6000 steps a day)

  • HRQOL: not assessed

  • Exercise capacity: endurance time (cycle ergometry)

  • Adherence: not reported

  • Adverse events: reported

  • Other: spirometry, rescue medication use, physical activity (subjective)

Notes

FUNDING "Complete Medical Communications, Macclesfield, UK, for providing medical writing support, which was funded by AstraZeneca in accordance with Good Publication Practice (GPP3) guidelines. This study was sponsored by Menarini Group through its affiliate Berlin‐Chemie and AstraZeneca. Menarini Group and AstraZeneca were involved in the study design, collection, analysis, interpretation of data, and development of this manuscript. Menarini Group and AstraZeneca were also involved in the review of the manuscript."

CONFLICT OF INTEREST statement provided

CONTACT Henrik Watz [email protected] German Center for Lung Research, Grosshansdorf (Germany)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Allocation: Randomized"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

Low risk

Quote: "Masking: Double (Participant, Investigator)"

Blinding of personnel (performance bias)

Low risk

Quote: "Masking: Double (Participant, Investigator)"

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity, exercise capacity

Blinding of outcome assessment [other] (detection bias)

Low risk

N/A

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow diagram provided

Selective reporting (reporting bias)

Unclear risk

SECONDARY OUTCOMES

Paper: additional outcomes

  • step count, time in moderate intensity physical activity, active energy expenditure

  • treatment‐emergent adverse events (including AECOPD)

  • concomitant and rescue medication use

Other bias

Unclear risk

Quote: "When considering the design of the ACTIVATE study and any impact this may have had on the results, it should be noted that statistical significance for the primary end point (trough FRC) was reached only after the use of a nonparametric test or after excluding four potential outliers (the sample size was too small to overcome random error in the presence of these extreme outliers). It was unexpected that the improvements in trough FRC did not reach statistical significance, given that previous evidence showed that aclidinium 400 μg improved trough FRC in patients with moderate‐to‐severe COPD, in addition to improvements in other lung hyperinflation end points both in patients with moderate‐to‐severe COPD and in patients with severe‐to‐very severe COPD. However, when considered collectively with the post‐dose data, this post‐hoc analysis supports the conclusion that AB/FF significantly reduced lung hyperinflation. In addition to this, the 2‐month study period of ACTIVATE is too short to show long‐term treatment effects on physical activity, considering that it can be challenging to encourage long‐term changes in physical activity in patients with COPD and that data for long‐term improvements of physical activity by bronchodilators are lacking."

Widyastuti 2018

Methods

DESIGN 2 groups

DATES October 2016 to January 2017

SETTING hospital outpatient clinic (Indonesia)

SAMPLE SIZE calculation based on 6MWT

Participants

INCLUSION CRITERIA

  • Diagnoisis of COPD (GOLD guidelines)

  • Age 40 to 75 years

  • Stable clinical condition (no AECOPD within 4 weeks)

EXCLUSION CRITERIA

  • PR within 6 months

  • Severe concomitant comorbidities such as ischaemic cardiac disease, chronic heart failure, orthopedic and/or neuromuscular diseases interfering with their ability to walk

MEDICATION "Patients maintained their usual drug medication during the entire study"

BASELINE CHARACTERISTICS (total n = 40)

  • INTERVENTION: PAC (n = 18)

AGE mean 68 (7) years; SEX 16 (89%) male; FEV1 mean 1.1 (SD 0.5) litres

  • INTERVENTION: exercise training (n = 18)

AGE mean 61 (7) years; SEX 15 (83%) male; FEV1 mean 0.9 (SD 0.4) litres

Interventions

DURATION OF INTERVENTION 6 weeks

FOLLOW‐UP no

SUPERVISION no

INTERVENTION PAC (in‐person)

DURATION 6 weeks

INTERFACE

  • 1 meeting at home a week

  • 1 meeting at outpatient clinic every 2 weeks

ACTIVITY walking ≥ 30 minutes a day, fastest pace possible

STEP‐TRACKING pedometer

RECORD daily log book: step count, change in clinical condition

GOALS aim > 6500 steps a day

  • PROGRESSION weekly 10% increase

EDUCATION/RESOURCES nil

INTERVENTION exercise training

DURATION 6 weeks

SETTING centre‐based supervised outpatient

CONTACT 3 sessions a week, 30 minutes

AEROBIC TRAINING treadmill

  • INITIAL PRESCRIPTION 80% of baseline 6MWT average speed

  • PROGRESSION speed increased by 0.1 kph a session

OTHER COMPONENTS Encouraged to be more active at home (i.e. no goals)

  • Walk ≥ 30 minutes daily without supervision

  • Activity log book: daily step count, checked each week

STRENGTH TRAINING, EDUCATION nil

Outcomes

DEVICE Omron HJ 321 (pedometer)

  • Wear instructions/data inclusion criteria: "given a pedometer on the day before the first session and the day after the last session in order to record the daily steps"

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 6 weeks

PRIMARY OUTCOME

  • Exercise capacity: 6MWD

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: CAT

  • Adherence: not reported

  • Adverse events: not reported

  • Other: dyspnoea

Notes

FUNDING not reported

CONFLICT OF INTEREST statement provided

CONTACT Kiki Widyastuti [email protected] Dr Moewardi Hospital, Central Jawa (Indonesia)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Patients were randomly assigned"

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants (performance bias)

High risk

Quote: "Patients were not blind to treatment"

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Unclear risk

Physical activity: unclear if step count data was reported by participants

Blinding of outcome assessment [other] (detection bias)

High risk

HRQOL and exercise capacity:

Quote: "researchers evaluating results and patients were not blind to treatment"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

CONSORT diagram provided

Selective reporting (reporting bias)

Unclear risk

No trial registry; results presented as in Methods

Other bias

Unclear risk

Quote: "During the first week, all patients were taught how to use pedometers in three face to face sessions with a researcher checking patients’ ability to use the device properly. After the training week, subjects were randomly assigned to two groups." Comment: unclear if this was the same week as baseline data collection

Wootton 2017

Methods

DESIGN

Phase 1 2 groups (intervention (supervised walking training) vs. no intervention)

Phase 2 supervised walking training group from Phase 1 randomised into 2 groups (intervention (PAC and pedometer with walking) vs. intervention (walking))

DATES May 2009 to June 2012

SETTING 5 sites, outpatient PR, 2 metropolitan cities (Australia)

SAMPLE SIZE

Phase 1: calculation based on CRQ

Phase 2: calculation based on total SGRQ score at the 14‐month assessment

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (moderate, severe or very severe; FEV1 > 80% predicted, FER < 0.7)

  • Smoking history > 10 pack‐years

  • Stable clinical state

EXCLUSION CRITERIA

  • LTOT

  • BMI > 35 kg/m2

  • Use of walking aid

  • Comorbidities likely to adversely affect exercise performance

  • Participation in supervised exercise training within 12 months

BASELINE CHARACTERISTICS

Phase 1

  • INTERVENTION exercise training (ground‐based walking) (n = 95)

AGE mean 69 (SD 8) years; SEX 56 (59%) male; FEV1 mean 43 (SD 15)% predicted

  • NO INTERVENTION (n = 48)

AGE mean 68 (SD 9) years; SEX 28 (58%) male; FEV1 mean 43 (SD 15)% predicted

Phase 2 (participants from the intervention group in phase 1)

  • INTERVENTION PAC with pedometer (n = 49)

AGE mean 70 (SD 7) years; SEX 25 (51%) male; FEV1 mean 43 (SD 15)% predicted

  • NO INTERVENTION (n = 46)

AGE mean 69 (SD 9) years; SEX 30 (65%) male; FEV1 mean 43 (SD 15)% predicted

Interventions

DURATION OF INTERVENTION 8 weeks exercise training, 12‐month maintenance period

FOLLOW‐UP no

SUPERVISION Phase 1 supervised, Phase 2 unsupervised

Phase 1

INTERVENTION exercise training (ground‐based walking) with follow‐up advice

SETTING centre‐based outpatient group, supervised

CONTACT 3 sessions a week (20 sessions within 8 to 10 weeks)

AEROBIC TRAINING walking, flat indoor track

    • INITIAL PRESCRIPTION 30 minutes, 80% of baseline 6MWT average speed

    • PROGRESSION every 6th session, 5 minutes (maximum 45 minutes)

    • TRAINING INTENSITY "walk at a pace which elicited a dyspnoea score of 3–4 on a modified 0–10 point dyspnoea scale"; weight belts if speed could not be increased (starting weight 2.5 kg, increase 1 kg after every 3rd session)

STRENGTH TRAINING, OTHER COMPONENTS, EDUCATION nil

  • FOLLOW‐UP STAGE Common component: both groups asked to complete a further 12 months of home‐based training; written instructions to walk for 45 minutes on at least 3 days each week, a scoring system for self‐assessment of breathlessness and effort, and a weekly diary card to record the number of days of walking training each week and the total number of minutes walked each week

SETTING home‐based

CONTACT telephone

    • First 3 months: every fortnight

    • Last 9 months: monthly

AEROBIC TRAINING adjusted according to the number of steps achieved in the past 2 training sessions

NO INTERVENTION

medical management optimised at baseline, including individualised COPD action plan; "did not participate in any exercise training and were not given any instructions regarding exercise"

Phase 2

Participants in the intervention group in phase 1 were asked to complete a further 12 months of home‐based walking

SETTING home‐based

ACTIVITY walk ≥ 3 days a week

  • duration: 45 minutes (registry); same duration achieved in the final week of supervised training (paper)

  • pace: modified Borg scale dyspnoea (rating 3 to 4)

RECORD weekly diary card (number of days, number of minutes walked)

EDUCATION/RESOURCES written instructions, scoring system for self‐assessment of breathlessness and effort

INTERVENTION PAC and pedometer

INTERFACE

  • initial individual education and motivation session

  • phone calls month 1 to month 3, fortnightly; month 3 to month 12, monthly

STEP‐TRACKING pedometer (G‐Sensor accelerometer, direct feedback)

GOALS based on step count (immediate past 2 training sessions)

Outcomes

DEVICE SenseWear® Pro3 (software version 6.1)

  • Wear instructions: 7 days, 24 hours a day (remove for showering or bathing)

  • Data inclusion criteria: ≥ 3 days, ≥ 20 hours a day

ASSESSMENT TIME POINTS

  • Baseline: pre‐Phase 1

  • 8 weeks: end Phase 1, pre‐Phase 2

  • 8 months: mid‐Phase 2 (6 months)

  • 14 months: end Phase 2 (12 months)

PRIMARY OUTCOME

  • HRQOL: SGRQ, CRQ

  • Physical activity: step count, sedentary time (< 1.5 METs), LIPA time (1.5 to < 3 METs), MVPA time (≥ 3 METs), total EE

SECONDARY OUTCOMES

  • Exercise capacity: 6MWD, ISWD, ESWT

  • Adherence: reported

  • Adverse events: reported

Notes

FUNDING reported

CONFLICT OF INTEREST statement provided

CONTACT Sally Wootton [email protected] University of Sydney (Australia)

Additional results provided: physical activity and exercise capacity

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "This study was a prospective, blinded (assessor and statistician), multicentre, randomised controlled trial with concealed allocation. Following baseline assessment participants were randomised via an independent telephone randomisation service using computerised random number generator sequencing to either the walking group or control group. Randomisation was stratified according to baseline lung function, SGRQ, 6MWD and study centre. Randomisation was biased towards the walking group with a 2:1 ratio for the purposes of a long‐term follow‐on study to 12 months."

Allocation concealment (selection bias)

Low risk

Quote: "concealed allocation… following baseline assessment participants were randomised via an independent telephone randomisation service"

Blinding of participants (performance bias)

High risk

Unable to blind participants to the intervention

Blinding of personnel (performance bias)

Unclear risk

Not specified

Blinding of outcome assessment [objective] (detection bias)

Low risk

Physical activity

Blinding of outcome assessment [other] (detection bias)

Low risk

HRQOL and exercise capacity:

Quote: "assessor blinded"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Lack of clarity on participant numbers

Selective reporting (reporting bias)

Unclear risk

Physical activity results not reported at 8 months (as in registry)

Other bias

Unclear risk

Quote: "Retrospectively registered" (as per www.anzctr.org.au)

ACE: angiotensin‐converting enzyme; AECOPD: acute exacerbation of COPD; BMI: body mass index; CAT: COPD assessment test; CCQ: clinical COPD questionnaire; COPD: chronic obstructive pulmonary disease; COPEactive: community‐based physiotherapeutic exercise programme; cpm: counts per minute; CRQ: chronic respiratory disease questionnaire; CT: computerised tomography; ECG: electrocardiogram; EE: energy expenditure; ESWT: time walked on endurance shuttle walk test; EQ5D: EuroQol 5 dimensions questionnaire; FER: forced expiratory ratio; FEV1: forced expiratory volume in 1 second; FRC: functional residual capacity; GOLD: Global Initiative for Chronic Obstructive Lung Disease; HIIT: high‐intensity interval training; HRmax: maximum heart rate; HRQOL: health‐related quality of life; ICD‐10: International Statistical Classification of Diseases and Related Health Problems 10th Revision; ICS: inhaled corticosteroid; ISWD: distance walked on incremental shuttle walk test; ITT: intention‐to‐treat; IQR: interquartile range; LABA: long‐acting beta2 agonist; LAMA: long‐acting muscarinic antagonist; LIPA: light‐intensity physical activity; LTOT: long‐term oxygen therapy; MRC: Medical Research Council; METs: metabolic equivalents; min: minutes; MVPA: moderate‐to‐vigorous physical activity; n: number; NIPPV: non‐invasive positive pressure ventilation; 1RM: one repetition maximum; PAC: physical activity counselling; PaCO2: partial pressure of carbon dioxide; PAL: physical activity level; PaO2: partial pressure of oxygen; Pimax: maximal inspiratory pressure; PR: pulmonary rehabilitation; RAND‐36: Dutch version of SF36; RV: residual volume; sec: seconds; SF36: Medical Outcomes Survey 36‐item short‐form health survey questionnaire; SGRQ: St George's respiratory questionnaire; 6MWD: distance walked on six‐minute walk test; 6MWT: six‐minute walk test; SD: standard deviation; SEM: standard error of measurement; SPACE: self‐management programme of activity, coping and education; SpO2: peripheral oxygen saturation; TLC: total lung capacity; VMU: vector magnitude unit; Wmax: maximum work rate.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

ACTRN12611001034921

study not completed/withdrawn from registry

Aksu 2006

physical activity not objectively assessed outcome

Arnedillo 1998

physical activity not objectively assessed outcome

Atkins 1984

physical activity not objectively assessed outcome

Barnes‐Harris 2019

physical activity not objectively assessed outcome

Bartlett 2017

physical activity not objectively assessed outcome

Baumann 2006

physical activity not objectively assessed outcome

Behnke 2000

physical activity not objectively assessed outcome

Behnke 2005

not randomised

Bernardi 2017

not randomised

Bertici 2013

not randomised

Biscione 2009

physical activity not objectively assessed outcome

Bohning 1990

physical activity not objectively assessed outcome

Boland 2015

physical activity not objectively assessed outcome

Borges 2012

observational

Bourbeau 2000

physical activity not objectively assessed outcome

Budnevskiy 2015

physical activity not objectively assessed outcome

Bunker 2012

physical activity not objectively assessed outcome

Bustamante 2013

tried to contact author: no physical activity data presented

Börekçi 2008

physical activity not objectively assessed outcome

Camillo 2011

physical activity not objectively assessed outcome

Cebollero 2018

not randomised

Chen 2018

physical activity not objectively assessed outcome

Corrado 1995

physical activity not objectively assessed outcome

Coultas 2011

physical activity not objectively assessed outcome

Coultas 2017

physical activity not objectively assessed outcome

De Backer 2014

physical activity not objectively assessed outcome

De Souza 2017

physical activity not objectively assessed outcome

Deering 2011

Quote: "a complete control group was not possible; therefore, the control group in the present study was monitored on 2 separate occasions 8 weeks apart, and then randomized to either the rehabilitation group or acupuncture and rehabilitation"

Durheim 2015

no group comparison

Dyer 2011

physical activity not objectively assessed outcome

EUCTR2016‐003675‐21‐ES

physical activity not objectively assessed outcome

Faulkner 2010

physical activity not objectively assessed outcome

Fernandez 1998

physical activity not objectively assessed outcome

Foy 2006

attempted to contact author: no objective physical activity outcomes published

Friis 2017

attempted to contact author: unable to obtain pre‐cross‐over data

Furness 2014

physical activity not objectively assessed outcome

Garcia Aymerich 2016

secondary analyses

Gohl 2004

physical activity not objectively assessed outcome

Gohl 2006

physical activity not objectively assessed outcome

Gomez 2006

physical activity not objectively assessed outcome

Gosselink 1990

physical activity not objectively assessed outcome

Grabenhorst 2013

physical activity not objectively assessed outcome

Greulich 2013

physical activity not objectively assessed outcome

Guell 2008

physical activity not objectively assessed outcome

Gurgun 2011

physical activity not objectively assessed outcome

Hartman 2012

observational

Hataji 2017

not randomised

Herrejon 2010

physical activity not objectively assessed outcome

Hillegass 2012

physical activity not objectively assessed outcome

Horton 2018

physical activity not objectively assessed outcome

Ichinose 2017

contacted author: unable to obtain pre‐cross‐over data

Ides 2012

physical activity not objectively assessed outcome

Innocenti 2000

physical activity not objectively assessed outcome

Johnson‐Warrington 2016

physical activity not objectively assessed outcome

Jonsdottir 2015

physical activity not objectively assessed outcome

Kato 2017

attempted to contact author: no physical activity data for control group

Kim 2003

physical activity not objectively assessed outcome

Kruis 2014

physical activity not objectively assessed outcome

Langer 2018

physical activity listed as objectively assessed outcome in registry, no results reported in paper

Larraz 2010

physical activity not objectively assessed outcome

Lee 2007

physical activity not objectively assessed outcome

Liang 2018

physical activity not objectively assessed outcome

Liu 2019

physical activity not objectively assessed outcome

Lum 2007

physical activity not objectively assessed outcome

Mahesh 2017

physical activity not objectively assessed outcome

Marques 2019

not randomised

Martinez 2008

physical activity not objectively assessed outcome

McGlone 2006

observational

McMahon 2000

attempted to contact author: unable to obtain pre‐cross‐over data

Mesquita 2017

no group comparison

Moore 2009

observational

Morris 2012

not randomised

Moy 2009

observational

Moy 2012

observational

Murphy 2005

physical activity not objectively assessed outcome

Nagata 2018

attempted to contact author: unable to obtain pre‐cross‐over data

NCT00620022

contacted author; unable to access pre‐cross‐over data from Novartis

NCT01012765

author correspondence: pre‐cross‐over data not available

NCT01380652

author correspondence: physical activity not objectively assessed outcome

NCT01486186

physical activity not objectively assessed outcome

NCT01722370

author correspondence: pre‐cross‐over data not available

NCT01854008

physical activity not objectively assessed outcome

NCT01867970

author correspondence: unable to obtain results just for participants with COPD

NCT01871025

physical activity not objectively assessed outcome

NCT02100709

study not completed/withdrawn from registry

NCT02172794

physical activity not objectively assessed outcome

NCT02629965

not randomised

NCT02656667

physical activity not objectively assessed outcome

NCT03751670

physical activity not objectively assessed outcome

NL1729

author correspondence: study ceased soon after trial registration, no data

Norweg 2006

physical activity not objectively assessed outcome

Nyberg 2017

not randomised

Paneroni 2016

physical activity not objectively assessed outcome

Pasqua 2010

physical activity not objectively assessed outcome

Pinnock 2013

physical activity not objectively assessed outcome

Pitta 2008

observational

Pomidori 2012

no group comparison

Raphael 2014

physical activity not objectively assessed outcome

Ringbaek 2009

physical activity not objectively assessed outcome

Robbins 2000

physical activity not objectively assessed outcome

Rodriguez‐Trigo 2011

physical activity not objectively assessed outcome

Romagnoli 2005

physical activity not objectively assessed outcome

Roman 2013

physical activity not objectively assessed outcome

Schacher 2006

physical activity not objectively assessed outcome

Schönhofer 1997

observational

Senthilnathan 2018

physical activity not objectively assessed outcome

Sewell 2005

physical activity not objectively assessed outcome

Sewell 2010

no group comparison

Sirichana 2013

no group comparison

Soicher 2009

physical activity not objectively assessed outcome

Spencer 2012

no group comparison

Steele 2008

author correspondence: unable to obtain results just for participants with COPD

Strijbos 1991

physical activity not objectively assessed outcome

Sutanto 2018

physical activity not objectively assessed outcome

TCTR20170214002

physical activity not objectively assessed outcome

Troosters 2010

observational

Troosters 2011

no group comparison

Tse 2013

physical activity not objectively assessed outcome

Turnbull 2013

attempted to contact author: unable to obtain results just for participants with COPD

Turner‐Lawlor 2005

physical activity not objectively assessed outcome

U1111‐1169‐0718

not randomised

UMIN000001833

attempted to contact author: unable to determine if randomised

Valenson 2016

not randomised

Voncken‐Brewster 2013

physical activity not objectively assessed outcome

Wilson 2015

physical activity not objectively assessed outcome

Zanini 2002

physical activity not objectively assessed outcome

Characteristics of ongoing studies [ordered by study ID]

ACTRN 12616000360415

Trial name or title

Telerehabilitation versus traditional centre‐based PR for people with chronic respiratory disease: protocol for a randomised controlled trial (REACH)

Methods

DESIGN 2 groups, equivalence trial; COMPARISON intervention vs. intervention; SETTING Alfred Health and Austin Health (metropolitan, Melbourne), Wimmera Health Care Group (regional, Horsham) (Australia); SAMPLE SIZE n = 142 (based on CRQ dyspnea domain)

Selection bias: "Participants will be randomly allocated (1:1) …. A computer‐generated, block randomisation scheme will be used with stratification …. Sequence generation will be performed by an individual who is independent of the research team and randomisation will occur using an online database. The randomisation sequence will be concealed from investigators"; Performance bias: "Given the nature of the intervention (exercise training) participants will not be blinded to the intervention", also personnel; Detection bias: "assessor‐blinded"

Participants

Primary diagnosis of a chronic lung disease (COPD, bronchiectasis, asthma, ILD); age ≥ 40 years

Interventions

DURATION OF INTERVENTION 8 weeks

COMMON COMPONENTS

Protocol for exercise training prescription and progression

Disease‐specific education and collaborative self‐management training

  • education resources

  • long‐term exercise planning, education on identifying and managing an acute exacerbation

  • additional topics relating to self‐care e.g. airway‐clearance techniques, maintaining a healthy diet where participants identify a relevant health goal

OTHER COMPONENTS encouraged to perform an additional 3 unsupervised sessions each week, home diary reviewed weekly; encouraged to continue with a regular exercise regimen following programme completion

INTERVENTION Telerehabilitation

SETTING home‐based, remotely supervised, groups of 4 to 6 participants

    • step‐through exercise bike

    • tablet computer with a stand

    • pulse oximeter

    • videoconferencing (to enable participants to see and speak to each other)

CONTACT

    • initial home visit

    • 2 sessions a week

AEROBIC TRAINING cycle training, 30 minutes, ≥ 2 bouts

    • INITIAL PRESCRIPTION 60% VO2 (CPET)

    • PROGRESSION weekly, increase 5% to 10%, based on symptoms

STRENGTH TRAINING use equipment readily available in the home environment

    • INITIAL PRESCRIPTION 3 sets, 8 to 12 repetitions, progressed accordingly

INTERVENTION Centre‐based PR

SETTING outpatient, groups of 8 to 12 participants

CONTACT 2 sessions a week

AEROBIC TRAINING cycling and walking, 30 minutes, ≥ 2 bouts

    • INITIAL PRESCRIPTION walking (70% to 80%: 6MWT speed), cycle ergometer (60% VO2::CPET)

    • PROGRESSION weekly, modified Borg scale dyspnoea (rating three to four), walking (0.25 or 0.5 km/hour depending on initial training speed), cycle (increase 5% to 10%)

STRENGTH TRAINING use equipment readily available in the home environment

    • INITIAL PRESCRIPTION 3 sets, 8 to 12 repetitions, progressed accordingly

Outcomes

DEVICE GeneActiv (wrist), Wear instructions: 7 days

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 8 weeks

  • Follow‐up: 12 months

PRIMARY OUTCOME HRQOL: CRQ dyspnoea domain

SECONDARY OUTCOMES

  • Physical activity: sedentary, LIPA time, MVPA time

  • HRQOL: CRQ other domains, SF36

  • Exercise capacity: 6MWD, endurance cycle time

  • Adherece: attendance rates at training sessions (programme completion ≥ 70% of planned sessions)

SAFETY "The trial will be monitored by an independent Data Safety Monitoring Board (DSMB) comprising a respiratory physician and two clinical research physiotherapists, with consultation with a statistician as required. The DSMB will review data relating to the primary outcome (CRQ‐D) as well as 6MWD, endurance cycle time and Hospital Anxiety and Depression Scale scores. Data will be presented to the DSMB in a blinded fashion. The DSMB will initially review data at a time 6 months from the commencement of recruitment. Any serious adverse events will be notified immediately to the overseeing ethics committee (Alfred Health) and the relevant site governance committee, as well as to the DSMB. If there are concerns about the safety of participants, the DSMB will make a recommendation to the trial steering committee about continuing, stopping, or modifying the trial."

Starting date

Prospectively registered; recruitment commenced August 2016; last participant enrolment January 2019

Contact information

Narelle Cox [email protected] La Trobe University, Melbourne (Australia)

Notes

FUNDING "This study is funded by a National Health and Medical Research Council (NHMRC) project grant (GNT1101616). NSC is supported by an NHMRC Early Career Fellowship (GNT 1119970). The NHMRC will not interfere with the independence of the authors in regard to the conduct of the trial and will not delay or prevent publication of the study"

N.B. will need data only for COPD participants for inclusion

ACTRN12615000121561

Trial name or title

Effect of opioids on outcomes of PR: a randomised, double‐blind, multi‐site, parallel arm, fixed dose, placebo‐controlled trial of the effects of morphine on exercise capacity and other outcomes of PR in COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 260 (based on 6MWD)

Selection bias: "schedules have been developed by an organisation not involved in this study... block randomisation schedule held by the Central Registry Clinical Trials Pharmacist"; Blinding: participants, personnel and outcome assessors

Participants

Diagnosis of COPD (post‐bronchodilator FER < 0.7); Age ≥ 18 years; modified MRC dyspnoea scale (score 3 or 4); Stable medications for breathlessness for 1 week; Eligible for PR as judged by the treating physician and the investigator

Interventions

DURATION OF INTERVENTION 8 weeks

INTERVENTION morphine and PR

oral sustained‐release morphine 20 mg in the morning and 2 capsules of blinded laxative

INTERVENTION placebo and PR

oral placebo capsule and 2 capsules of placebo laxative

Outcomes

DEVICE (accelerometer)

PRIMARY OUTCOME Exercise capacity: 6MWD

SECONDARY OUTCOMES

  • Physical activity: [not defined]

  • HRQOL: CRQ, EQ5D, CAT

  • Adherence: PR, medication

  • Adverse events

Starting date

Prospectively registered; last participant enrolment September 2017; final recruitment n = 10; "stopped early: participant recruitment difficulties; data collected is being analysed"

Contact information

David Currow [email protected] Flinders University, Adelaide (Australia)

Notes

FUNDING Commonwealth Department of Health

ACTRN12616001534471

Trial name or title

A behaviour‐change intervention to reduce sedentary time in people with COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. sham; SETTING PR waiting lists, Royal Prince Alfred Hospital and Prince of Wales Hospital, Sydney (Australia); SAMPLE SIZE n = 70 (based on sedentary time)

Participants

Diagnosis of COPD (FER < 0.7); clinically stable (no change in medication within 4 weeks); can mobilise independently with or without a walking aid; expected to wait ≥ 8 weeks for PR

Interventions

DURATION OF INTERVENTION 6 weeks

INTERVENTION PAC (behaviour change)

INTERFACE weekly

  • Weeks 1, 3 and 6: face‐to‐face session, 1 hour

  • Other weeks: phone calls, up to 30 minutes

GOALS 2 target behaviours

  • Replace sitting and lying down with LIPA where possible

  • Stand up and move for 2 minutes after 30 minutes of continuous sedentary time

ACTIVITY TRACKING Jawbone UP3 (wrist), all waking hours, real‐time feedback on prolonged bouts of sedentary time, vibrate after 30 minutes of sustained inactivity

CONTENT

    • Motivational interviewing, problem‐solving of barriers

    • Information re health consequences of sedentary behaviour

    • Workbook: weekly, goals and action plan

SHAM No instructions about physical activity or exercise

CONTACT weekly phone calls, 15 minutes

CONTENT Enquire about change in health status, directed to contact their local doctor if they have any health issues

Outcomes

DEVICE activPAL3, Wear instructions: 7 days, 24 hours a day (remove if skin irritation)

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 6 weeks

  • Follow‐up: 12 weeks following progamme completion

PRIMARY OUTCOME Physical activity: sedentary time, number of bouts of sedentary time (> 30 minutes), number of sit‐to‐stand transitions

SECONDARY OUTCOMES

  • HRQOL: SGRQ

  • Exercise capacity: 6MWD

Starting date

Anticipated to begin February 2017, complete March 2019

Contact information

Zoe McKeough [email protected] University of Sydney (Australia)

Notes

FUNDING "This research study is supported by a Physiotherapy Research Foundation Seeding Grant (2016). The principal researcher Sonia Cheng is supported by a Better Breathing Foundation scholarship."

CONFLICT OF INTEREST "The authors have no conflicts of interest."

ACTRN12616001586404

Trial name or title

Effect of a PR programme of 8 weeks duration compared to 12 weeks on exercise capacity in people with COPD (PuRe Duration): a randomised controlled trial

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 68 (based on ESWT)

Selection bias: "will be determined using a computer‐generated randomisation program with a minimisation algorithm... completed for each consenting participant by a person independent of the study"; Blinding: outcome assessor, data analysts

Participants

Diagnosis of COPD (FEV1 20% to 80% predicted, FER < 0.7); age 40 to 85 years; referred to PR

Interventions

COMMON INTERVENTION PR

SETTING outpatient, hospital

CONTACT 2 sessions a week, 60 to 90 minutes

AEROBIC TRAINING

  • INITIAL PRESCRIPTION

    • Walking (overground or treadmill): 80% of baseline 6MWT peak speed, up to 15 minutes

    • Cycling: 60% peak work rate (equation based on 6MWT)

  • PROGRESSION increase to 20 to 30 minutes between Week 2 to Week 4, modified Borg scale dyspnoea and fatigue (rating 3 to 4)

  • Arm ergometry 10 minutes

STRENGTH TRAINING upper and lower limbs (3 sets, 8 to 10 repetitions)

INTERVENTION PR (12 weeks)

INTERVENTION PR (8 weeks)

Outcomes

DEVICE Actigraph and ActivPAL, Wear instructions: 1 week

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 7 weeks

  • End intervention: 8 or 12 weeks

  • Follow‐up: 6 months post‐intervention; 12 months post‐intervention

PRIMARY OUTCOME Exercise capacity: ESWT

SECONDARY OUTCOMES

  • Physical activity: (not defined)

  • HRQOL: SGRQ, CAT

  • Adherence: attendance

Starting date

Prospectively registered; first participant enrolment February 2017

Contact information

Joshua Bishop [email protected] Balmain Hospital, Sydney (Australia)

Notes

ACTRN12617000242325

Trial name or title

Does Tai Chi increase cerebral and peripheral oxygenation and do these changes relate to improved cognitive and physical performance in people with COPD? A randomised controlled trial

Methods

DESIGN 3 groups; COMPARISONS intervention vs. intervention, intervention vs. no intervention; SAMPLE SIZE n = 66

Selection bias: "sealed opaque envelope"; Blinding: outcome assessors, data analysts

Participants

Diagnosis of COPD (GOLD stage ≥ II: FEV1 < 80% predicted; FER < 0.7); age ≥ 55 years

Interventions

DURATION OF INTERVENTION 12 weeks

COMMON INTERVENTION Exercise and Tai Chi groups

SETTING outpatient, group of 4 to 6 participants

CONTACT 2 sessions a week, 1 hour

TRAINING warm up, exercise, cool down

accelerometer (wrist) to record physical activity, exercise log book

INTERVENTION Exercise (ergometer) modified Borg Scale (moderate intensity: rating 3 to 4)

INTERVENTION Tai Chi (sun style) advised to practice daily at home

NO INTERVENTION

Outcomes

DEVICE (accelerometer)

PRIMARY OUTCOME Exercise capacity: CPET

SECONDARY OUTCOMES

  • Physical activity: (not defined)

  • HRQOL: SGRQ

  • Exercise capacity: 6MWD

Starting date

Prospectively registered February 2017; last data collection September 2018

Contact information

Shirley Ngai [email protected] Hong Kong Polytechnic University (Hong Kong)

Notes

FUNDING Research Grants Council, University Grants Committee Secretariat

ACTRN12617000499381

Trial name or title

Randomised controlled trial of a non‐pharmacological integrated care intervention to reduce breathlessness in patients with severe or very severe COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 94 (based on CRQ)

Selection bias: "randomisation table created by computer software (i.e. computerised sequence generation)", "sealed opaque envelopes"; Blinding: personnel, outcome assessors

Participants

Diagnosis of COPD (GOLD moderate to very severe: FEV1 < 60% predicted; FER < 0.7); age ≥ 18 years; modified MRC dyspnoea scale (score ≥ 2); PR within 1 year or unwilling to attempt PR due to breathlessness

Interventions

DURATION OF INTERVENTION eight weeks

INTERVENTION range of interventions to address breathlessness

  • Individualised: breathing techniques; positions to aid breathing; hand‐held fan; relaxation and breathing strategies; pacing activities; walking programme; nutritional advice

  • Adherence with suggested interventions: assessed at weekly multidisciplinary meetings

NO INTERVENTION waitlist; basic information about COPD, assessment and correction of inhaler technique, action plan

Outcomes

DEVICE (pedometer), Wear instructions: 7 days

PRIMARY OUTCOME HRQOL: CRQ mastery domain

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: CRQ other domains, CAT

Starting date

Retrospectively registered; first participant enrolment October 2016; registered April 2017; last data collection anticipated June 2021

Contact information

John Wheatley [email protected]; Tracy Smith [email protected] Westmead Hospital, Sydney (Australia)

Notes

FUNDING HCF Research Foundation

ACTRN12617000653369

Trial name or title

Effect of cognitive behaviour therapy on anxiety, depression and breathlessness in patients with COPD: a randomised controlled trial

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 60

Selection bias: "computer‐generated randomisation table", "sealed opaque envelopes"; Blinding: personnel

Participants

Diagnosis of COPD (GOLD severe or very severe : FEV1 < 60% predicted; FER < 0.7); age ≥ 18 years; modified MRC dyspnoea scale (score ≥ 2); Completion of the Westmead Hospital Breathlessness Clinic within 9 months; HADS anxiety or depression score > 8

Interventions

DURATION OF INTERVENTION 10 weeks

INTERVENTION Cognitive behaviour therapy

CONTACT individual weekly sessions, 1 hour, experienced clinical psychologist

SETTING

  • 2 telephone sessions have been factored in, given this population is likely to suffer from ill health during the study

  • 8 sessions will be delivered over 10 weeks, allowing time to reschedule appointments

  • all efforts to be flexible with times and dates will be made by study staff to improve adherence

COMPONENTS

  • Psychoeducation: Anxiety, Depression, Cognitive Behaviour Therapy model

  • Exploring feelings of loss associated with losing their wellness role

  • Breathlessness‐related anxiety action plan

  • Optional modules: mood monitoring, fear‐based exposure, desensitisation to traumatic breathlessness‐related memories

NO INTERVENTION waitlist

Outcomes

DEVICE (pedometer) Wear instructions: 7 days

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 10 weeks

PRIMARY OUTCOME HRQOL: CRQ

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: CAT

  • Adherence: "Participants that have completed less than six sessions will be classified at treatment non‐completers"

Starting date

Prospectively registered; last participant enrolment anticipated September 2021

Contact information

John Wheatley [email protected] Westmead Hospital, Sydney (Australia)

Notes

ANZCTR12611000292976

Trial name or title

In people with COPD does PR combined with a cognitive behavioural therapy programme for the sensation of breathlessness (BREVE) compared to PR alone improve anxiety and functional exercise capacity at 1, 6 and 12 months?

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SETTING PR at Repatriation General Hospital, Adelaide (Australia); SAMPLE SIZE n = 120

Participants

Diagnosis of COPD (FEV1 < 80% predicted, FER < 0.7); referred and intend to undertake PR

Interventions

DURATION OF INTERVENTION 8 weeks

COMMON INTERVENTION PR 3 exercise sessions, 1 education session each week

INTERVENTION cognitive behavioural therapy with PR

INTERVENTION social interaction with PR

Outcomes

DEVICE Actigraph GT1X3e

ASSESSMENT TIME POINTS

  • Baseline (1 month prior to intervention)

  • Follow‐up: 1 month; 6 months; 12 months

PRIMARY OUTCOME Exercise capacity: 6MWD

SECONDARY OUTCOMES

  • Physical activity: sedentary time, MVPA time

  • RQOL: CRQ

Starting date

Prospectively registered; first participant enrolment May 2011; last participant enrolment September 2013

Contact information

Marie Williams [email protected] University of South Australia (Australia)

Notes

Physical activity assessed but no results in abstract that can be used for meta‐analysis. Publication pending.

Beekman 2014

Trial name or title

Exacerbations in patients with COPD receiving physical therapy: a cohort‐nested randomised controlled trial (protocol]) Reducing exacerbations in patients with COPD with physiotherapy (DO‐IT COPD) (registry)

Methods

DESIGN 2 groups, cohort‐nested; SETTING physical therapy practices, GPs and pulmonologists (southern districts, The Netherlands); SAMPLE SIZE n = 300 (based on exacerbation frequency)

Participants

Diagnosis of COPD (GOLD stage II to IV; post‐bronchodilator FEV1 < 80% predicted; FER < 0.7); age > 18 years; AECOPD within 56 days (defined as: unscheduled visit to general practitioner / pulmonologist, hospitalisation, course of antibiotics and/or prednisone); adequate and optimal medication (inhalation) regimen; eligible for reimbursement by health insurance companies for physical therapy (post‐bronchodilator Tiffeneau‐index < 0.6)

Interventions

"The project in total will take 5 years. During the first 2 years of the project, COPD patients will be recruited at participating physiotherapy practices. The included patients will be assigned to one of two treatment arms, and followed for 2 years by means of the COPD electronic documentation system, clinical tests and questionnaires. Duration of the treatment in both the intervention and control group will be one year."

INTERVENTION "early physical therapy" starting within 56 days of AECOPD

DURATION 1 year

SETTING outpatient, physiotherapy practices

CONTACT 2 sessions a week, one hour

AEROBIC TRAINING "high‐intensity"

  • INITIAL PRESCRIPTION endurance and/or interval training ≥ 60% maximum (CPET, 6MWD)

  • PROGRESSION modified Borg scale dyspnoea and fatigue (rating ≥ 5)

STRENGTH TRAINING upper and lower limbs

  • INITIAL PRESCRIPTION ≥ 80% 1RM

  • PROGRESSION modified Borg scale dyspnoea and fatigue (rating ≥ 5)

OTHER COMPONENTS

  • (when indicated) respiratory muscle training, breathing exercises and electrical muscle stimulation

  • > 30 minutes of moderately‐intense physical activity ≥ 5 days a week

INTERVENTION optional sham

No or very low‐intensity exercise training (if the participant insists on training; ≤ 30 minutes once a week, ≤ 15% maximum; modified Borg scale dyspnoea and fatigue (rating ≤ 2)

> 30 minutes of moderately‐intense physical activity ≥ 5 days a week

Outcomes

DEVICE Dynaport

ASSESSMENT TIME POINTS

  • Mid‐intervention: 3 weeks; 6 weeks; 12 weeks; 6 months

  • End intervention: 12 months

  • Follow‐up: 12 months post‐intervention

SECONDARY OUTCOMES

  • Physical activity: (not defined)

  • HRQOL: EQ5D, CCQ, CRQ

  • Exercise capacity: 6MWD

Starting date

Trial registered August 2009; planned start January 2008; planned completion January 2013; protocol published 2014; registry amended March 2016

Contact information

Emmylou Beekman [email protected] Maastricht University (The Netherlands)

Notes

ChiCTR1800017405

Trial name or title

Effects of PR prescription on COPD patients

Methods

DESIGN 5 groups; COMPARISONS intervention vs. intervention, intervention vs. no intervention; SAMPLE SIZE n = 100

Sequence generation: "a random sequence was generated by a simple random grouping method by a staff member who was not directly involved in the inclusion of the objects"; Allocation concealment: " opaque sealed envelope"

Participants

Diagnosis of COPD (GOLD); Age 40 to 80 years; clinically stable ≥ 4 weeks; Have not exercised regularly for ≥ 6 months before the study (≥ twice a week)

Interventions

NO INTERVENTION Conventional treatment

INTERVENTION Conventional treatment and walking

INTERVENTION Conventional treatment and PR

INTERVENTION Conventional treatment and upper‐ and lower‐extremities resistance movement

INTERVENTION Conventional treatment and upper‐ and lower‐extremities resistance movement + PR

Outcomes

PRIMARY OUTCOME Exercise capacity: (not defined)

SECONDARY OUTCOMES

  • Physical activity: (not defined)

  • HRQOL: (not defined)

Starting date

Prospectively registered; anticipated study completion November 2019

Contact information

Peijun Li [email protected] Shanghai University of Sport; Xiaodan Liu [email protected] Shanghai University of Traditional Chinese Medicine (China)

Notes

DRKS00004931

Trial name or title

"Medical Vulnerability": Impact of hospital room cooling on vulnerable patients with lung disease during periods of extreme weather (UCaHS)

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 300

Blinding: none

Participants

Diagnosis of COPD, asthma, pneumonia, lung fibrosis, or pulmonary hypertension; age ≥ 18 years

Interventions

INTERVENTION room with radiant cooling

NO INTERVENTION room without radiant cooling

Outcomes

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: CAT

Starting date

Prospectively registered; first enrolment June 2014; recruitment ongoing (registry)

Contact information

Christian Witt [email protected] Arbeitsbereich Ambulante Pneumologie der Charité Universitätsmedizin, Berlin (Germany)

Notes

FUNDING Deutsche Forschungsgemeinschaft

N.B. will need data only for COPD participants for inclusion

DRKS00010777

Trial name or title

The influence of the maintenance of physical activity on mental health of patients with occupational lung diseases after an inpatient rehabilitation in the BG clinic of Falkenstein

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 194

Blinding: none

Participants

Recognised occupational diseases; age 18 to 80 years

Interventions

INTERVENTION behaviour‐oriented exercise intervention with inpatient rehabilitation

9 sessions, 45 minutes

Influence the participant's attitude towards an active lifestyle with the help of motivational and volitional strategies e.g. action‐planning

INTERVENTION inpatient rehabilitation

Outcomes

DEVICE ActiGraphGT3x+

TIME POINTS

  • 3 weeks before the start of rehabilitation

  • 2, 6 and 12 months after rehabilitation

PRIMARY OUTCOMES Physical activity: (not defined)

SECONDARY OUTCOMES

  • HRQOL: CRQ

  • Exercise capacity: 6MWT

Starting date

Retrospective registration; first enrolment 2016; registered December 2017; recruiting complete, follow‐up continuing

Contact information

Petra Wagner petra.wagner@uni‐leipzig.de Universität Leipzig, Sportwissenschaftliche Fakultät, Institut für Gesundheitssport und Public Health (Germany)

Notes

FUNDING Deutsche Gesetzliche Unfallversicherung (Germany)

N.B. will need data only for COPD participants for inclusion, also to confirm diagnosis

EUCTR2006‐005534‐20‐GB

Trial name or title

Effect of Erdosteine on inflammatory and oxidative biomarkers in sputum and exhaled breath in patients with COPD

Methods

DESIGN 2 groups, cross‐over; COMPARISON intervention vs. placebo; SAMPLE SIZE n = 32

Blinding: double

Participants

Diagnosis of COPD (GOLD moderate and severe; FER < 0.7, FEV1 < 15% reversibility after 200 µg salbutamol); smoking history (current or former) > 10 pack‐years; age 38 to 80 years; stable COPD (no chest infection requiring antibiotics or oral steroids or both within 2 months); BMI 19 to 32 kg/m2

Interventions

INTERVENTION Erdosteine (Erdotin) oral capsule

PLACEBO

Outcomes

DEVICE (pedometer)

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: SGRQ

Starting date

Prospective registration; registered November 2007; first enrolment January 2008

Contact information

Imperial College London (UK); no details provided

Notes

Unable to identify any publications

N.B. will need pre‐cross‐over data for inclusion

EUCTR2013‐003619‐24‐ES

Trial name or title

Benefits of liquid oxygen in COPD patients without evidence of domiciliary oxygen therapy, presenting desaturation on exertion

Methods

DESIGN 2 groups, cross‐over COMPARISON intervention vs, placebo; SAMPLE SIZE n = 112

Participants

Diagnosis of COPD (GesEPOC Stadium II to IV/GOLD III to IV: FEV1 < 80%, FER < 0.7, TLC > 80% predicted); clinical stability for 1 month; optimised medical treatment; do not meet conventional criteria for LTOT (SEPAR Guide, GOLD); SpO2 < 88% on 6MWT; active life

Interventions

DURATION OF INTERVENTION 12 weeks

INTERVENTION Liquefied medicinal oxygen (Visionox ® device) Concentration number: 1 to 6

PLACEBO

Outcomes

DEVICE (accelerometer)

ASSESSMENT TIME POINT End intervention: 12 weeks

PRIMARY OUTCOME HRQOL: CAT

SECONDARY OUTCOMEs

  • Physical activity: (not defined)

  • Exercise capacity: 6MWD

  • Adherence: hours using oxygen

Starting date

Prospective registration; global end of the trial February 2019 "prematurely ended"

Contact information

Maria Rosa Güell‐Rous [email protected] Grup ROV de la Societat Catalana de Pneumologia (Spain)

Notes

FUNDING Sociedad Española de Neumología y Cirugía Torácica (Spain)

N.B. will need pre‐cross‐over data for inclusion

EUCTR2016‐001238‐89‐ES

Trial name or title

Iron deficiency in patients with COPD: impact of topping with iron carboxymaltose. FACE study; Assessment in patients with ferinject and iron deficiency COPD to improve exercise tolerance

Methods

DESIGN 2 groups COMPARISON intervention vs. placebo

Blinding: single

Participants

Diagnosis of COPD; age 45 to 80 years; clinically stable ≥ 8 weeks (no change in pharmacotherapy treatment since last antibiotics intake or systemic steroids or both for AECOPD)

Interventions

INTERVENTION ferric carboxymaltose (Ferinject 50 mg/ml) solution for injection

PLACEBO

Outcomes

DEVICE SenseWear Pro2, Wear instructions: 7 days

ASSSESSMENT TIME POINT 4 weeks

PRIMARY OUTCOME Exercise capacity: endurance time (cycle ergometer, 75%)

SECONDARY OUTCOMES

  • Physical activity: (not defined)

  • HRQOL: CAT, CRQ

Starting date

Prospective registration; first enrolment June 2016; "data collection is anticipated to be completed by the end of 2019"

Contact information

Diego Rodriguez Chiaradía [email protected] Consorci Mar Parc de Salut de Barcelona (Spain)

Notes

EUCTR2016‐001805‐18‐SE

Trial name or title

A randomised, placebo‐controlled, blinded, cross‐over, pilot study to explore safety and efficacy of NBMI treatment of patients with mild, moderate and severe COPD

Methods

DESIGN 2 groups, cross‐over; COMPARISON intervention vs. placebo; SAMPLE SIZE: n = 12

Blinding: "double blind"

Participants

Diagnosis of COPD (GOLD stages I to III; post‐bronchodilator FEV1 > 30% predicted, FER < 0.7); smoking history ≥ 10 pack‐years (ex‐smokers > 6 months); age 45 to 75 years; CAT score > 10; bronchitis with cough and sputum production during many days of the last month, and ≥ 3 months during the last year

Interventions

STUDY DURATION 14 days

INTERVENTION Emeramide (NBMI) Capsule, oral

PLACEBO

Outcomes

PRIMARY OUTCOME Adverse events: frequency and severity

SECONDARY OUTCOMES

  • HRQOL: CAT, SGRQ

  • Exercise capacity: 6MWD

EXPLORATORY OUTCOME Physical activity: (not defined)

Starting date

Prospective registration; global end of the trial May 2018

Contact information

Ragnar Klingberg [email protected] NBMI Science AB, Stockholm (Sweden)

Notes

FUNDING NBMI Science AB

N.B. will need pre‐cross‐over data

Fastenau 2014

Trial name or title

Effectiveness of a physical exercise training programme COPD in primary care: a randomised controlled trial

Methods

DESIGN 2 groups; COMPARISON intervention vs. sham; SETTING primary care, Limburg (The Netherlands); SAMPLE SIZE based on 6MWD

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (mild to moderate; post‐bronchodilator FEV1 ≥ 50% predicted; FER < 0.7)

  • modified MRC dyspnoea scale (score at least 2)

  • No AECOPD ≤ 8 weeks

  • Visiting their general practitioner because of dyspnoea, impaired exercise capacity or a reduced quality of life, or both

  • Not have ≥ 30 minutes of physical activity at moderate intensity, on ≥ 5 days a week

  • CPET prior to exercise training

EXCLUSION CRITERIA Physical exercise training programme or rehabilitation therapy in the past year, respiratory tract infections ≤ 8 weeks, serious comorbid conditions which may interfere with exercise

BASELINE CHARACTERISTICS

  • INTERVENTION exercise training (allocated n = 46, baseline physical activity data n = 29)

AGE mean 62 (SD 9) years; SEX 27 (59%) male; FEV1 mean 74 (SD 15) % predicted

  • SHAM (allocated n = 44, baseline physical activity data n = 22)

AGE mean 63 (SD 11) years; SEX 17 (39%) male; FEV1 mean 74 (SD 12) % predicted

Interventions

DURATION OF INTERVENTION four months

INTERVENTION exercise training

SETTING physiotherapy practice

CONTACT 2 supervised and 1 unsupervised training sessions a week

  • supervised: 1 to 5 participants, 60 to 90 minutes depending on group size

  • unsupervised: additional training session at home, including walking or cycling or both

AEROBIC TRAINING endurance/interval treadmill training

  • INITIAL PRESCRIPTION ≥ 75% baseline 6MWT

  • PROGRESSION modified Borg scale dyspnoea and fatigue (rating ≥ 5)

STRENGTH TRAINING upper and lower limbs (2 to 3 sets, 8 to 12 repetitions)

  • INITIAL PRESCRIPTION 60% to 80% 1RM

OTHER COMPONENTS

  • Jointly define a strategy for ≥ 30 minutes of moderately‐intense physical activities on ≥ 5 days a week

  • Breathing exercises includes a range of exercises such as active expiration, slow and deep breathing, pursed lips breathing, relaxation therapy, body positions such as forward leaning and diaphragmatic breathing

SHAM "exercise training"

SETTING physiotherapy practice

CONTACT 1 session a week, 30 minutes

TRAINING modified Borg scale dyspnoea and fatigue (rating ≤ 2)

OTHER COMPONENTS

  • Verbal advice supported by written brochure

  • advised to do ≥ 30 minutes of moderately‐intense physical activities on ≥ 5 days a week

Outcomes

DEVICE Dynaport, Wear instructions: 3 days and nights

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 4 months

  • Follow‐up: 6 months

PRIMARY OUTCOME Exercise capacity: 6MWD (30 metre corridor was not always feasible, minimal corridor length 10 metres)

SECONDARY OUTCOMES

Physical activity: step count, MVPA time, time walking, time active, movement intensity during walking, PAL

  • HRQOL: CCQ, CRQ

Starting date

Registered 2008, planned closing 2010, protocol published 2014, abstract published 2015

Contact information

Annemieke Fastenau [email protected] Maastricht University (The Netherlands)

Notes

FUNDING "The funding of this study is provided by the MUMC MOVE programme of Maastricht University, and an unconditional grant of Boehringer‐Ingelheim, the Netherlands"

CONFLICT OF INTEREST "The authors declare that they have no competing interests."

email correspondence with author: results are under preparation for publication and advised to use abstract and protocol only pending publication of results

ISRCTN11017699

Trial name or title

Histological, cellular and molecular investigation of steroid responsiveness in COPD: the HISTORIC study

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 188

Blinding: double

Participants

Diagnosis of COPD (GOLD groups B to D); smoking history (current or former) ≥ 10 pack‐years; age ≥ 40 years; no AECOPD or any respiratory infection requiring medical attention or leading to a change in medication within 4 weeks; unchanged respiratory medication regimen within 8 weeks; ≥ 1 AECOPD in previous year

Interventions

DURATION OF INTERVENTION 12 months

RUN‐IN PERIOD 6 weeks

LAMA (aclidinium 400 mcg), LABA (formoterol 12 mcg) and ICS (budesonide 400 mcg), twice daily

INTERVENTION ICS, LAMA, LABA (groups A1 and B1)

INTERVENTION placbo, LAMA, LABA (groups A2 and B2)

Outcomes

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 3 months; 6 months; 9 months

  • End intervention: 12 months

SECONDARY OUTCOME MEASURES

  • Physical activity: “movement patterns” (accelerometry)

  • HRQOL: CAT, SF36, SGRQ

  • Exercise capacity: 6MWD

  • Adverse events: "therapy‐related side effects"

Starting date

Prospective registration; overall trial end April 2021

Contact information

Daiana Stolz [email protected] University Hospital Basel (Switzerland)

Notes

FUNDING AstraZeneca

ISRCTN13899108

Trial name or title

The effectiveness of a physical activity intervention versus PR on cardiovascular risk markers for individuals with COPD: a feasibility study (PARC)

Methods

DESIGN: 3 groups; COMPARISON intervention vs. intervention, intervention vs. no intervention; SAMPLE SIZE n = 60

Selection bias: www.sealedenvelope.com

Participants

Diagnosis of COPD; age 40 to 85 years

Interventions

DURATION OF INTERVENTION 6 weeks

INTERVENTION PAC

FitBit Charge 2 (heart rate and fitness wristband); tracks activity and exercise; send data to investigators (physical activity level, intensity, time)

CONTACT send messages to participant through device

FEEDBACK/GOAL SETTING target calculation: mean of the 4 most active days plus 500 steps

  • if achieved, additional 500 steps

  • if not, median of 4 most active days plus 500 steps

INTERVENTION PR

SETTING outpatient, group

CONTACT 2 sessions a week, 2 hours

CONTENT exercise training and education

NO INTERVENTION

Outcomes

DEVICE Actigraph; Wear instructions: 1 week

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: CRQ, CAT

  • Exercise capacity: ISWT, ESWT

Starting date

Retrospectively registered; registered April 2019; study dates January 2018 to October 2020

Contact information

Sally Singh sally.singh@uhl‐tr.nhs.uk Glenfield Hospital, Leicester (UK)

Notes

FUNDING National Centre for Sport and Exercise Medicine, Loughborough University; University Hospital Leicester NHS Trust (UK)

ISRCTN15949009

Trial name or title

The role of nasal high‐flow to reduce 30‐day hospital readmissions following severe exacerbations of COPD: a mixed‐methods feasibility study: NHF Post‐AECOPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 80

Participants

Emergency hospital admission with a primary diagnosis of AECOPD to St Thomas’ Hospital, London; smoking history ≥ 10 pack‐years; age 40 to 80 years; BMI ≤ 35 kg/m2; home environment safe for visits; live in catchment area

Interventions

"followed up for 30 days after hospital discharge"

INTERVENTION nasal high‐flow device, daily

NO INTERVENTION

Outcomes

DEVICE wrist‐worn physical activity monitor; Wear instructions: measured continuously for 30‐day follow‐up period

SECONDARY OUTCOMES

  • Physical activity: (not defined)

  • HRQOL: CAT, CCQ

  • Exercise capacity: peak work

Starting date

Retrospectively registered; registered February 2019; study dates September 2018 to August 2021

Contact information

Nicholas Hart [email protected] Rebecca D’Cruz [email protected] Guy’s and St Thomas’ NHS Foundation Trust (UK)

Notes

FUNDING National Institute for Health Research (UK)

ISRCTN17942821

Trial name or title

A self‐management programme of activity coping and education ‐ SPACE for COPD(C) ‐ in primary care: the protocol for a pragmatic trial

Methods

DESIGN 2 groups COMPARISON intervention vs. no intervention; SETTING primary care, COPD registers, Respiratory Biomedical Research Unit at University Hospitals of Leicester (UK); SAMPLE SIZE n = 193 (based on CAT)

Participants

Diagnosis of COPD (GOLD)

Interventions

DURATION OF INTERVENTION 5 months

INTERVENTION SPACE for COPD(C)

SETTING group‐based, up to 10 participants, community venues, times and locations to suit participants

CONTACT 6 sessions, 2 hours

CONTENT

  • Generic self‐management skills and disease‐specific tasks

  • Managing day‐to‐day tasks, minimise symptom burden, provoke health enhancing behaviour change and enhance emotional well‐being

  • Provided with a contact number in case they have queries/unable to attend

  • Complete the exercise component of the manual at home in their own time

NO INTERVENTION "If referred to PR duing study, they will not be denied access to the programme; however, they will not be included in the final analysis due to use of 'intention‐to‐treat' analysis"

Outcomes

DEVICE SenseWear Armband [back of right arm], Wear instructions: seven days, 24 hours

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: six months

  • Follow‐up: nine months

PRIMARY OUTCOME HRQOL: CAT

SECONDARY OUTCOMES

  • Physical activity: "compliance to recommendation of ≥150 minutes of moderate intentisity physical activity per week in bouts ≥10 minutes"

  • HRQOL: CRQ, ED5D

  • Exercise capacity: ISWT ESWT

  • Adherence: sessions attendance

Starting date

Retrospective registration; start February 2015, end June 2017; preliminary results available October 2018 from trial registry; HRQOL and exercise capacity, not physical activity data

Contact information

Sally Singh Sally.Singh@uhl‐tr.nhs.uk University Hospital Leicester NHS Trust (UK)

Notes

FUNDING National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care East Midlands (UK)

ISRCTN19684749

Trial name or title

CELEB trial: Comparative effectiveness of lung volume reduction surgery for emphysema and bronchoscopic lung volume reduction with valve placement: a protocol for a randomised controlled trial

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SETTING outpatient clinics at hospital sites which have an established multidisciplinary team meeting dedicated to identifying suitable candidates for lung volume reduction (UK); SAMPLE SIZE n = 76 (based on BODE score)

Random sequence (low risk): "If the person has a CV negative lobar target for treatment they will be immediately allocated randomly to one of the treatment arms, using an online system. Randomisation will be on a 1:1 basis based on a computer‐generated random sequence with random block sizes generated by Sealed Envelope (London, UK); Allocation concealment (high risk): Patients, the study coordinator and those providing clinical care will not be blinded to treatment allocation; Blinding of participants (high risk): unable to blind participants to intervention; Blinding of personnel (low risk): Investigators and all individuals involved in trial conduct or analysis remained blinded to the randomized treatment until after data lock; Detection bias (low risk): The primary endpoint measures will be performed by staff blinded to treatment allocation and patients will be asked not to reveal this in order to reduce bias."

Participants

Diagnosis of COPD (FEV1 < 60% predicted); significant hyperinflation (TLC > 100% predicted, RV > 170% predicted); ex‐smoker > 3 months; Age ≥ 18 years; modified MRC dyspnoea scale (score ≥ 3); CT scan: intact interlobar fissures (> 90%) and heterogeneous emphysema

Interventions

INTERVENTION lung volume reduction surgery

unilateral video‐assisted thoracoscopic surgery approach intended to remove the most emphysematous area of lung

high dependency unit postoperatively, management will include attention to wound discomfort, management of chest drains and prompt mobilisation.

INTERVENTION Bronchoscopic lung volume reduction with valve placement

bronchoscopy; procedures including valve adjustment and replacement will be permitted to ensure treatment is optimised.

Outcomes

DEVICE DynaPort MoveMonitor, Wear instructions: 7 days

ASSESSMENT TIME POINTS

  • Baseline

  • Follow‐up: 3 months; 12 months

PRIMARY OUTCOME Exercise capacity: ISWD

SECONDARY OUTCOMES

  • Physical activity: (not defined)

  • HRQOL: CAT, EQ5D

Starting date

Prospectively registered; opened for recruitment in October 2016; overall trial end March 2020

Contact information

Nicholas Hopkinson [email protected] Imperial College, London (UK)

Notes

FUNDING "The study is funded by a grant to Royal Brompton and Harefield NHS Foundation Trust, from the NIHR, through the Research for Patient Benefit scheme (PB‐PG‐1014‐35051). Imperial College, London will support the reporting of this manuscript. Trial sponsor representative: Patrik Pettersson, Royal Brompton and Harefield NHS Foundation Trust (RB&HFT), Royal Brompton Hospital."

CONFLICT OF INTEREST "Royal Brompton has received reimbursement of clinical trial expenses from PneumRx, PulmonX, Olympus, Uptake Medical, Holaira and Creo Medical"

ISRCTN27860457

Trial name or title

ON‐EPIC Oral nitrate supplementation to enhance PR in COPD

Methods

DESIGN 2 groups, cross‐over (registry); COMPARISON intervention vs. intervention; SETTING Royal Brompton and Harefield NHS Foundation Trust (UK); SAMPLE SIZE total final enrolment n = 165

Blinding: double

Participants

INCLUSION CRITERIA

  • Diagnosis of COPD (GOLD stage II to IV; "clinical and spirometric")

  • MRC dyspnoea scale (score ≥ 3) or functionally limited

EXCLUSION CRITERIA

  • Clinically unstable patients (within 1 month of AECOPD)

  • Within 1 month of completing PR

  • Significant comorbidity limiting exercise tolerance

  • Significant renal impairment

  • Hypotension

  • Pregnancy

  • Use of nitrate‐based medication

  • Other reason for benefit from nitrate supplementation (ischaemic heart disease, peripheral arterial disease)

  • LTOT

BASELINE CHARACTERISTICS (n = 166, 122 completed)

AGE mean 68 (SD 10) years; SEX not reported; FEV1 mean 49 (SD 17)% predicted

Interventions

COMMON INTERVENTIONS

  • PR

DURATION 8 weeks

CONTACT 2 sessions a week

CONTENT supervised, strength and endurance training, home exercise programme

  • supplement: 140 ml, consumed 3  hours before attending each PR session

INTERVENTION Nitrate‐rich beetroot juice (containing 12.9 mmol nitrate) with PR

INTERVENTION Nitrate‐deplete beetroot juice with PR

Outcomes

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 8 weeks

PRIMARY OUTCOME Exercise capacity: ISWD

SECONDARY OUTCOMES

  • Physical activity: step count, PAL

  • HRQOL: CAT

Starting date

Prospectively registered September 2014; study dates January 2015 to April 2018; intention to publish September 2019

Contact information

Nicholas Hopkinson [email protected] Imperial College, London (UK)

Notes

FUNDING The JP Moulton Medical Foundation (UK)

N.B. need to confirm: objective assessment of physical activity for inclusion; if cross‐over study, will need pre‐cross‐over data

ISRCTN45695543

Trial name or title

Training to Improve Dyspnoea (TIDe): a randomised controlled trial to investigate the use of high frequency airway oscillations as training to relieve dyspnoea in COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. sham; SAMPLE SIZE n = 106 (based on CRQ)

Selection bias: "web‐based programme (www.sealedenvelope.com)", "randomisation will be allocated by an unblinded assessor and concealed from the patient and the outcome assessor"; Performance bias: "randomisation will be... concealed from the patient" ; Detection bias: "randomisation will be... concealed from the outcome assessor"

Participants

Diagnosis of COPD (FER < 0.7); modified MRC dyspnoea scale (score ≥ 2)

Interventions

DURATION OF INTERVENTION 8 weeks

INTERVENTION Aerosure Medic (HFAO device)

battery‐operated, dual‐action device providing oscillations at 25 Hz

flow resistance from 0 to 50 cmH2O dependent on the participant’s flow rate

inhale and exhale through a mouthpiece deeply for ≥ 5 minutes, 3 times a day

SHAM

device appears identical, valve is removed (no flow resistance or oscillations)

inhale and exhale through a mouthpiece deeply for ≥ 5 minutes, 3 times a day

Outcomes

DEVICE ActiGraph GT3X (around the waist, above right hip), Wear instructions: 7 days

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 8 weeks

  • Follow‐up: 12 weeks (CRQ, CAT only)

PRIMARY OUTCOME HRQOL: CRQ dyspnoea domain

SECONDARY OUTCOMES

  • HRQOL: CRQ, CAT

  • Exercise capacity: ISWD, ESWT

  • Adherence: self‐reported diary (> 75% treatments considered compliant)

EXPLORATORY Physical activity: (not defined)

Starting date

Retrospectively registered; study dates June 2017 to December 2020

Contact information

Enya Daynes enya.daynes@uhl‐tr.nhs.uk Glenfield Hospital (UK)

Notes

FUNDING Actegy Ltd, Bracknell (UK)

ISRCTN80279999

Trial name or title

Domiciliary application of non‐invasive positive pressure ventilation with average volume assured pressure support to subjects with COPD who remain hypercapnic following the application of non‐invasive positive pressure ventilation (NPPV) for an acute exacerbation: AVAPS‐COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 60

Participants

Diagnosis of COPD (European Respiratory Society/American Thoracic Society); age 50 to 80 years; minimum of 48 hours without NPPV after using NPPV or invasive ventilation in hospital during AECOPD; persistent hypercapnia (PaCO2 ≥ 50 mmHg, < 65 mmHg; pH > 7.32; room air)

Interventions

DURATION OF INTERVENTION 1 year

INTERVENTION Long‐term domiciliary non‐invasive positive pressure ventilation with average volume assured pressure support

ventilatory support function that dynamically determines the pressure support level, which generates the target or control level of exhaled tidal volume by producing a gradual pressure change based on the preceding several breaths

NO INTERVENTION

Outcomes

DEVICE Actiwatch

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 1 month; 3 months; 6 months

  • End intervention: 12 months

SECONDARY OUTCOMES

  • Physical activity: "intensity, amount and duration of movement"

  • Exercise capacity: 6MWD

  • HROQL: SGRQ

Starting date

Retrospectively registered; registered December 2008; first enrolment November 2008; trial end November 2010

Contact information

JL Pepin JPepin@chu‐grenoble.fr Laboratoire Exploration Fonctionnelle Cardio‐Respiratoire, Grenoble (France)

Notes

FUNDING Respironics International, Inc. (France)

email sent 23 August 2019

NCT01037387

Trial name or title

Effect of the noninvasive mechanical ventilation on the daily physical activity and the inflammatory biomarkers in stable patients with COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 50

Blinding: none

Participants

Diagnosis of COPD (post‐bronchodilator FEV1 < 45% predicted, FER < 0.7 for ≥ 6 months); smoking history > 15 pack‐years; age 45 to 75 years; clinically stable ≥ 3 months; pharmacological treatment optimised within 2 years; baseline pH 7.35 to 7.45, PaCO2 > 45 mmHg (room air)

Interventions

INTERVENTION nocturnal BiPAP (IPAP 10 to 20 cmH2O, EPAP 4 to 6 cmH2O)

NO INTERVENTION

Outcomes

PRIMARY OUTCOME Physical activity: (not defined)

SECONDARY OUTCOMES

  • HRQOL: SF36, SGRQ

  • Exercise capacity: 6MWD

  • Adverse effects

Starting date

Prospectively registered; study start December 2009; estimated study completion June 2021

Contact information

Francisco Garcia‐Rio [email protected] Hospital Universitario La Paz, Madrid (Spain)

Notes

NCT01537627

Trial name or title

Effects of a long‐term physical training programme on pulmonary and systemic aspects in patients with COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 82

Blinding: outcomes assessor

Participants

Diagnosis of COPD (GOLD); age ≥ 40 years; clinical stability (absence of AECOPD for 3 months); absence of any unstable/severe cardiac, osteoarticular or neuromuscular disorders which could limit physical activities in daily life; no participation in PR within 1 year

Interventions

DURATION OF INTERVENTION 6 months

INTERVENTION Low‐intensity training

3 sessions a week, 1 hour

Calisthenic and breathing exercises; 7 different sets; progressive degrees of difficulty

INTERVENTION High‐intensity training

3 sessions a week

Aerobic exercises (treadmill and cyclo‐ergometer) ≥ 20 minutes

  • Initial prescription 60% maximal capacity; increases weekly until 110%

Resistive exercises upper and lower limbs (3 sets, 8 repetitions)

  • Initial prescription 70% 1RM, increases weekly until 121% 1RM

Outcomes

PRIMARY (up to 4 years) Physical activity: time in activities ≥ moderate intensity

SECONDARY (up to 4 years)

  • HRQOL: CRQ

  • Exercise capacity: 6MWD, ISWT

Starting date

Retrospectively registered; first posted February 2012; study start November 2009; estimated study completion July 2018

Contact information

Fabio Pitta [email protected] Hospital Universitário Norte do Paraná, Londrina (Brazil)

Notes

Sponsor: Universidade Estadual de Londrina

NCT01539434

Trial name or title

Behavioural medicine intervention to maintain physical capacity and level of physical activity in patients with COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 100

Blinding: outcomes assessor

Participants

Diagnosis of COPD; age 40 to 80 years; participated in 12 weeks of physical training at Uppsala and Umeå university hospitals

Interventions

INTERVENTION PAC

personal meeting with the physiotherapist: advice about the value of physical activity, recommendations on how to be physically active.

motivational interviewing telephone calls

  • Month 1: weekly

  • Months 2 and 3: fornightly

  • thereafter: monthly

NO INTERVENTION

personal meeting with the physiotherapist: advice about the value of physical activity, recommendations on how to be physically active.

Outcomes

PRIMARY OUTCOME Exercise capacity: 6MWD

SECONDARY OUTCOMES

  • Physical activity: step count, energy expenditure, time in different positions

  • HRQOL: SF36, CRQ

Starting date

Actual study start September 2010; estimated study completion December 2020

Contact information

Margareta Emtner [email protected] Uppsala University, Sweden

Notes

NCT01783808

Trial name or title

Effects on exercise capacity, physical activity and quality of life using ambulatory oxygen in patients with COPD who desaturate only during exercise

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 144

Blinding: outcomes assessor

Participants

Diagnosis of COPD (post‐bronchodilator FEV1 < 80% predicted, FER < 0.7); non‐smoker (smoke‐free ≥ 6 months); age ≥ 18 years; no AECOPD within 4 weeks; PaO2 > 8 kilopascal at rest; SpO2 ≤ 88%, fall ≥ 4% during 6MWT (room air); SpO2 ≥ 92% during a walk test in self‐selected pace with supplemental oxygen

Interventions

DURATION OF INTERVENTION 6 months

COMMON INTERVENTION PAC

stimulated by a physiotherapist to be more physically active; “a behavioural medicine intervention”

INTERVENTION supplemental oxygen during physical activity with PAC

INTERVENTION PAC

Outcomes

DEVEICE (accelerometer)

PRIMARY OUTCOME Exercise capacity: 6MWD

SECONDARY OUTCOME Physical activity: “physical activity level”

OTHER OUTCOMES HRQOL: EQ5D, SGRQ, CAT

Starting date

Retrospective registration; actual study start November 2012; estimated study completion December 2020

Contact information

Margareta Emtner [email protected] Uppsala University (Sweden)

Notes

Collaborators: Umeå University, Karolinska Institutet, University of California, Los Angeles

NCT01905982

Trial name or title

The effect of reflective breathing therapy compared with conventional breathing therapy on dyspnoea, activity and parasympathetic activities in patients with COPD III to IV

Methods

DESIGN 2 groups, cross‐over; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 44

Blinding: none

Participants

Diagnosis of COPD (GOLD stage III and IV); age 50 to 75 years; inpatient rehabilitation

Interventions

INTERVENTION Conventional breathing therapy, 4 sessions, 30 minutes

INTERVENTION Reflectory breathing therapy, 2 sessions, 60 minutes

Outcomes

DEVICE Sensewear, Wear instruction: 48 hours post‐intervention

SECONDARY OUTCOMES

  • Physical activity: (not defined)

  • HRQOL: CRQ, CAT

Starting date

Prospective registration; estimated study completion March 2020

Contact information

Klaus Kennkklenn@schoen‐klinik.de Klinikum Berchtesgadener Land der Schön‐Kliniken (Germany)

Notes

N.B. will need pre‐cross‐over data for inclusion

NCT01998724

Trial name or title

Long‐term Exercise After PR (LEAP): design and rationale of a randomised controlled trial of Tai Chi

Methods

DESIGN 3 groups, participants will be enrolled in cohorts; COMPARISON intervention vs. intervention, intervention vs. no intervention; SETTING PR at Beth Israel Deaconess Medical Center, VA Boston Healthcare System, Brigham and Women's Hospital, and Boston Medical Center, as well as referrals from other sites in Massachusetts (USA); SAMPLE SIZE n = 90 (based on 6MWD)

Participants

Diagnosis of COPD (FER < 0.7 or CT evidence of emphysema); age > 40 years; Completion of standard PR ≥ 8 weeks duration within 24 weeks

Interventions

DURATION OF INTERVENTION 24‐week intervention, 1 year follow‐up

INTERVENTION Tai Chi

CONTACT total 36 classes

  • First 3 months: twice a week

  • Second 3 months: once a week

CONTENT 5 formal movements

  • includes traditional Tai Chi warm‐up

  • 4 traditional inter‐related breathing techniques

  • brief cool‐down exercise of self‐massage on the face, abdomen, flanks, and mid‐back while in a sitting position

  • Written instructions on specific Tai Chi exercises, CD and DVD to facilitate home practice ≥ 3 sessions a week for ≥ 30 minutes

INTERVENTION Group walking

CONTACT total 36 classes

  • First 3 months: 2 sessions per week

  • Second 3 months: 1 session a week

CONTENT Same approximate amount of physical activity (low to moderate aerobic exercise with gentle stretching)

  • Classes will begin with 5 minutes of gentle flexibility and lower‐limb stretching exercise

  • Walking at participants' own pace around an indoor track

  • Same intensity parameters: 60% maximum heart rate, modified Borg scale dyspnoea (rating 3 to 5)

  • Encouraged to walk/stretch outside of class ≥ 3 sessions per week for ≥ 30 minutes

NO INTERVENTION "general recommendations for exercise at home"

e.g. walking in the community, local gym, equipment at facility‐based PR programme

reommend strength training 3 to 4 sessions a week, 20 minutes

Participants are allowed to participate in the maintenance programmes of their usual PR programme

Outcomes

DEVICE Omron HJ‐720ITC (pedometer) (waist), Wear instructions: waking hours for 14 days, excluding periods of bathing or other water activities

Starting date

Retrospective registration; study start August 2012; first posted December 2013; final data collection for primary outcome measure June 2018

Contact information

Marilyn Moy [email protected] VA Boston Healthcare System (USA)

Notes

FUNDING "This study was supported by an award from the National Center for Complementary and Integrative Health, National Institutes of Health (Moy and Yeh, R01AT006358)."

CONFLICT OF INTEREST "Peter Wayne is the founder and sole owner of the Tree of Life Tai Chi Center. Peter Wayne's interests were reviewed and are managed by the Brigham and Women's Hospital and Partners HealthCare in accordance with their conflict of interest policy."

NCT02099799

Trial name or title

The effect of physical activity promotion on short‐ and long‐term outcomes in COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 185

Blinding: outcomes assessor

Participants

Diagnosis of COPD (FER < 0.70 or chest CT evidence of emphysema); Age ≥ 40 years; Medical clearance to participate in an exercise programme; Active email account and can check email at least weekly; Access to a computer with Internet connection or willing to come to use study computers; Pedometer with > 90% accuracy compared to manual counts on short clinic walk

Interventions

INTERVENTION Pedometer and PAC

Website: feedback, goal setting, educational and motivational content and community forum

NO INTERVENTION Verbal instructions and written materials about exercise

Outcomes

DEVICE (pedometer)

PRIMARY OUTCOME Exercise capacity: 6MWD

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: (not defined)

Starting date

Prospective registration; estimated study completion February 2020

Contact information

Marilyn Moy [email protected] VA Boston Healthcare System (USA)

Notes

NCT02205242

Trial name or title

BACE Trial ‐ physical activity as a crucial patient‐reported outcome in COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. placebo

Blinding: participant, care provider, investigator

Participants

Diagnosis of COPD (clinical history OR spirometry); smoking history ≥ 10 pack‐years; age ≥ 18 years; current hospitalisation for potential infectious AECOPD treated with standard therapy; history of at least 1 AECOPD during the last year (prior to the current hospital admission) with systemic steroids and or antibiotics, or both; ECG at admission

Interventions

INTERVENTION Azithromycin (oral) n = 250

Day 1 to Day 3: 500 mg azithromycin once a day; Day 4 to Day 90: 250 mg azithromycin once every 2 days

PLACEBO (oral) n = 250

Day 1 to Day 3: 500 mg placebo once a day; Day 4 to Day 90: 250 mg placebo once every 2 days

Outcomes

DEVICE Dynaport, Wear instructions: 7 days

BOTH GROUPS physical activity assessed in subgroups (n = 30 each)

Baseline (post‐discharge from hospital), 3 months, 9 months

PRIMARY OUTCOME Physical activity: step count

SECONDARY OUTCOME Physical activity: step count, time MVPA, time sedentary, time active

Starting date

Prospective registration; estimated study completion April 2018

Contact information

Wim Janssens [email protected] KU Leuven (Belgium)

Notes

Collaborator: Pro‐Active Medical Pty Ltd

NCT02398643

Trial name or title

Examine the impact of early chronic disease management education following hospital discharge in acute exacerbation of COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 150

Blinding: none

Participants

Diagnosis of COPD; age 50 to 85 years; admitted to the pulmonary ward for AECOPD

Interventions

INTERVENTION Early pulmonary education

focused education sessions by Certified Respiratory Educator within 2 weeks of discharge

NO INTERVENTION general education sessions by Certified Respiratory Educator within 1 month of discharge

Outcomes

DEVICE (accelerometer) (wrist or upper arm)

ASSESSMENT TIME POINTS

  • Baseline

  • Post‐respiratory education

  • Follow‐up: 6 months

SECONDARY

  • Physical Activity: (not defined)

  • HRQOL: CAT, SGRQ

Starting date

Prospectively registered; estimated study completion December 2019

Contact information

Brandie Walker [email protected] Lisette Machado [email protected] University of Calgary (Canada)

Notes

NCT02455206

Trial name or title

Effect of counselling during PR on self‐determined motivation towards physical activity in people with COPD – protocol of a mixed‐methods study

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SETTING outpatient PR, Canton Hospital Winterthur (Switzerland); SAMPLE SIZE n = 62

Blinding: single

Participants

Diagnosis of COPD (GOLD stages B to D); age 40 to 90 years

Interventions

COMMON INTERVENTION Pneumofit (PR)

DURATION 12 weeks

SETTING outpatient

CONTACT 3 sessions a week, 90 minutes (36 sessions)

AEROBIC TRAINING cycle ergometer or treadmill

  • Intensity: 70% to 80% peak work, 20 minutes

  • Progression: symptom scores

  • 1 session a week: Nordic walking

STRENGTH TRAINING seated

  • Intensity: 70% 1RM (2 sets, 6 to 12 repetitions)

  • Progression: increase 5% 1RM when able to perform 3 sets, > 15 repetitions

INTERVENTION PAC with PR

CONTACT Week 12 of PR

  • face‐to‐face, 5 sessions, 30 minutes

  • 2 experienced physiotherapists, independent of PR

CONTENT motivational interviewing techniques

INTERVENTION PR

Outcomes

DEVICE SenseWear Pro (upper right arm wear); Wear instructions: 7 consecutive days (remove for bathing or showering)

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks

  • Follow‐up: 24 weeks

PRIMARY OUTCOME Physical activity: step count

SECONDARY OUTCOMES

  • Physical activity: PAL, METs, total EE

  • HRQOL: CRQ

  • Exercise capacity: CPET, 6MW

  • Adherence: compliance with PR (number of sessions completed divided by the total number of sessions prescribed, minimum 24, maximum 36 sessions)

Starting date

Prospectively registered May 2015; study start October 2015, final data collection for primary outcome measure January 2020

Contact information

Anne‐Kathrin Rausch‐Osthoff [email protected] Zurich University of Applied Sciences (Switzerland)

Notes

FUNDING "This study is funded by the Swiss Lung Association. Funding includes devices (accelerometer) and some of the working hours."

CONFLICT OF INTEREST "All authors declare that they have no competing interests."

NCT02471235

Trial name or title

Short‐course PR and exacerbations and activity of COPD patients over 1 year

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention

Blinding: none

Participants

INCLUSION CRITERIA

  • AECOPD

EXCLUSION CRITERIA

  • History of asthma, lung resection or other significant pulmonary disease, PR within 24 months, terminal malignancy or intractable heart failure

BASELINE CHARACTERISTICS (TOTAL n = 136; intervention n = 68, usual care n = 68)

AGE mean 75 (SD 7) years; SEX 132 (97%) males; FEV1 mean 47 (SD 16)% predicted

Interventions

DURATION OF INTERVENTION 12 months

INTERVENTION exercise training

SETTING outpatient physiotherapy training

CONTACT

  • Training: 1 to 2 sessions a week, 2 hours, 4 to 8 sessions total

  • Phone call: every 2 weeks, case manager, provide support and reinforcement for exercise at home

NO INTERVENTION

Outcomes

DEVICE Actigraph GT3XP

ASSESSMENT TIME POINT End intervention: 12 months

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: (not defined)

  • Exercise capacity: 6MWD

Starting date

Prospectively registered; study start July 2015; study completion November 2018

Contact information

Fanny Ko [email protected] The Chinese University of Hong Kong (Hong Kong)

Notes

Need physical activity data "At 12 months, there was no change in activity measured by steps per day between the IG and UG groups" [abstract]

NCT02478359

Trial name or title

Patient‐centered physical activity coaching in COPD (Walk On!): a study protocol for a pragmatic randomised controlled trial

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; ; SETTING 14 hospitals, 16 medical services, Kaiser Permanente Southern California (USA); SAMPLE SIZE actual recruitment n = 2702 (composite primary outcome of all‐cause hospitalisations, emergency department visits, observational stays and death)

Participants

Any COPD‐related hospitalisation, emergency department visit or observational stay within 12 months; on at least a bronchodilator or steroid inhaler prior to the encounter or if not on an inhaler, previous COPD diagnosis; age > 40 years

Interventions

DURATION OF INTERVENTION 12 months

INTERVENTION PAC 'Walk On!'

Week 0 In‐person individual/group orientation visit

  • Education and skills training: importance of physical activity, what participants hoped to achieve, manage symptoms, maintaining safety, strategies to overcome personal barriers

    • paper copy of the Walk On! Patient Guide

  • Initial walking prescription as in 6MWT and average baseline step count

    • chose 1 of 2 devices (preference, internet access)

      • Omron HJ329 pedometer: on‐device display, waist

      • Tractivity accelerometer: step count data via any Internet or Blue‐tooth enabled device, ankle

  • Upper‐limb resistance exercises: study‐issued bands, 3 times a week

Month 1 ‘intensive’ weekly coaching phone calls

  • Progress physical acitivity goals, reinforce self‐care skills, support efforts to monitor activities and symptoms, assist with problem‐solving physical activity barriers, troubleshoot technology issues

Months 2 to 12

  • Automated weekly contact to query breathing, health issue(s) that interfered with physical activity, average step count; revise step goal based on personalised algorithm

  • Monthly group visits

    • light exercise (15 minutes), informal peer interactions and networking (15 minutes), didactic/skill‐building component (25 minutes)

    • topics focused on practical strategies to overcome common barriers to staying active, e.g. AECOPD, weather, motivation

NO INTERVENTION

access to all health services e.g. primary, specialty care, PR, health education and lifestyle programmes

No instructions to exercise

only informed that their medical centre is participating in a study to improve outcomes for members with COPD

Outcomes

DEVICES

  • Omron HJ329 pedometer (waist)

  • Tractivity accelerometer (ankle)

SECONDARY OUTCOMES

  • Physical activity: completely inactive (zero minutes a week), insufficiently active (1 to 149 minutes a week) or active, meeting national recommendations (> 150 MVPA minutes a week)

  • HRQOL: PROMIS‐10 Global Quality of Life, CAT

Starting date

Study start June 2015; estimated study completion December 2018

Contact information

Huong Nguyen [email protected] Kaiser Permanente, Pasadena, California (USA)

Notes

FUNDING "Funding in part by the Patient‐Centered Outcomes Research Institute, PCORI 1403‐14117, 2015–2018 to Dr. Nguyen"

NCT02557178

Trial name or title

Home‐based health management of COPD patients

Methods

DESIGN 2 groups, cross‐over; COMPARISON intervention vs. no intervention ; SAMPLE SIZE n = 166

Blinding: none

Participants

Diagnosis of COPD (GOLD stage II, III or IV); smoking history (current of former) ≥ 10 pack‐years; age ≥ 40 years, hospitalised for AECOPD

Interventions

INTERVENTION PAC: activity monitor plus health coaching

Actigraph daily during weeks 1, 9, and 17; daily steps and activity will be measured

Health coaching

NO INTERVENTION

Outcomes

DEVICE SenseWear Pro

PRIMARY OUTCOMES

  • Physical activity: step count

  • HRQOL: CRQ

Starting date

Prospective registration; actual study completion March 2019

Contact information

Sara Seifert, Minnesota Health Solutions (USA)

Notes

Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Mayo Clinic, “Minnesota HealthSolutions Corporation (MHS) proposes to develop and evaluate a program to motivate and monitor people with COPD to complete home exercise as part of PR”

N.B. will need pre‐cross‐over data for inclusion

NCT02667171

Trial name or title

COPD online‐rehabilitation versus conventional COPD rehabilitation – rationale and design for a multicenter randomised controlled trial study protocol (CORe trial)

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SETTING Respiratory and Physiotherapy Departments of 8 hospitals in the capital region of Denmark: Amager, Hvidovre, Bispebjerg, Frederiksberg, Herlev, Gentofte, Frederikssund and Hillerød University Hospitals, University of Copenhagen (Denmark); SAMPLE SIZE n = 134 (based on 6MWD)

Blinding: assessor and data analyst blinded

Participants

Diagnosis of COPD (severe or very severe; FEV1 < 50% predicted ; FER < 0.7); modified MRC dyspnoea scale (score ≥ )

Interventions

COMMON COMPNENT life with COPD, participants topics, medication, daily activity, nutrition, smoking cessation, respiratory and relaxation exercises

INTERVENTION online rehabilitation

DURATION 10 weeks

SETTING home‐based, web‐cam, group of 4 to 8 participants

CONTACT 3 sessions a week, 1 hour

EXERCISE TRAINING

  • Endurance training: 3 sessions a week, 30 minutes

    • modified Borg scale (“moderate” to “very strong” in active phases)

  • Strength training: upper‐ and lower‐limb exercises, 50% to 80% 1RM, 4 sets

    • First 2 weeks serve as a familiarisation phase

    • Progressions assessed individually from session to session

EDUCATION 25 minutes

INTERVENTION centre‐based rehabilitation

DURATION 8 to 12 weeks

SETTING outpatient, group

CONTACT 2 sessions a week, 1 to 2 hours

EXERCISE TRAINING 1 hour

  • Endurance: 20 to 30 minutes, modified Borg scale dyspnoea (rating 4 to 7)

  • Resistance: upper and lower limbs, 50% to 80% 1RM, 2 to 3 sets

EDUCATION 1 session a week, 90 minutes

Outcomes

DEVICE ActivPAL

  • Wear instructions: 5 days, 24 hours

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention

  • Follow‐up: 12 weeks post‐intervention

PRIMARY OUTCOME Exercise capacity: 6MWD

SECONDARY OUTCOMES

  • Physical activity: (not defined)

  • HRQOL: CCQ, CAT, HADS, EQ5D

  • Adherence: session attendance

Starting date

Study start March 2016, scheduled to continue until December 2017

Contact information

Henrik Hansen [email protected]; [email protected] University of Copenhagen, Copenhagen (Denmark)

Notes

FUNDING "This research project received specific grants from the Danish Lung Foundation (Charitable funding), Telemedical Center Regional Capital Copenhagen (governmental funding), TrygFonden foundation (Charitable funding). The Grants covers expenses conducting the trial, salary for project employed, and University fee for the PhD education for Henrik Hansen."

CONFLICT OF INTEREST "The authors declare that they have no competing interests."

NCT02691104

Trial name or title

Use of the SMART COPD physical activity app in PR: a randomised feasibility study

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 30

Blinding: none

Participants

Diagnosis of COPD; age ≥ 18 years; attending PR in Sheffield, Rotherham or Doncaster

Interventions

INTERVENTION PAC (app) with PR and pedometer

During PR: app and pedometer

Post‐PR: app and pedometer

  • First 4 weeks: weekly contact with physiotherapist, second 4 weeks: no contact

App and pedometer: set physical activity goals, monitor progress, provide feedback

INTERVENTION PR and pedometer

During PR: blinded pedometer

Post‐PR (8 weeks): blinded pedometer

Outcomes

DEVICE Fitbit® Charge pedometer

SECONDARY OUTCOMES

  • Physical activity: "logged by the devices (e.g. number of steps, whether goals are reached etc)"

  • HRQOL: SGRQ, EQ5D

Starting date

First posted February 2016; study start January 2016; actual study completion September 2018

Contact information

Mark Hawley [email protected] University of Sheffield (UK)

Notes

Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators: University of Sheffield, National Institute for Health Research: CLAHRC YH, The Rotherham NHS Foundation Trust, Doncaster And Bassetlaw Hospitals NHS Foundation Trust

NCT02702791

Trial name or title

Sustaining Training Effects through Physical activity (STEP): enhancing physical activity to achieve sustainable benefits in extrapulmonary consequences of COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 84

Blinding: none

Participants

Diagnosis of COPD (internationally‐accepted guidelines); smoking history (current or former) ≥ 10 pack‐years; age 40 to 80 years; completed 3 months of outpatient PR (Gasthuisberg University Hospital, Leuven, Belgium); ability to manage electronic devices (smartphone, step counter)

Interventions

DURATION OF INTERVENTION 6 months

INTERVENTION PAC (tele‐coaching) with PR

feasible goal‐setting and feedback to enhance participant's motivation and commitment

Pedometer‐based goals and tele‐coaching support

INTERVENTION PR

general advices regarding physical activity

Outcomes

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 3 months

  • End intervention: 6 months

  • Follow‐up: 3 months; 6 months

PRIMARY OUTCOME Physical activity: step count

SECONDARY OUTCOMES

  • Physical activity: time in moderate activity

  • HRQOL: (not defined)

  • Exercise capacity: functional, maximal, endurance (not defined)

Starting date

Retrospective registration; estimated study completion June 2018

Contact information

Thierry Troosters [email protected] KU Leuven (Belgium)

Notes

Collaborator: Conselho Nacional de Desenvolvimento Científico e Tecnológico

NCT02707770

Trial name or title

The role of ambulatory oxygen in improving the effectiveness of PR for COPD patients

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 20

Blinding: outcomes assessor

Participants

Diagnosis of COPD; fulfil clinical criteria for PR; exercise‐induced desaturation (fall in SaO2 ≥ 4% to ≤ 90%, or any fall < 90%) and demonstrate improvement with ambulatory oxygen

Interventions

INTERVENTION ambulatory oxygen with PR

INTERVENTION placebo with PR

Outcomes

DEVICE (pedometer

)ASSESSMENT TIME POINTS Baseline, 6 weeks, 14 weeks, 18 weeks

PRIMARY OUTCOME Exercise capacity: 6MWD

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: CRQ

Starting date

Prospective registration; actual study completion December 2017

Contact information

Vijayaragavan Padmanaban, Imperial College Healthcare NHS Trust (UK)

Notes

Collaborator: National Institute for Health Research (UK)

NCT02720822

Trial name or title

Breathlessness, Exertion And Morphine Sulfate (BEAMS) study

Methods

DESIGN "A five stage, national, multi‐site, double‐blind, parallel arm, block randomised, placebo controlled, factorial, dose increment phase III study"; COMPARISON intervention vs. placebo; SETTING 19 centres (Australia); SAMPLE SIZE n = 171

PROTOCOL "The BEAMS study will be promoted to patients with COPD that interferes with ADLs through LungNet (Lung Foundation Australia) and the Primary Health Networks in each recruitment catchment area. Potentially eligible participants will be identified and approached by both primary and secondary care clinicians at participating sites across Australia who will then refer them to the research team. Research team attendance at relevant clinics and study advertisements will help to remind clinical staff of study recruitment and encourage patients to self‐refer. Permission will be sought from consultants in charge of the care of potential participants for research staff to approach them directly. Case identification in both inpatient units and outpatient clinics will also occur following case‐note review."

Selection bias: "Randomisation will occur through the development of randomisation tables using random number tables generated by an independent provider", "Randomisation requests will take the form of receipt of a prescription for study medicines by site pharmacists. Site pharmacists will receive the next randomisation number available through telephone contact with the central registry"; Performance bias: "All research staff, treating clinicians and patients will remain blinded to the treatment allocation"

Participants

Diagnosis of COPD (post‐bronchodilator FER < 0.7); age ≥ 18 years; modified MRC dyspnoea scale (score 3 or 4); atable medications over prior week; respiratory physician‐confirmed optimisation of treatment; worst breathlessness intensity in the previous 24 hours was at least 3/10

Interventions

COMMON COMPONENTS

Written advice detailing standard therapeutic strategies for managing breathlessness

Battery‐operated, hand‐held fan and instructions for use throughout the study period as standard breathlessness management strategies

INTERVENTION sustained‐release morphine sulfate

1 double‐blind capsule in the morning (8 mg, 16 mg, 24 mg or 32 mg)

laxative (Docusate with senna)

PLACEBO 1 double‐blind capsule in the morning, placebo laxative optional

Outcomes

DEVICE FitBit Charge HR

ASSESSMENT TIME POINTS "weeks one and three of the study"

OUTCOME MEASURES Physical activity: steps per day, "activity"

SAFETY "Participant safety will remain of paramount importance throughout the study period. Rescue medication will therefore be available for participants for treatment of common opioid side effects including nausea and constipation. Opioid toxicity is defined by physician assessment of respiratory depression (≤10 breaths per minute), drowsiness, myoclonus, myosis or National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAEv4) grade ≥3 for cognitive impairment, confusion or somnolence. Signs suggestive of opioid toxicity will result in urgent physician assessment, investigation of contributing factors and treated with either opioid dose reduction or naloxone according to the severity of the toxicity and degree of respiratory compromise. Reasons for cessation of study drug or withdrawal from the study include treatment failure as defined by unacceptable side effects of NCI CTCAEv4 grade 3 that do not settle with symptomatic intervention or grade 4 or 5 harms. Participants may also be withdrawn if treatment is deemed ineffective by treating clinician, increasing breathlessness scores despite study treatment or withdrawal of participant consent."

Starting date

Study start August 2016, estimated primary completion June 2019

Contact information

David Currow [email protected] Flinders University, Adelaide (Australia)

Notes

FUNDING "This study was funded by the National Health and Medical Research Council, Australia (Grant Number APP1065571) and sponsored by Flinders University, Adelaide, Australia. The funders and study sponsors had no role in the study design and will have no role in the data collection, analysis or dissemination of study results."

CONFLICT OF INTEREST "DCC has received an unrestricted research grant from Mundipharma, is an unpaid member of an advisory board for Helsinn Pharmaceuticals and has consulted Mayne Pharma and received intellectual property payments from them. MJJ has received consulting payments from Mayne Pharma."

NCT02864420

Trial name or title

Hospital‐level care at home for acutely ill adults: a pilot randomised controlled trial

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SETTING emergency departments, academic medical centre and community hospital (USA); SAMPLE SIZE "We had limited funding and could only continue our pilot for at most 2.25 months. Thus, irrespective of enrollment, we a priori planned to stop the pilot when funds were depleted."

Selection bias: "Participants were randomized to usual care admission or home hospital admission by research study staff. Randomization was stratified by condition with randomly selected block sizes between 4 and 6", "allocation concealment via sealed envelopes"; Performance/detection bias: "Given the nature of the study, blinding of patients, study staff, and physicians was not possible"

Participants

Primary or possible diagnosis of any infection, heart failure exacerbation; AECOPD or asthma exacerbation; age ≥ 18 years; resides within 5‐mile radius; caregiver to stay for first 24 hours of admission; primary diagnosis of cellulitis, heart failure, complicated urinary tract infection, or pneumonia that requires inpatient admission

Interventions

COMMON COMPONENTS

minimum 1 daily visit from an attending general internist

2 daily visits from a home health registered nurse

additional visits as needed

Also tailored to participant need: medical meals, home health aide, social worker, physical therapist, occupational therapist

All participants had continuous monitoring of heart rate, respiratory rate, telemetry, movement, falls, and sleep by a small skin patch (physIQ, Chicago, IL; VitalConnect, San Jose, CA). Monitoring was performed through machine‐based algorithms, and clinical staff reviewed alarms

INTERVENTION "Home hospital"

could provide oxygen therapy, respiratory therapies, intravenous medications via infusion pump, in‐home radiology, and point‐of‐care blood diagnostics

Participants communicated with their home hospital team by telephone, encrypted video, and encrypted short message service

physician available 24 hours a day

NO INTERVENTION

Outcomes

DEVICE VitalConnect VitalPatch

ASSESSMENT TIME POINTS

  • Discharge

  • Follow‐up: 30 days post‐discharge

SECONDARY OUTCOMES

  • Physical activity: exertion (any movement at least as vigorous as slow walking, 0.02 g/s; steps; and upright posture) and sleep

  • Adverse events

Starting date

Prospectively registered; study start September 2016

Contact information

David Levine [email protected] Brigham and Women's Hospital, Boston (USA)

Notes

FUNDING "Partners HealthCare Population Health Management provided funding support for the home hospital clinical program. Dr. Levine received funding support from an Institutional National Research Service Award from (T32HP10251) and the Ryoichi Sasakawa Fellowship Fund. The NIH had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript."

CONFLICT OF INTEREST "The authors declare that they do not have a conflict of interest."

Author correspondence: "Please note that this was the pilot study of ˜20 patients. There are too few patients with COPD to make cuts in the data, sadly. Please note our larger study will be published soon."

NCT02895152

Trial name or title

The role of activity monitors in improving physical activity in COPD patients participating in PR

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 20

Blinding: none

Participants

Diagnosis of COPD (FER < 0.7); optimised pharmacology intervention; referred for PR

Interventions

DURATION OF INTERVENTION 7 weeks

INTERVENTION PAC with PR

wear activity monitor: weekly feedback: amount of activity, steps taken, active minutes each day, wear time

tailored advice on how to improve activity levels

INTERVENTION PR

wear activity monitor, no feedback

Outcomes

DEVICE "data recorded on the device, throughout study, up to seven weeks"

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention

  • Follow‐up: 6 months

PRIMARY OUTCOME

  • Physical activity: step count, time active

SECONDARY OUTCOMES

  • HRQOL: CAT, CRQ

  • Exercise capacity: 6MWD

Starting date

First posted September 2016; estimated study completion August 2017

Contact information

Patricia Kelly [email protected] Glenn Cardwell [email protected] Natalie Garratt [email protected] Salford Royal NHS Foundation Trust, Greater Manchester (UK)

Notes

NCT02917915

Trial name or title

The CaNadian Standardized Pulmonary Rehabilitation Efficacy Trial (CoNSPiRE)

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 200

Blinding: outcomes assessor

Participants

Diagnosis of COPD (post‐bronchodilator FER < 0.7); enrolled in PR within affiliated sites or satellite tele‐health programme; as part of standard rehabilitation referral procedures; ambulatory, no unstable cardiovascular disease

Interventions

COMMON INTERVENTION PR

DURATION 6 or 8 weeks

SETTING centre‐based or tele‐rehabilitation

CONTACT 2 days a week

CONTENT 2 hours of exercise training (aerobic and resistance), 1 hour of education designed to promote self‐management

INTERVENTION traditional educational approach with PR

CONTACT

  • group sessions: lecture‐style approach

  • 1‐on‐1: education about dyspnoea management/pacing, inhaler technique, exercise maintenance

CONTENT exercise, anatomy, pulmonary diseases, healthier breathing, pulmonary medications, pulmonary devices, exercise action plan, allergies and pulmonary function tests, health and air quality, healthier eating, travel, stress management

INTERVENTION new Canadian standardised educational approach with PR

CONTACT

  • group sessions: active, participatory‐based learning, workbooks

  • 1‐on‐1: motivational communication style

CONTENT exercise, living well with chronic lung disease, breathing management, conserving energy, pulmonary medications, inhaler devices, integrating exercise in your life, management of respiratory infections, management of aggravating environmental factors, management of stress and anxiety, nutrition, leisure and travel, getting a good night's sleep, enjoying intimacy, living in a smoke‐free environment, integrating long‐term oxygen into your life, keeping a healthy lifestyle

Outcomes

DEVICE Fitbit

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention

  • Follow‐up: 6 months

PRIMARY OUTCOME Physical activity: step count

SECONDARY OUTCOMES

  • HRQOL: CAT

  • Exercise capacity: 6MWD

Starting date

Prospectively registered; first posted September 2016; actual study start January 2017; estimated study completion August 2019

Contact information

Anne‐Marie Selzler [email protected]; Michael K Stickland [email protected] University of Alberta (Canada)

Notes

Collaborators: McGill University, University of Toronto, Université de Sherbrooke

NCT02924870

Trial name or title

Long‐term effect of a health education programme on daily physical activity in patients with moderate‐to‐very severe COPD (EA‐EPOC)

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 128

Blinding: none

Participants

Diagnosis of moderate‐to‐very severe COPD (GesEPOC criteria: FEV1 < 80% predicted, ≥ 3 months); smoking history (current or former) > 10 pack‐years; age > 35 years; hospital admission for AECOPD

Interventions

INTERVENTION health education

2 nursing health education sessions, 15 and 30 days after discharge

  • First session: basic information, care in COPD, management of conventional treatment, action plan

  • Second session: revision, new physical activity plan

NO INTERVENTION

Treatment and follow‐up according to conventional clinical practice including recommendations on healthy habits and lifestyle

Outcomes

PRIMARY OUTCOME Physical activity: “physical activity level”

SECONDARY OUTCOMES

  • Physical activity: step count, MVPA time, EE (> 3 METs), “profile of the daily physical activity"

  • HRQOL: CAT

Starting date

Prospective registration; estimated study completion March 2020

Contact information

Francisco Garcia‐Rio [email protected] Hospital Universitario La Paz, Madrid (Spain)

Notes

NCT02956213

Trial name or title

Assessing the effect of different efficiency indoor air filters on respiratory symptoms in former smokers

Methods

DESIGN 2 groups, cross‐over; COMPARISON intervention vs. sham; SAMPLE SIZE n = 52
Blinding: participant, investigator, outcomes assessor

Participants

Smoking history; does not currently smoke and no‐one currently smokes inside the home; history of AECOPD or development of respiratory symptoms with periods of high outdoor air pollution; age ≥ 40 years; access to Wi‐Fi, cell phone, tablet or personal computer

Interventions

INTERVENTION portable HEPA air filtering device with MERV17 air filter

SHAM portable air filtering device with basic carbon filter

Outcomes

ASSESSMENT TIME POINTS Baseline, 12 weeks, 3 months, 6 months

PRIMARY OUTCOME HRQOL: SGRQ

SECONDARY/OTHER OUTCOMES

  • Physical activity: step count

  • HRQOL: CAT

  • Exercise capacity: 6MWD

Starting date

Prospective registration; actual study completion June 2019

Contact information

Denitza Blagev, Intermountain Medical Center, Salt Lake City, Utah (USA)

Notes

N.B. will need to confirm specific diagnosis of COPD for inclusion, also will need pre‐cross‐over data

NCT02966561

Trial name or title

Pedometer‐based behavioural intervention for individuals with COPD to Stay Active After Rehabilitation (STAR)

Methods

DESIGN 2 groups COMPARISON intervention vs. placebo; SETTING PR clinic Bad Reichenhall (Germany); SAMPLE SIZE n = 502

Participants

Primary reason for referral to PR: diagnosis of COPD (classifications A – D; post‐bronchodilator FER < 0.7); age ≥ 18 years

Interventions

COMMON INTERVENTION

DURATION 3 weeks, extension 1 to 2 weeks if required (centre average 25 days)

SETTING inpatient PR

AEROBIC TRAINING 4 to 5 sessions, 45 minutes

STRENGTH TRAINING 3 sessions, 45 minutes

OTHER COMPONENTS 7 sessions whole‐body vibration muscle training

EDUCATION Structured COPD patient education

  • 6 hours patient education

  • 1 hour inhaler device training

  • Respiratory physiotherapy in groups (pursed lips breathing and other breathing and coughing techniques (2 sessions a week, 45 minutes)

  • Optional components: comprehensive smoking‐cessation programme (at least 8 sessions), mucolytic physiotherapy, inspiratory muscle training, neuromuscular electrostimulation, saline inhalation therapy, psychological interventions, social counselling (individual and groups), nutritional counselling, patient education concerning long‐term oxygen therapy, occupational therapy

Intervention components addressing the promotion of physical activity

INTERVENTION PAC: pedometer‐based behaviour change intervention

SETTING open groups, 6 to 12 participants

CONTACT 2 sessions, 45 minutes

  • First lesson: end week 2, pedometer and booklet containing diary and information

  • Second lesson: mid week 3

CONTENT

  • Instruction on how, where and when to perform the behaviour

  • Goal setting, self‐monitoring, feedback

PLACEBO “behavior placebo”

"Playful" physical activity and revisions of information on physical activity (knowledge of exercise recommendations, knowledge of possibilities of self‐regulation of endurance‐training exercise intensity) as in standard education

Booklet: looks identical to intervention group diary, contains a repetition of physical activity‐related information as for standard education

Outcomes

DEVICE Actigraph wGT3X‐BT

  • Wear instructions: 7 consecutive days

  • Data inclusion criteria: ≥ 4 valid days inclusive of a weekend day, ≥ 10 waking hours

    • non‐wear time is set at 60 minutes of zero counts (≤ 2 minutes, 0 to 100 count range)

Sedentary < 100 counts, MVPA > 1952 counts a minute

ASSESSMENT TIME POINTS

  • Baseline: 2 weeks pre PR

  • Start PR

  • End intervention

  • Follow up: 6 weeks, 6 months post‐PR

PRIMARY OUTCOME Physical activity: time sedentary (< 100 cpm), MVPA time (> 1952 cpm)

Starting date

"recruitment starts in June 2016 and is likely to be finished in September 2017"

Contact information

Wolfgang Geidl [email protected] Friedrich‐Alexander University, Erlangen (Germany)

Notes

FUNDING "This study is funded by the German Pension Insurance Association, Section Bavaria South (Deutsche Rentenversicherung Bayern Süd; Abteilung Rehabilitation und Sozialmedizin, Am Alten Viehmarkt 2, 84028 Landshut, Germany) (Reference number: 5.011‐6.031.115) (www.deutscherentenversicherung‐ bayernsued.de) which was not involved in the design of the study and collection, management, analysis, interpretation of data, in writing the manuscript, or the decision to submit the report for publication."

CONFLICT OF INTEREST "The authors declare that they have no competing interests."

NCT02999685

Trial name or title

Development and feasibility of a home PR program with health coaching

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 120

Participants

Diagnosis of COPD (GOLD stage II to IV; "as documented by PFT"); smoking history (current or former) ≥10 pack‐years; age ≥ 40 years; eligible for PR

Interventions

DURATION OF INTERVENTION 8 weeks

INTERVENTION home‐based PR with health coaching

SETTING home

INTERFACE

  • tablet computer:

    • exercise video

    • daily to‐do list and messages from the health coach (most pre‐programmed)

    • custom report: daily activity, physiological measures

    • submit questions

  • 1 coaching call a week, about 12 minutes

    • motivational interviewing

    • review daily steps, exercise timing, duration and frequency, physiological measures, well‐being questionnaire

    • set collaborative exercise goals for the following week

ACTIVITY

  • 6 full‐body, low‐intensity exercises, seated or standing

  • ≥ 12 minutes of focused, slow walking

MONITORING

  • pulse oximeter: monitoring not in real time, any significant physiologic abnormality (SpO2 < 85%, heart rate > 140 or < 40 beats a minute) will prompt call from coach

  • Vívofit 2 activity monitor: worn continuously, daily step counts and motivation

NO INTERVENTION

Outcomes

DEVICE Actigraph

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 8 weeks

OUTCOME MEASURES

  • Physical activity: (not defined)

  • HRQOL: CRQ

  • Adherence: telephone calls ≥ 6 of 8 weeks (completion)

Starting date

Estimated study completion June 2019

Contact information

Roberto Benzo [email protected] Mayo Clinic, Minnesota (USA)

Notes

FUNDING "Dr Kramer and Ms Seifert are affiliated with the Minnesota Health Solutions Corporation, Saint Paul, Minnesota. Dr Benzo, Ms Hoult, Ms Seifert, and Dr Kramer are supported by National Institutes of Health Grant SBIRHL 114162‐2 (to Ms Seifert [PI] and Dr Benzo [clinical trial PI]). Ms Seifert has disclosed a relationship with NovuHealth."

CONFLICT OF INTEREST "The other authors have disclosed no conflicts of interest"

NCT03073954

Trial name or title

The feasibility of working memory training in COPD patients and the efficacy on cognitive performance, self‐control and stress response

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 75

Blinding: participant, care provider, investigator, outcomes assessor

Participants

Diagnosis of COPD (GOLD); age ≥ 18 years; motivated as evaluated by the self‐determination questionnaire

Interventions

COMMON COMPONENTS

  • healthy lifestyle coaching focusing on healthy diet and daily physical activity

  • memory training: sessions 20 to 30 minutes, approximately 40 sessions

INTERVENTION working memory training and healthy lifestyle coaching

domain‐general cognitive working memory training programme

training increases with difficulty if participants answer 2 subsequent questions correctly

INTERVENTION sham working memory training and healthy lifestyle coaching

training that does not increase in difficulty

Outcomes

DEVICE (accelerometer

)PRIMARY OUTCOMES Adherence: training

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: CAT

  • Exercise capacity: 6MWD

Starting date

Prospective registration; estimated study completion July 2019

Contact information

Sarah Mount [email protected]; Martijn van Beers [email protected] Maastricht University Medical Center, Limburg (The Netherlands)

Notes

Collaborator: Eatwell

NCT03080662

Trial name or title

Impact of inspiratory muscle training on daily physical activity (INAF)

Methods

DESIGN 2 groups; COMPARISON intervention vs. sham; SAMPLE SIZE n = 20

Blinding: participant

Participants

Diagnosis of COPD; age 45 to 80 years; clinically stable ≥ 4 weeks; inspiratory muscle weakness (PImax < 70%); pulmonary hyperinflation (TLC > 120%)

Interventions

DURATION OF INTERVENTION 5 weeks

INTERVENTION inspiratory muscle training

OXYGEN DUAL Inspiratory valve with increase resistance

INTERVENTION sham inspiratory muscle training

Inspiratory valve without resistance

Outcomes

DEVICE (accelerometer)

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 5 weeks

PRIMARY OUTCOME

  • Physical activity: MVPA time

Starting date

Retrospective registration; estimated study completion March 2018

Contact information

Diego Agustin Rodriguez [email protected] Parc de Salut Mar, Hospital Del Mar (Spain)

Notes

NCT03084874

Trial name or title

Efficacy of a coaching programme to promote physical activity and reduce sedentary behaviour after a COPD exacerbation that require hospitalisation

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 66

Blinding: participant, investigator, outcomes assessor

Participants

Diagnosis of COPD (post‐bronchodilator FER < 0.7); smoking history > 10 pack‐years; age > 40 years; hospitalisation due to AECOPD

Interventions

DURATION OF INTERVENTION 12 weeks

INTERVENTION PAC

individualised physical activity and sedentary behaviour coaching

motivational interview; usual exercise habits, possible barriers and facilitators, self‐efficacy and motivation

progressive program with specific goals‐setting and self‐monitoring

NO INTERVENTION

Outcomes

DEVICE (accelerometer)

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks

PRIMARY OUTCOME

  • Physical activity: step count, time in sedentary behaviour (sitting or lying), breaks in sedentary behaviour (transitions to standing or walking), time in light (1.5 to 3 METs) and moderate physical activity (3 to 6 METs), active periods

SECONDARY OUTCOMES

  • HRQOL: SGRQ, CAT

  • Exercise capacity: 6MWD

Starting date

First posted March 2017; estimated study start March 2017; estimated study completion December 2018

Contact information

Maria A Ramon [email protected]; Esther Rodriguez [email protected] Hospital Universitari Vall d'Hebron Research Institute, Barcelona (Spain)

Notes

Collaborator: Spanish Society of Pneumology and Thoracic Surgery

NCT03114241

Trial name or title

Long‐term effects of a 3‐month pedometer‐based programme to enhance physical activity in patients with severe COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 74

Blinding: none

Participants

Diagnosis of COPD (GOLD severe; FEV1 < 50%); age ≥ 40 years

Interventions

DURATION OF INTERVENTION 12 months

INTERVENTION Pedometer and PAC

3 months coaching followed by 9 months (keep pedometer, encouraged to sustain an increased level of daily physical activity)

“encouraged to be more active”

Daily step count goal: 15% increase compared to baseline

Monthly telephone calls: encourage compliance, motivate

NO INTERVENTION

Outcomes

DEVICE SenseWear Pro (upper left arm); Wear instructions: 7 consecutive days

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 months

PRIMARY OUTCOME Physical activity: step count

SECONDARY OUTCOME HRQOL: CAT, SF36

Starting date

Prospectively registered; actual study start May 2017; estimated study completion August 2019

Contact information

Christian Clarenbach [email protected]; Noriane Sievi [email protected] University of Zurich (Switzerland)

Notes

NCT03127878

Trial name or title

Effects of upper‐limb endurance exercise training addition to a conventional high‐intensity exercise training programme on physical activity level and activities of daily living performance in patients with COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 64

Blinding: none

Participants

Diagnosis of COPD (GOLD); age 40 to 95 years; absence of AECOPD in the previous month (clinical stability); absence of severe or non‐stable cardiac disease; no exercise training programme within 1 year

Interventions

DURATION OF INTERVENTION 3 months

INTERVENTION High‐intensity endurance exercise of lower limb

strengthening exercise of upper and lower limb

INTERVENTION High‐intensity endurance exercise of upper and lower limb

strengthening exercise of upper and lower limb

Outcomes

PRIMARY OUTCOME Physical activity: sedentary time (< 1.5 METs), active time (> 3 METs)

SECONDARY OUTCOMES

  • HRQOL: CRQ, CAT

  • Exercise capacity: 6MWD, 6‐minute Pegboard and Ring Test, maximum exercise capacity (incremental test), endurance time (constant load test)

Starting date

Retrospective registration; first posted April 2017; actual study start January 2017; estimated study completion January 2020

Contact information

Fabio Pitta [email protected] Universidade Estadual de Londrina (Brazil)

Notes

Collaborator: National Council for Scientific and Technological Development (Brazil)

NCT03201198

Trial name or title

Active for life: COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. sham; SAMPLE SIZE n = 183

Blinding: outcomes assessor

Participants

Diagnosis of COPD; Age ≥ 50 years; no AECOPD or major illnesses requiring hospitalisation within 8 weeks; no history of other major lung diseases as primary pulmonary problem, history of a recent heart attack or recent onset of chest pains with activity or increasing episodes of chest pain; no other health or mobility problems that limit physical activity; sedentary (< 30 minutes of moderate activity, 3 days a week)

Interventions

DURATION OF INTERVENTION

  • 10 weeks, 18 sessions

  • Over 12 months following completion of structured interventions, 11 5‐minute phone coaching sessions, 2 booster sessions

INTERVENTION "Active Life" focus on increasing light physical activity; encouraged to increase total PA by ≥ 60 minutes a day

  • Structured walking: 20 minutes

  • Functional circuit training: intensity and speed; rating of perceived exertion (somewhat hard to hard)

  • Stretching major muscle groups

  • Behavioural component (self‐efficacy enhancing or confidence building) and health education

SHAM chair exercises, behavioural relaxation and health education

  • Chair exercises: seated, slow stretching (5 minutes), faster‐paced exercises (20 minutes), slower‐paced stretches (5 minutes), massage and imagery (5 to 10 minutes)

  • Guided imagery: promote relaxation

  • Health education: basic lung physiology, pathophysiology of COPD, medications, breathing techniques, healthy eating, physical activity, relaxation, travel considerations, energy conservation

Outcomes

DEVICE ActivPal and Actigraph; Wear instructions: 1 week

TIME POINTS

  • Baseline

  • End intervention: 10 weeks

  • Follow‐up: 3 months, 6 months, 12 months

PRIMARY OUTCOME Physical activity: time in physical activity, time sedentary (ActivPal), time in light‐intensity physical activity, MVPA time (Actigraph)

SECONDARY OUTCOMES

  • HRQOL: CRQ

  • Exercise capacity: 6MWD

Starting date

Prospectively registered; actual study start July 2017; estimated study completion February 2022

Contact information

She'Lon Tucker [email protected]; Ron Dechert [email protected], Janet Larson, School of Nursing, University of Michigan (USA)

Notes

NCT03275116

Trial name or title

The effect of twice‐daily aclidinium bromide/formoterol fumarate 340/12 mcg vs. once‐daily tiotropium 'respimat' 5 mcg on static and dynamic hyperinflation in patients with COPD during 24 hours

Methods

DESIGN 2 groups, cross‐over; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 49

Blinding: none

Participants

Diagnosis of COPD (moderate‐to‐very severe > 12 months before screening; post‐bronchodilator FEV1 < 80% predicted, FER < 0.7); smoking history (current or former) ≥ 10 pack‐years; age ≥ 40 years; modified MRC dyspnoea scale (score at least 2); entering PR at CIRO; severe static hyperinflation (RV > 150% predicted); co‐operative attitude and ability to use correctly the inhalers

Interventions

DURATION OF INTERVENTION 4 days

INTERVENTION LAMA/LABA (Aclidinium Bromide/Formoterol Fumarate 340/12 mcg) twice daily

INTERVENTION LAMA (Tiotropium 'Respimat' 5 mcg) once daily

Outcomes

DEVICE (accelerometer); Wear instructions: 4 days

SECONDARY OUTCOME Physical activity: “Nighttime physical activity” (inverse surrogate for sleep quality)

Starting date

Restrospective registration; first posted September 2017; actual study start July 2017, estimated study completion November 2018

Contact information

Lowie Vanfleteren lowievanfleteren@ciro‐horn.nl; Maud Koopman maudkoopman@ciro‐horn.nl CIRO, Horn (The Netherlands)

Notes

Sponsor: Maastricht University Medical Center

Collaborators: AstraZeneca

N.B. will need pre‐cross‐over data for inclusion, also clarification of physical activity

NCT03280355

Trial name or title

The effects of singing training for patients with COPD

Methods

DESIGN 2 groups, cluster‐randomised; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 220

Blinding: investigator, outcomes assessor

Participants

Diagnosis of COPD; age ≥ 18 years; modified MRC scale (score at least 2); recommended for PR; sufficient mobility to attend

Interventions

DURATION OF INTERVENTION 10 weeks

COMMON INTERVENTION PR

SETTING outpatient, group

CONTACT 2 sessions a week, 90 minutes (total 20 sessions)

CONTENT supervised warm‐ups, aerobic and strength training, breathing exercises

INTERVENTION singing training with PR

technical instruction in order to achieve better respiratory control and primary muscular strength

focus on techniques for efficient expiration

focus on musical content and interpretation as well as interaction, the social aspects and joy of singing together.

INTERVENTION PR

Outcomes

DEVICE (pedometer); Wear instructions: 1 week

PRIMARY OUTCOME Exercise capacity: 6MWD

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: SGRQ

  • Adherence

Starting date

Retrospective registration; actual study start August 2017; first posted September 2017; estimated study completion November 2018

Contact information

Mette Kaasgaard [email protected]; Uffe Bodtger [email protected] University of Aarhus (Denmark)

Notes

NCT03321279

Trial name or title

Social incentives to increase mobility among hospitalised patients: the MOVE IT randomised trial

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 227

Blinding: investigator, outcomes assessor

Participants

Pneumonia, diabetes, congestive heart failure, COPD; age ≥ 18 years; admitted to medicine or oncology floor in the hospital

Interventions

DURATION OF INTERVENTION 12 weeks post‐discharge

INTERVENTION pedometer with "social incentives"

daily step counts Week 2 to Week 13 after hospital discharge

weekly step goal: increases from baseline by 10% each week

social incentive‐based gamification based on points and levels

daily feedback for the step counts, weekly feedback for levels

support partner will receive weekly reports

INTERVENTION pedometer

daily step counts Week 2 to Week 13 after hospital discharge

Outcomes

DEVICE pedometer (Nokia Steel)

PRIMARY OUTCOME Physical activity: step count

Starting date

Prospectively registered; study start January 2018; estimated study completion October 2019

Contact information

Ryan Greysen, Mitesh Patel, University of Pennsylvania (USA)

Notes

N.B. will need data only for participants with COPD

NCT03359473

Trial name or title

A randomised, double‐blind (sponsor unblind), placebo‐controlled, multi‐centre phase IIa study to evaluate the safety and efficacy of 13 weeks of once daily oral dosing of the selective androgen receptor modulator (SARM) GSK2881078 in older men and post‐menopausal women with COPD and muscle weakness, participating in home exercise

Methods

DESIGN 2 groups; COMPARISON intervention vs. placebo; SAMPLE SIZE n = 100

Blinding: participant, investigator

Participants

Diagnosis of COPD (American Thoracic Society/European Respiratory Society criteria: post‐bronchodilator FEV1 30% to 65% predicted, FER < 0.7); smoking history (current or former) ≥ 10 pack‐years; age 50 to 75 years; BMI 18 to 32 kg/m2; able to read and write in the language used for the diary and able to operate electronic device; if participating in a structured exercise programme must be willing to convert their current exercise programme to the study programme

Interventions

INTERVENTION GSK2881078 Cohort 1 Males 2 mg capsules, once daily, oral administration

PLACEBO Cohort 1 men 2 capsules of placebo once daily, oral administration

INTERVENTION GSK2881078 Cohort 2 women 1 mg capsule, once daily, oral administration

PLACEBO Cohort 2 women 2 capsules of placebo once daily, oral administration

Outcomes

DEVICE (accelerometer); Wear instructions: 1 week

PRIMARY OUTCOME Adverse events and serious adverse events

SECONDARY OUTCOMES

  • Physical activity: (not defined)

  • HRQOL: CAT, SGRQ

  • Exercise capacity: ISWT, ESWT

Starting date

Prospectively registered; study start February 2018; estimated study completion November 2019

Contact information

Notes

Sponsor: GlaxoSmithKline

Collaborator: Parexel (USA, Germany, UK)

NCT03513068

Trial name or title

Portable oxygen concentrator improvements to physical activity, oxygen usage, and quality of life in COPD patients using LTOT (POC‐STEP)

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 190

Blinding: none

Participants

Diagnosis of COPD; age ≥ 40 years; qualifies for continuous LTOT, prescribed oxygen at ≤ 5 litres a minute; has not used a portable oxygen concentrator prior to enrolling in this study; able to tolerate pulsed oxygen therapy

Interventions

INTERVENTION portable oxygen concentrator with LTOT

INTERVENTION LTOT

Outcomes

DEVICE "Actigraphy"

PRIMARY OUTCOME Physical activity: (not defined)

SECONDARY OUTCOME HRQOL: SGRQ

Starting date

Prospectively registered; study start July 2018; estimated study completion February 2021

Contact information

Cindy Wen [email protected] ResMed (USA)

Notes

Collaborator: Inogen, Inc (USA)

NCT03584269

Trial name or title

Non‐invasive ventilation and nocturnal alveolar hypoventilation in patients with COPD treated by long‐term oxygen therapy at home

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 38

Blinding: none

Participants

Diagnosis of COPD; age 18 to 85 years; LTOT

Interventions

INTERVENTION non‐invasive ventilation (respiratory assistance by a facial mask without intubation or tracheotomy) with LTOT

INTERVENTION LTOT

Outcomes

SECONDARY OUTCOMES

  • Physical activity: step count, time in supine and sitting positions, EE (one week, measured at home)

  • HRQOL: SGRQ

Starting date

Actual study start June 2018; first posted July 2018; estimated study completion April 2020

Contact information

Jean‐Louis Pépin JPepin@chu‐grenoble.fr Marjorie Dole mdole2@chu‐grenoble.fr University Hospital, Grenoble (France)

Notes

Collaborators: AGIR à Dom, ResMed

NCT03584295

Trial name or title

A multicentre, randomised‐controlled trial of extracorporeal CO2 removal (ECCO2R) to facilitate early extubation compared to invasive mechanical ventilation in patients with severe AECOPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 202

Blinding: none

Participants

Known history of COPD; age 18 to 75 years; AECOPD requiring invasive mechanical ventilation; acute and potentially reversible cause of acute respiratory failure

Interventions

INTERVENTION Extracorporeal carbon dioxide removal

Invasive mechanical ventilation treated with vv‐ECCO2R (Extracorporeal carbon dioxide removal) to facilitate early extubation

Standard configuration with either double lumen cannula (20 to 22 Fr) or 2 small single vessel cannulas (15 to 19 Fr), allowing a blood flow rate between 1 and 2 litres a minute

INTERVENTION conventional care

Invasive mechanical ventilation; attempt to extubate and switch to non‐invasive ventilation

If extubation fails, tracheostomy can be performed according to treating physician

Outcomes

DEVICE Actigraph; Wear instructions: up to 60 days

SECONDARY OUTCOMES

  • Physical activity: “activity per day”

  • HRQOL: EQ5D

Starting date

Prospectively registered; estimated study start January 2019; estimated study completion July 2023

Contact information

Christian Karagiannidis christian.karagiannidis@uni‐wh.de Anne Hage‐Hülsmann Anne.hage‐huelsmann@uni‐wh.de University of Witten/Herdecke (Germany)

Notes

NCT03620630

Trial name or title

Evidence generation for the clinical efficacy and cost effectiveness of myCOPD in patients with mild and moderate newly‐diagnosed COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 60

Blinding: outcomes assessor

Participants

Diagnosis of COPD (mild or moderate; FEV1 > 50% predicted) or diagnosed within 12 months (FER < 0.7); smoking history (current or former); age 40 to 80 years; currently taking inhaled medications; access to the internet at home, use of mobile technology and the ability to operate a web platform in English

Interventions

INTERVENTION "myCOPD" web‐based application designed to support people in long‐term management of COPD

NO INTERVENTION

Outcomes

DEVICE FITBIT (pedometer)

  • Wear instructions: 1 week

  • 12 patients from each group

PRIMARY OUTCOME HRQOL: CAT

SECONDARY OUTCOMES

  • Physical activity: step count (n = 12 from each group)

  • HRQOL: EQ5D

  • Adverse and serious adverse events

Starting date

Prospectively registered; actual study start November 2018; estimated study completion February 2019

Contact information

Mal North [email protected] Chloe Barker [email protected] my mhealth Limited, Bournemouth (UK)

Notes

Collaborators: Innovate UK, Imperial College London, Hull and East Yorkshire Hospitals NHS Trust Hampshire Hospitals NHS Foundation Trust, Central London Community Healthcare NHS Trust

NCT03654092

Trial name or title

Effects of a long‐term home‐based exercise training programme using minimal equipment vs. usual care in COPD patients: a study protocol for 2 multicentre randomised controlled trials (HOMEX‐1 and HOMEX‐2 trials)

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention SETTING Canton of Zurich (Switzerland); SAMPLE SIZE n = 120 (based on CRQ dyspnoea domain)

Blinding: none

Participants

Diagnosis of COPD (GOLD stages II to IV; post‐bronchodilation FEV1 < 80% predicted; FER < 0.7); age ≥ 40 years; no PR within 2 years

Interventions

DURATION OF INTERVENTION 12 months

INTERVENTION home‐based exercise

SETTING home

CONTACT

  • 3 home visits by “personal coach”

    • Baseline visit, 2 hours

      • explore ability to perform exercises, exercise card instruction

      • concrete training setting, i.e. precise location, training schedule

      • interactive training book: daily, goals, workouts, define concrete motivational resource

    • Visit at 3 weeks: review training volume and intensity, training book, goals

    • Visit at 8 to 9 weeks: review training volume and intensity, goals

  • CALLS

    • 2 calls in first 10 days, 1 call every 2 weeks for the first 6 months, every 5 weeks after, except for situations when training elements have changed

    • guidance manual to motivate the participants, discuss training progress and concrete benefits and barriers, adapt goals and the training programme (exercise intensity, duration)

    • call coach if could not perform the exercises for > 3 consecutive days

    • For each contact; guidance documents with algorithms how to proceed in specific situations

TRAINING 6 days a week, 15 to 20 minutes, individualised and progressive strength‐training, 3 different levels

CONTENT

  • Motivational interview techniques

  • Relative, friend or close person is involved as a “sparring” partner to support exercise training on a regular basis

NO INTERVENTION

Outcomes

DEVICE ActiGraph, Wear instructions: 1 week

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 months

PRIMARY OUTCOME HRQOL: CRQ dyspnoea domain

SECONDARY OUTCOMES

  • HRQOL: CRQ other domains, EQ5D, CAT

  • Exercise capacity: 6MWD

  • Adherence

  • Adverse events: SAEs

Starting date

Prospectively registered; study start October 2018; estimated primary completion October 2020

Contact information

Anja Frei [email protected] University of Zurich (Switzerland)

Notes

FUNDING "HOMEX‐2 is supported by LUNGE ZÜRICH, Switzerland.The funding bodies had/have no role in the design of the study, data collection, analysis and interpretation of data and in writing the manuscript."

CONFLICT OF INTEREST "The authors declare that they have no competing or financial interests."

N.B. physical activity not assessed in HOMEX‐1

NCT03655028

Trial name or title

Increasing physical activity in COPD through rhythmically‐enhanced music

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 170

Blinding: investigator, outcomes assessor

Participants

Diagnosis of COPD (FEV1 < 70% predicted, FER < 0.7); age ≥ 40 years; mean SpO2 88% at peak exercise (with or without oxygen supplementation); ability to hear music

Interventions

DURATION OF INTERVENTION 12 weeks

INTERVENTION home‐based exercise programme with rhythmically auditory stimulation‐enhanced music

INTERVENTION home‐based exercise programme without music

Outcomes

DEVICE Actigraph (hip); Wear instructions: 1 week

PRIMARY OUTCOME Exercise capacity: 6MWD

SECONDARY OUTCOMES

  • Physical activity: “volume”

  • Exercise capacity: endurance time (constant‐load treadmill test)

  • Adherence: “to the 12‐week program”, “adherence to follow‐up”

Starting date

Prospective recruitment; study start October 2018; estimated study completion September 2022

Contact information

Susan A O'Connell Schnell [email protected] Franco Laghi [email protected] Edward Hines Jr. VA Hospital, Illinois (USA)

Notes

Sponsor: VA Office of Research and Development

NCT03660644

Trial name or title

Physical activity following PR in patients with COPD

Methods

DESIGN 2 groups, cluster; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 60

Blinding: outcomes assessor, "Physiotherapists will be aware of the allocation of the programmes (not possible to blind) as they will be involved with delivering information/training of intervention components. A researcher blinded to group allocation will perform quantitative analysis."

Participants

Diagnosis of COPD; age 30 to 100 years; enrolled in PR within Lincolnshire Community Health Services; for telephone interviews: access to a telephone

Interventions

DURATION OF INTERVENTION 12 months following PR

INTERVENTION PAC

  • pedometer: report step count daily in paper diary

  • group chat on WhatsApp

NO INTERVENTION

Outcomes

ASSESSMENT TIME POINTS

  • Baseline: during PR

  • Mid‐intervention: 12 weeks post‐PR

  • End intervention: 52 weeks post‐PR

PRIMARY OUTCOME MEASURE Adherence : “acceptability” number of participants who comply with intervention

SECONDARY OUTCOMES

  • Physical activity: step count, sedentary time, time spent in different activity intensities, sleep, vector magnitude units

  • HRQOL: CRQ

  • Exercise capacity: ISWT

Starting date

Retrospectively registered; actual study start June 2018; first posted September 2018; estimated study completion October 2019

Contact information

Hayley Robinson [email protected] Arwel Jones [email protected] University of Lincoln (UK)

Notes

Collaborators: NHS PR clinics across Lincolnshire, United Kingdom, British Lung Foundation, University College, University of Oxford

NCT03746873

Trial name or title

A web‐based self‐management intervention to increase level of physical activity and decrease use of health care for people with COPD in primary care: a protocol for a randomised controlled clinical trial

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 144

Blinding: none

Participants

Diagnosis of COPD (ICD‐10:J44:9); age ≥ 40 years; visit included primary care units due to COPD; have a smartphone, tablet or computer with access to internet

Interventions

INTERVENTION PAC (COPD Web) with pedometer

written information about the importance of physical activity

website, self‐managed

  • email reminder to register the number of steps walked during that week

  • Weeks 1 to 12: weekly; Weeks 12 to 24: fortnightly; Weeks 24 to 52: every 4th week

INTERVENTION pedometer

written information about the importance of physical activity

Outcomes

DEVICE DynaPort MiniMod; Wear instructions: 1 week

ASSESSMENT TIME POINTS

  • Baseline

  • 3 months

  • 12 months

PRIMARY OUTCOME Physical activity: (not defined)

SECONDARY OUTCOME HRQOL: CAT, CRQ

Starting date

Study start November 2018; estimated study completion March 2020

Contact information

Tobias Stenlund [email protected]; Karin Wadell [email protected] Umeå University (Sweden)

Notes

NCT03749655

Trial name or title

A feasibility study assessing the inclusion of physical activity promotion to standard care PR and cognitive behavioural therapy in patients with COPD who are anxious and depressed

Methods

DESIGN 2 groups; COMPARISON; intervention vs. intervention; SAMPLE SIZE n = 40

Blinding: single, principal investigator will be blinded from the randomisation as this member will conduct cognitive behavioural therapy

Participants

Diagnosis of COPD (obstructive spirometry); age ≥ 40 years; clinically stable; optimised medical therapy; HADS score ≥ 8

Interventions

DURATION OF INTERVENTION 8 weeks

INTERVENTION PAC with PR and cognitive behavioural therapy

SETTING consultation sessions

CONTACT 2 sessions a week (total 16 sessions)

CONTENT

  • step‐counter with a digital display

  • interview discussing motivational issues, favourite daily activities and strategies to become more physically active

    • tailored physical activity coaching plan including an individualised daily step goal, revised twice weekly

    • aim to increase physical activity by 10% each week

INTERVENTION PR and cognitive behavioural therapy

Outcomes

DEVICE (triaxial accelerometer); Wear instructions: 1 week

ASSESSMENT TIME POINTS

  • Pre‐PR

  • End intervention

PRIMARY OUTCOME Adherence: PAC

    • use the step counter during iPAC and PR

    • compliance defined as at least 4 days a week with valid step count data (> 70 steps a day)

    • should have at least 6 weeks (75%) compliance

SECONDARY OUTCOMES

  • Physical activity: step count

  • HRQOL: SGRQ, CCQ

  • Exercise capacity: 6MWD

Starting date

Prospectively registered; study start November 2018; estimated study completion May 2020

Contact information

Matthew Armstrong [email protected] Northumbria University; Karen Heslop‐Marshell [email protected] Newcastle Upon Tyne, Tyne And Wear (UK)

Notes

NCT03750292

Trial name or title

Residential cleaning of indoor air to reduce acute exacerbations of COPD (CARE): a pilot randomised cross‐over trial

Methods

DESIGN 2 groups, cross‐over; COMPARISON intervention vs. placebo; SAMPLE SIZE n = 20

Blinding: participant, investigator, outcomes assessor

Participants

Diagnosis of COPD (severe; FEV1 < 50% predicted); age ≥ 18 years; live in Monroe County; referred for PR; AECOPD within 1 year; standard‐sized windows in their bedroom and living room amenable to device installation; expect to sleep each night of the study (2 months of period 1, 2 months of period 2) in either their bedroom or living room ≥ 6 hours a night, no other air filtering devices

Interventions

INTERVENTION HEPAirX air filter

medical re‐circulating air cleaner 99.97% efficient filter for particles 0.3 µm in size

PLACEBO provides only recirculation (without filtration or ventilation using outdoor air) and temperature control of room air

Outcomes

PRIMARY OUTCOMES

  • Physical activity: step count

  • HRQOL: SGRQ

Starting date

Retrospective registration; actual study start March 2019; first posted November 2018; estimated study completion October 2020

Contact information

Daniel Croft [email protected] University of Rochester Medical Center, New York (USA)

Notes

N.B. will need pre‐cross‐over data for inclusion

NCT03793192

Trial name or title

Promoting activity after COPD exacerbations: Aim 2 (PACE2)

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 64

Selection bias: "Allocation sequence will be concealed"; Blinding: outcomes assessor

Participants

Diagnosis of COPD (physician‐diagnosed); age ≥ 18 years; hospitalised as an inpatient, 23‐hour observation, or clinical decision unit; admitting respiratory conditions sensitive to the Centers for Medicare and Medicaid Services Hospital Readmission Reduction Program as listed (AECOPD, asthma/COPD overlap, decompensated heart failure, pneumonia, chronic airway disease)

Interventions

DURATION OF INTERVENTION 12 weeks

INTERVENTION PAC (PACE2) with pedometer

  • Written educational materials

  • Telephone‐based coaching: integrate physical activity in daily life activities and address barriers to attending PR

INTERVENTION pedometer

Outcomes

PRIMARY OUTCOME Physical activity: step count (averaged over 1 week, over time using repeated measures over 12 weeks)

Starting date

First posted January 2019; estimated study completion May 2022

Contact information

Valentin Prieto‐Centurion, University of Illinois, Chicago (USA)

Notes

NCT03794921

Trial name or title

Leveraging technology to address access and adherence to conventional hospital‐based PR in veterans with COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 120

Blinding: outcomes assessor, "study staff communicating randomization assignments to subjects will be different from study staff conducting follow‐up outcome assessments"

Participants

Diagnosis of COPD (FER < 0.70 or chest CT evidence of emphysema or prior documentation of FER < 0.70 and clinical evidence of COPD defined as 10 pack‐year cigarette smoking history, dyspnoea or on bronchodilators); age ≥ 40 years; declined participation in conventional PR; medical clearance to participate in exercise; access to computer with Internet connection, a USB port or Bluetooth capability, and Windows XP/Vista/7/8/10 or higher, or Mac OSX 10.5 or higher operating system, or willing to come to VA Medical Center to use study computers; pedometer and accelerometer with > 90% accuracy compared to manual counts on short clinic walk

Interventions

DURATION OF INTERVENTION 12 weeks

INTERVENTION PAC (Every Step Counts)

  • Pedometer: every day, except while asleep or showering/bathing

  • Website

    • Upload step count as often as they wish, at least weekly

    • Weekly algorithm revision of step‐count goal

  • Walking ≥ 30 minutes on most days of the week, Borg scale dyspnoea (moderate intensity, rating 4 to 5)

NO INTERVENTION

  • randomisation phone call, verbal instructions to slowly and steadily increase one's walking and exercise each week

  • exercise ≥ 30 minutes on most days of the week, Borg scale dyspnoea (moderate intensity, rating 4 to 5); can be walking in the community or using exercise equipment at a local gym

  • adapted written materials reinforce the verbal instructions, book with information about aerobic and strength training exercises

Outcomes

DEVICE (pedometer)

PRIMARY OUTCOME Physical activity: step count

SECONDARY OUTCOMES

  • HRQOL: SGRQ, EQ5D

  • Exercise capacity: 6MWD

  • Adherence: self‐report exercise using daily logs

Starting date

Prospectively registered; estimated start September 2019; estimated completion April 2024

Contact information

Marilyn Moy [email protected]; Eric Garshick [email protected] VA Boston Healthcare System (USA)

Notes

SPONSOR VA Office of Research and Development

NCT03807310

Trial name or title

The effect of targeted nutrient supplementation on physical activity and HRQOL in advanced COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 166

Blinding: participant, investigator, outcomes assessor

Participants

Diagnosis of COPD (GOLD); age ≥ 18 years; medically stable; history of ≥ 2 moderate AECOPDs, ≥ 1 severe AECOPD (GOLD stage C and D) or FEV1 < 50% predicted and ≥ 1 moderate or severe AECOPD within 12 months

Interventions

DURATION OF INTERVENTION 12 months

COMMON COMPONENT Counselling

CONTACT once a month

CONTENT healthy lifestyle (physical activity, smoking cessation, weight management) by motivational interviewing

INTERVENTION Targeted nutrient supplement (once daily) with counselling

INTERVENTION Placebo supplement (once daily) with counselling

Outcomes

DEVICE activPAL; Wear instructions: 1 week

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: three months

  • End intervention: 12 to 14 months

PRIMARY OUTCOMES

  • Physical activity: step count

  • HRQOL: EQ5D

SECONDARY/OTHER OUTCOMES

  • HRQOL: CAT, CCQ

  • Exercise capacity: 6MWD

Starting date

First posted January 2019; estimated study completion May 2023

Contact information

Rosanne Beijers [email protected]; Harry Gosker [email protected] Maastricht University Medical Center (The Netherlands)

Notes

Collaborator: Nutricia Research

NCT03810755

Trial name or title

EfiKroniK research programme: effectiveness of physical exercise for people with chronic pathologies. Hybrid, clinical and implementation randomised trial

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 370

Blinding: care provider, outcomes assessor

Participants

Diagnosis of COPD; Age 18 to 75 years; BODE index (score 3 to 7); clinical stability (absence of exacerbation, antibiotic treatment, systemic corticosteroids or hospitalisation within 30 days); life expectancy > 2 years; colon, breast or lung solid cancers stage IV non‐small cell with standard first‐line chemotherapy treatment; malignant haemopathy with autologous transplant or lymphomas not localised, in treatment with immunotherapy; schizophrenia; adequate renal, hepatic and haematological function

Interventions

DURATION OF INTERVENTION 12 weeks

INTERVENTION "personalised exercise program"

SETTING supervised

nursing in primary and autonomous care afterwards, with support from community resources

NO INTERVENTION

Outcomes

DEVICE Actigraph xGT3X‐BT (right iliac crest); Wear instructions: 1 week

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks

  • Follow‐up: 6 months, 12 months

PRIMARY OUTCOMES

  • Physical activity: (not defined)

  • HRQOL: EORTC QLQ‐ HDC30, CAT, RQ, SF36

  • Exercise capacity: 6MWD

Starting date

Retrospective registration; actual start January 2018; first posted January 2019; estimated study completion December 2020

Contact information

Nere Mendizabal [email protected] Primary Care Research Unit of Bizkaia, Bilbao (Spain)

Notes

SPONSOR Basque Health Service (Spain)

N.B. will need COPD‐only data for inclusion in this review

NCT03817294

Trial name or title

Personalised exercise training in COPD ‐ exploring the interaction between exercise physiology, exercise perception and training progression

Methods

DESIGN "pilot/feasibility study aiming to characterise exercise limitation at baseline and then conducting an abridged RCT with four training arms"; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 60

Participants

Diagnosis of COPD (FEV1 < 80% predicted, FER < 0.7); age ≥ 40 years; MRC dyspnoea scale (score ≥ 3); stable dose of current regular medication within 4 weeks; clinically‐acceptable ECG at enrolment

Interventions

INTERVENTION Eccentric cycling

INTERVENTION Concentric cycling

INTERVENTION Single‐leg cycling

INTERVENTION Lower‐limb resistance training

Outcomes

DEVICE “seven‐day activity monitor”

PRIMARY OUTCOME Adherence: training attendance

SECONDARY OUTCOMES

  • Physical activity: LIPA time, MVPA time

  • HRQOL: SGRQ

  • Exercise capacity: peak V̇O2, endurance time (constant work rate cycling test)

Starting date

Retrospectively registered; first posted January 2019; actual start October 2018; estimated study completion August 2019

Contact information

Tom Ward [email protected] Loughborough University (UK)

Notes

NCT03869112

Trial name or title

The effectiveness of a physical activity intervention versus PR on cardiovascular risk markers for individuals with COPD: a feasibility study

Methods

DESIGN 3 groups; COMPARISONS intervention vs. intervention, intervention vs. no intervention; SAMPLE SIZE n = 60

Participants

Diagnosis of COPD; age 40 to 85 years

Interventions

DURATION OF INTERVENTION 6 weeks

INTERVENTION PAC

SETTING home‐based, unsupervised

CONTENT FitBit device: step targets (increase by 500 steps a week)

INTERVENTION PR

SETTING outpatient, supervised, group

CONTENT exercise and education

NO INTERVENTION

Outcomes

DEVICE Actigraph

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 8 weeks

PRIMARY OUTCOMES

  • Physical activity: step count

  • HRQOL: CRQ, CAT

  • Exercise capacity: ISWT, ESWT

Starting date

First posted March 2019; estimated study completion February 2020

Contact information

Tareq Alotaibi [email protected]; David Stensel [email protected]; Sally Singh sally.singh@uhl‐tr.nhs.uk University Hospitals of Leicester NHS Trust (UK)

Notes

NCT03899558

Trial name or title

The role of humidified nasal high‐flow to reduce 30‐day hospital re‐admissions following severe exacerbations of COPD: a mixed‐methods feasibility study

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 80

Blinding: none

Participants

Emergency hospital admission with a primary diagnosis of AECOPD; smoking history ≥ 10 pack‐years; age 40 to 80 years; BMI ≤ 35kg/m2; to be discharged to home environment deemed safe to perform home assessments; live in the catchment area

Interventions

DURATION OF INTERVENTION hospital length of stay

INTERVENTION Humidified nasal high‐flow device

warmed, humidified air at flow rates of up to 60 litres a minute through a nasal cannula interface (intended delivery 30 litres a minute at 37 ºC if tolerated)

NO INTERVENTION

Outcomes

DEVICE (triaxial accelerometer) (wrist)

ASSESSMENT TIME POINTS Follow‐up: 30 days following discharge

SECONDARY OUTCOMES

  • Physical activity: counts a minute

  • HRQOL: CAT, CCQ

  • Adherence: symptom diary completion, physical activity monitor, spirometry, device usage

Starting date

First posted April 2019; estimated study completion August 2021

Contact information

Nicholas Hart [email protected]; Rebecca D'Cruz [email protected] Guy's and St Thomas' NHS Foundation Trust (UK)

Notes

NL3827

Trial name or title

PRACTISS COPD; PR of COPD: a trial of sustained internet based self‐management support

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 100

Blinding: single

Participants

Pulmonologist‐diagnosed COPD (FER < 0.7); COPD most important limiting factor; PR completion

Interventions

DURATION OF INTERVENTION 1 year following PR

INTERVENTION self‐management by internet "PatientCoach‐platform"

Tools are available to guide discussion; participant determines goal, identifies barriers and plans for overcoming the barriers

NO INTERVENTION

Outcomes

ASSESSMENT TIME POINTS

  • Every 3 months: digital questionnaires

  • "Throughout the follow‐up year patients in the intervention group will be encouraged to wear an activity monitor daily to gain insight in their physical activity pattern"

PRIMARY OUTCOME HRQOL: CRQ

SECONDARY OUTCOMES

  • Physical activity: "actual activity"

  • Exercise capacity: "shuttle walk test"

Starting date

Study dates February 2013 to February 2015

Contact information

Jacob Sont [email protected] Leids Universitair Medisch Centrum (The Netherlands)

Notes

FUNDING Netherlands Asthma Foundation

Email sent to enquire regarding objective assessment of physical activity and availability of results

NL5277

Trial name or title

Efficacy of a physical activity coaching system for patients with COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 90

Blinding: none

Participants

Diagnosis of COPD (GOLD); age > 45 years; referred for PR; clinical stability within 4 weeks (pulmonary infections or AECOPD); absence of recent myocardial Infarction (within 3 months), unstable angina, other significant cardiac problems, resting systolic blood pressure > 180 mmHg, resting diastolic blood pressure > 100 mmHg or tachycardia; absence of significant orthopaedic, neurological, cognitive and/or psychiatric impairment restricting mobility; internet access at home

Interventions

DURATION OF INTERVENTION 8 weeks following inpatient PR

INTERVENTION PAC

Philips physical activity coaching system

NO INTERVENTION

wears activity monitor

no coaching or insight into physical activity

Outcomes

ASSESSMENT TIME POINTS

  • Pre‐PR

  • End PR/start intervention: 8 to 16 weeks

  • End intervention: after 8 weeks at home

PRIMARY OUTCOME Physical activity: (not defined)

Starting date

Study dates April 2015 to March 2018

Contact information

Marian Dekker [email protected] Philips Research

Notes

FUNDING Philips Research and CIRO+ expertise Center (The Netherlands)

Email sent 23 August 2019 to ask about possible relationship with Priori 2017 or Saini 2017

RBR‐3zmh3r

Trial name or title

Effects of the inclusion of a functional circuit to aerobic and resistance training on functionality, physical activity in daily life and immuno‐metabolic response of patients with COPD: a randomised clinical trial with follow‐up

Methods

DESIGN 3 groups; COMPARISONS intervention vs. intervention, intervention vs. no intervention; SAMPLE SIZE n = 75

Blinding: none

Participants

Diagnosis of COPD (GOLD); age 18 to 100 years; clinically stable (no AECOPD or changes in medications within 30 days); non‐smokers; no home oxygen therapy; no pathological conditions that prevent physical activity, severe or unstable heart disease, other pathological condition that may influence the systemic inflammatory process; not participating in another systematic exercise programme

Interventions

COMMON COMPONENT Aerobic training (treadmill)

  • Intensity: 80% 6MWT speed

  • Progression: Borg scale dyspnea (rating 4 to 6; intensity maintained, rating < 4; 5% increase)

INTERVENTION "GTF"

  • Aerobic training

  • Functional circuit training: three resistance training exercises, 12 stations

INTERVENTION "GTC" Aerobic training only

NO INTERVENTION including respiratory physiotherapy techniques

Outcomes

OUTCOME MEASURES

  • Physical activity: (not defined)HRQOL: (not defined)

Starting date

Prospectively registered; planned last enrolment July 2019

Contact information

Ercy Mara Cipulo Ramos [email protected]; Fabiano Lima [email protected] Universidade Estadual Julio de Mesquita Filho, Presidente Prudente, São Paulo (Brazil)

Notes

FUNDING "Fundação de Amparo a Pesquisa do Estado de São Paulo (Brazil)"

N.B. need to confirm objective assessment of physical activity for inclusion

UMIN000027190

Trial name or title

The effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance‐naïve Japanese patients with COPD

Methods

DESIGN 2 groups; COMPARISON intervention vs. intervention; SAMPLE SIZE n = 80

Blinding: none

Participants

Diagnosis of COPD (FEV1 < 80% predicted, FER < 0.7); smoking history (current or former); age 40 to 85 years; maintenance treatment‐naïve

Interventions

DURATION OF INTERVENTION 12 weeks

INTERVENTION LAMA/LABA (tiotropium and olodaterol)

INTERVENTION LAMA (tiotropium)

Outcomes

DEVICE (triaxial accelerometer)

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 12 weeks

SECONDARY OUTCOMES

  • Physical activity: (not defined)

  • HRQOL: CAT

  • Exercise capacity: 6MWD

Starting date

Disclosure of study information April 2017; last follow‐up May 2019; recruitment status: no longer recruiting

Contact information

Koichiro Takahashi [email protected]‐u.ac.jp Division of Respiratory Medicine, Saga University (Japan)

Notes

FUNDING Nippon Boehringer Ingelheim Co, Ltd

UMIN000031173

Trial name or title

Combined effect of progressive resistance training and physical activity counselling in patients with COPD: a randomised controlled cross‐over study

Methods

DESIGN 2 groups, cross‐over; COMPARISON intervention vs. no intervention; SAMPLE SIZE n = 15

Blinding: none

Participants

Diagnosis of COPD (GOLD); age 18 to 90 years

Interventions

DURATION OF INTERVENTION 8 weeks

INTERVENTION exercise training and PAC

CONTACT 1 session a week

CONTENT

  • 4 resistance‐training sessions: intensity: modified Borg scale (rating 4 to 7); progression: each week, set or number of repetitions, rest time

  • Counselling: pedometer feedback

NO INTERVENTION

Outcomes

DEVICE (pedometer)

ASSESSMENT TIME POINTS

  • Baseline

  • End intervention: 8 weeks

PRIMARY OUTCOME Physical activity: step count

SECONDARY OUTCOMES

  • HRQOL: CAT, SGRQ, SF36

  • Exercise capacity: 6MWD

Starting date

Disclosure of study information February 2018; Recruitment status: completed

Contact information

Chiharu Fujisawa [email protected] Shinko Hospital Rehabilitation Center (Japan)

Notes

Funding: Japan Science and Technoligy Agency

N.B. will need pre‐cross‐over data for inclusion

UMIN000033093

Trial name or title

The effect of comprehensive respiratory rehabilitation using cloud system on exacerbation of patients with COPD at home

Methods

DESIGN 2 groups; COMPARISON intervention vs..no intervention; SAMPLE SIZE n = 50

Blinding: none

Participants

Diagnosis of COPD (Guidelines for Diagnosis and Treatment of COPD 4th Edition, Japan Respiratory Society); age ≥ 65 years; stable; attending Shinshu University Medical School Hospital for the purpose of diagnosis and treatment of COPD

Interventions

INTERVENTION "comprehensive respiratory rehabilitation"

SETTING home

CONTACT multi‐occupational co‐operation tool

CONTENT Exercise; physical activity instruction in daily life; education

NO INTERVENTION

Outcomes

SECONDARY OUTCOME Physical activity

Starting date

Disclosure of the study information July 2018

Contact information

Shohei Kawachi drodman@shinshu‐u.ac.jp Shinshu University Hospital Rehabilitation Department (Japan)

Notes

N.B. need to confirm objective assessment of physical activity for inclusion

Zanaboni 2016

Trial name or title

Long‐term integrated telerehabilitation of COPD patients: a multicentre randomised controlled trial (iTrain)

Methods

DESIGN 3 groups; COMPARISONS intervention vs. intervention, intervention vs. no intervention; SETTING Australia, Denmark, Norway; SAMPLE SIZE n = 120

Participants

Diagnosis of COPD (FEV1 < 80% predicted, FER < 0.7); age 40 to 80 years; ≥ 1 COPD‐related emergency department presentation or hospitalisation within 12 months

Interventions

STUDY DURATION two years

"Any participant in the trial can undertake a traditional PR program at any time during the study period if it is considered clinically indicated by their usual treating team"

INTERVENTION Telerehabilitation

SETTING home

CONTACT

  • Website

    • individual training programme and goals

    • daily diary, training diary

  • Videoconferencing sessions

    • set specific goals

    • self‐management education and training

    • ≥ 1 session a week in the first 8 weeks, then ≥ 1 session a month

AEROBIC TRAINING treadmill, ≥ 30 minutes

  • Continuous training: 3 to 5 sessions a week, Borg scale (moderate intensity, rating up to 4)

  • Interval training: 3 sessions a week, up to 4 interval bouts (1 to 4 minutes), Borg scale (high‐intensity, rating up to 6)

STRENGTH TRAINING 2 to 3 sessions a week

INTERVENTION Unsupervised exercise training

SETTING unsupervised, home

TRAINING treadmill

Individualised, prescribed as for telerehabilitation arm, no review or progression

Record sessions in paper‐based diary

NO INTERVENTION

Outcomes

DEVICE SenseWear Armband (software version 7.0) (left upper arm)

  • Wear instructions: 1 week (remove for bathing or water‐based activities)

  • Data inclusion criteria: ≥ 4 valid days inclusive of at least 1 weekend day, excluding first and last days, ≥ 10 hours wear time

ASSESSMENT TIME POINTS

  • Baseline

  • Mid‐intervention: 6 months, 12 months

  • End intervention: 2 years

SECONDARY OUTCOMES

  • Physical activity: step count, sedentary time (≤ 1.5 METs), MVPA time (≥ 3 METs)

  • HRQOL: CAT, EQ5D

  • Exercise capacity: 6MWD

  • Adverse events: "Adverse events, including deaths, treadmill injuries and other unspecified reasons, will be recorded in the WebCRF program"

Starting date

Prospectively registered; study start October 2014; final data collection for primary outcome measure December 2018

Contact information

Paolo Zanaboni [email protected] University Hospital of North Norway, Tromsø (Norway)

Notes

FUNDING "This study was funded by the Research Council of Norway (Project Grant 228919/H10) and the Northern Norway Regional Health Authority (Project Grants HST1117‐13 and HST1118‐13)."

CONFLICT OF INTEREST "The authors declare that they have no competing interests."

AECOPD: acute exacerbation of COPD; BMI: body mass index; CAT: COPD assessement test; CCQ: clinical COPD questionnaire; COPD: chronic obstructive pulmonary disease; CPET: cardiopulmonary exercise test; CRQ: chronic respiratory disease questionnaire; CT: computerised tomography; ECG: electrocardiogram; EE: energy expenditure; EPAP: expiratory positive airway pressure; ESWT: time walked on endurance shuttle walk test; EQ5D: EuroQol 5 dimensions questionnaire; FER: forced expiratory ratio; FEV1: forced expiratory volume in one second; GOLD: Global Initiative for Chronic Obstructive Lung Disease; HRQOL: health‐related quality of life; ICD‐10: International Statistical Classification of Diseases and Related Health Problems 10th Revision; ICS: inhaled corticosteriod; ILD: intersitial lung disease; IPAP: inspiratory positive airway pressure; ISWD: distance walked on incremental shuttle walk test; LABA: long‐acting beta2 agonist; LAMA: long‐acting muscarinic antagonist; LIPA: light intensity physical activity; LTOT: long term oxygen therapy; MRC: Medical Research Council; METs: metabolic equivalents; MVPA: moderate to vigorous physical activity; 1RM: one repetition maximum; PAL: physical activity level; Pimax: maximal inspiratory pressure; PR: pulmonary rehabilitation; RV: residual volume; SAE: serious adverse event; SF36: Medical Outcomes Survey 36‐item short‐form health survey questionnaire; SGRQ: St George's respiratory questionnaire; SpO2: oxygen saturation; 6MWD: distance walked on six‐minute walk test; 6MWT: six‐minute walk test; TLC: total lung capacity; VO2: peak oxygen uptake

Data and analyses

Open in table viewer
Comparison 1. Physical activity: intervention vs. no intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in step count (steps per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 1 change in step count (steps per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 1 change in step count (steps per day); Intervention: pulmonary rehabilitation/exercise training.

1.1 End intervention

3

180

Mean Difference (IV, Random, 95% CI)

208.24 [‐164.91, 581.39]

2 time/change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.2

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 2 time/change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 2 time/change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

2.1 End intervention

3

190

Mean Difference (IV, Random, 95% CI)

3.62 [‐1.90, 9.14]

3 change in time in light‐intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.3

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 3 change in time in light‐intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 3 change in time in light‐intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

3.1 End intervention

3

182

Mean Difference (IV, Random, 95% CI)

‐1.87 [‐28.35, 24.61]

4 change in total energy expenditure (kcal); Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.4

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 4 change in total energy expenditure (kcal); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 4 change in total energy expenditure (kcal); Intervention: pulmonary rehabilitation/exercise training.

4.1 End intervention

2

144

Mean Difference (IV, Random, 95% CI)

‐41.54 [‐89.97, 6.90]

5 change in time in physical activity (total; minutes per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.5

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 5 change in time in physical activity (total; minutes per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 5 change in time in physical activity (total; minutes per day); Intervention: pulmonary rehabilitation/exercise training.

5.1 End intervention

2

88

Mean Difference (IV, Random, 95% CI)

23.01 [6.12, 39.90]

6 change in sedentary time (minutes per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.6

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 6 change in sedentary time (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 6 change in sedentary time (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

6.1 End intervention

2

137

Mean Difference (IV, Random, 95% CI)

16.56 [‐27.06, 60.18]

7 time in "lifestyle" physical activity (minutes per day); Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.7

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 7 time in "lifestyle" physical activity (minutes per day); Intervention: high‐intensity interval training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 7 time in "lifestyle" physical activity (minutes per day); Intervention: high‐intensity interval training.

7.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

9.40 [3.87, 14.93]

8 time in light‐intensity physical activity (minutes per day); Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.8

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 8 time in light‐intensity physical activity (minutes per day); Intervention: high‐intensity interval training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 8 time in light‐intensity physical activity (minutes per day); Intervention: high‐intensity interval training.

8.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

28.12 [15.64, 40.60]

9 time in moderate‐to‐vigorous intensity physical activity (minutes per day); Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.9

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 9 time in moderate‐to‐vigorous intensity physical activity (minutes per day); Intervention: high‐intensity interval training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 9 time in moderate‐to‐vigorous intensity physical activity (minutes per day); Intervention: high‐intensity interval training.

9.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

6.24 [4.00, 8.48]

10 sedentary time (minutes per day); Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.10

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 10 sedentary time (minutes per day); Intervention: high‐intensity interval training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 10 sedentary time (minutes per day); Intervention: high‐intensity interval training.

10.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

‐34.25 [‐55.90, ‐12.60]

11 step count (steps per day); Intervention: physical activity counselling Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 1.11

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 11 step count (steps per day); Intervention: physical activity counselling.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 11 step count (steps per day); Intervention: physical activity counselling.

11.1 Step count: in‐person (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11.2 Change in step count: telecoaching (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11.3 Step count: 'Urban Training' (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12 "IMA" (counts per minute); Intervention: self‐management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 1.12

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 12 "IMA" (counts per minute); Intervention: self‐management.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 12 "IMA" (counts per minute); Intervention: self‐management.

12.1 Mid‐intervention (4 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.2 Mid‐intervention (12 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 physical activity level; Intervention: nutritional supplement Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 1.13

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 13 physical activity level; Intervention: nutritional supplement.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 13 physical activity level; Intervention: nutritional supplement.

13.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 total energy expenditure (MJ); Intervention: nutritional supplement Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 1.14

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 14 total energy expenditure (MJ); Intervention: nutritional supplement.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 14 total energy expenditure (MJ); Intervention: nutritional supplement.

14.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 subgroup analysis (supervised vs. unsupervised); change in step count (steps per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.15

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 15 subgroup analysis (supervised vs. unsupervised); change in step count (steps per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 15 subgroup analysis (supervised vs. unsupervised); change in step count (steps per day); Intervention: pulmonary rehabilitation/exercise training.

15.1 Supervised pulmonary rehabilitation/exercise training

2

144

Mean Difference (IV, Random, 95% CI)

68.86 [‐386.29, 524.01]

15.2 Unsupervised pulmonary rehabilitation/exercise training

1

36

Mean Difference (IV, Random, 95% CI)

494.0 [‐157.70, 1145.70]

16 supgroup analysis (supervised vs. unsupervised); change in time in light‐intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.16

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 16 supgroup analysis (supervised vs. unsupervised); change in time in light‐intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 16 supgroup analysis (supervised vs. unsupervised); change in time in light‐intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

16.1 Supervised pulmonary rehabilitation/exercise training

2

146

Mean Difference (IV, Random, 95% CI)

9.87 [‐9.22, 28.96]

16.2 Unupervised pulmonary rehabilitation/exercise training

1

36

Mean Difference (IV, Random, 95% CI)

‐44.0 [‐87.04, ‐0.96]

17 subgroup analysis (supervised vs. unsupervised); change in total energy expenditure (kcal); Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 1.17

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 17 subgroup analysis (supervised vs. unsupervised); change in total energy expenditure (kcal); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 17 subgroup analysis (supervised vs. unsupervised); change in total energy expenditure (kcal); Intervention: pulmonary rehabilitation/exercise training.

17.1 Supervised pulmonary rehabilitation/exercise training

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.2 Unsupervised pulmonary rehabilitation/exercise training

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18 subgroup analysis (supervised vs. unsupervised); change in sedentary time (minutes per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 1.18

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 18 subgroup analysis (supervised vs. unsupervised); change in sedentary time (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 18 subgroup analysis (supervised vs. unsupervised); change in sedentary time (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

18.1 Supervised pulmonary rehabilitation/exercise training

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18.2 Unsupervised pulmonary rehabilitation/exercise training

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 2. Physical activity: intervention vs. placebo/sham

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 step count (steps per day); Intervention: self‐management (health mentoring) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 2.1

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 1 step count (steps per day); Intervention: self‐management (health mentoring).

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 1 step count (steps per day); Intervention: self‐management (health mentoring).

1.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in step count (steps per day); Intervention: LAMA/LABA Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 2.2

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 2 change in step count (steps per day); Intervention: LAMA/LABA.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 2 change in step count (steps per day); Intervention: LAMA/LABA.

2.1 End intervention

2

426

Mean Difference (IV, Random, 95% CI)

531.30 [167.10, 895.49]

3 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day): Intervention: LAMA/LABA Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 2.3

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 3 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day): Intervention: LAMA/LABA.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 3 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day): Intervention: LAMA/LABA.

3.1 End intervention

2

423

Mean Difference (IV, Random, 95% CI)

9.74 [4.23, 15.24]

4 change in active energy expenditure (kcal); Intervention: LAMA/LABA Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 2.4

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 4 change in active energy expenditure (kcal); Intervention: LAMA/LABA.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 4 change in active energy expenditure (kcal); Intervention: LAMA/LABA.

4.1 End intervention

2

423

Mean Difference (IV, Random, 95% CI)

43.89 [17.92, 69.86]

5 step count (steps per day); Intervention: nutritional supplement Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 2.5

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 5 step count (steps per day); Intervention: nutritional supplement.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 5 step count (steps per day); Intervention: nutritional supplement.

5.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 energy expenditure for ambulation (kcal/step/FFM kg); Intervention: nutritional supplement Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 2.6

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 6 energy expenditure for ambulation (kcal/step/FFM kg); Intervention: nutritional supplement.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 6 energy expenditure for ambulation (kcal/step/FFM kg); Intervention: nutritional supplement.

6.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 change in step count (steps per day); Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 2.7

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 7 change in step count (steps per day); Intervention: neuromuscular electrical stimulation.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 7 change in step count (steps per day); Intervention: neuromuscular electrical stimulation.

7.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 change in up/down transitions (number); Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 2.8

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 8 change in up/down transitions (number); Intervention: neuromuscular electrical stimulation.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 8 change in up/down transitions (number); Intervention: neuromuscular electrical stimulation.

8.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9 change in time upright (hours); Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 2.9

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 9 change in time upright (hours); Intervention: neuromuscular electrical stimulation.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 9 change in time upright (hours); Intervention: neuromuscular electrical stimulation.

9.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 3. Physical activity: intervention with common intervention vs. common intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 movement intensity (m/s2); Interventions: nordic walking with education vs. education Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.1

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 1 movement intensity (m/s2); Interventions: nordic walking with education vs. education.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 1 movement intensity (m/s2); Interventions: nordic walking with education vs. education.

1.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Follow‐up (6 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Follow‐up (9 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in step count (steps per day); Interventions: exercise training (COPE‐active) with self‐management vs. self management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.2

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 2 change in step count (steps per day); Interventions: exercise training (COPE‐active) with self‐management vs. self management.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 2 change in step count (steps per day); Interventions: exercise training (COPE‐active) with self‐management vs. self management.

2.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Follow‐up (18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Follow‐up (24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in time in light‐intensity physical activity (minutes per day); Interventions: upper body resistance training with health education vs. health education Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.3

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 3 change in time in light‐intensity physical activity (minutes per day); Interventions: upper body resistance training with health education vs. health education.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 3 change in time in light‐intensity physical activity (minutes per day); Interventions: upper body resistance training with health education vs. health education.

3.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 step count (steps per day); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.4

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 4 step count (steps per day); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 4 step count (steps per day); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.

4.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 time walking (minutes per day); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.5

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 5 time walking (minutes per day); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 5 time walking (minutes per day); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.

5.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 walking intensity (m/s2); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.6

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 6 walking intensity (m/s2); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 6 walking intensity (m/s2); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.

6.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 step count (steps per day); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.7

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 7 step count (steps per day); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 7 step count (steps per day); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

7.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 time walking (minutes per day); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.8

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 8 time walking (minutes per day); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 8 time walking (minutes per day); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

8.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9 walking intensity (m/s2); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.9

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 9 walking intensity (m/s2); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 9 walking intensity (m/s2); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

9.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10 step count (steps per day); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.10

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 10 step count (steps per day); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 10 step count (steps per day); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

10.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11 time walking (minutes per day); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.11

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 11 time walking (minutes per day); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 11 time walking (minutes per day); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

11.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12 walking intensity (m/s2); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.12

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 12 walking intensity (m/s2); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 12 walking intensity (m/s2); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

12.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 change in step count (steps per day); Interventions: exercise training and physical activity counselling with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.13

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 13 change in step count (steps per day); Interventions: exercise training and physical activity counselling with pedometer vs. pedometer.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 13 change in step count (steps per day); Interventions: exercise training and physical activity counselling with pedometer vs. pedometer.

13.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 Follow‐up (3 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.3 Follow‐up (12 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 change in step count (weekday, steps per day); Interventions: physical activity counselling with optional supervised exercise vs. optional supervised exercise Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.14

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 14 change in step count (weekday, steps per day); Interventions: physical activity counselling with optional supervised exercise vs. optional supervised exercise.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 14 change in step count (weekday, steps per day); Interventions: physical activity counselling with optional supervised exercise vs. optional supervised exercise.

14.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.3 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 METs; Interventions: physical activity counselling with optional supervised exercise vs. optional supervised exercise Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.15

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 15 METs; Interventions: physical activity counselling with optional supervised exercise vs. optional supervised exercise.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 15 METs; Interventions: physical activity counselling with optional supervised exercise vs. optional supervised exercise.

15.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.3 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16 step count (steps per day); Interventions: physical activity counselling with pedometer vs. pedometer Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.16

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 16 step count (steps per day); Interventions: physical activity counselling with pedometer vs. pedometer.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 16 step count (steps per day); Interventions: physical activity counselling with pedometer vs. pedometer.

16.1 Step count: web‐based (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.2 Step count: app (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.3 Step count: app (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.4 Change in step count: web‐based (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.5 Change in step count: web‐based (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17 time active (minutes per day); Interventions: physical activity counselling (app) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.17

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 17 time active (minutes per day); Interventions: physical activity counselling (app) with pedometer vs. pedometer.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 17 time active (minutes per day); Interventions: physical activity counselling (app) with pedometer vs. pedometer.

17.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18 time inactive (minutes per day); Interventions: physical activity counselling (app) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.18

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 18 time inactive (minutes per day); Interventions: physical activity counselling (app) with pedometer vs. pedometer.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 18 time inactive (minutes per day); Interventions: physical activity counselling (app) with pedometer vs. pedometer.

18.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19 peak performance (steps per minute); Interventions: physical activity counselling (app) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.19

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 19 peak performance (steps per minute); Interventions: physical activity counselling (app) with pedometer vs. pedometer.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 19 peak performance (steps per minute); Interventions: physical activity counselling (app) with pedometer vs. pedometer.

19.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20 step count (steps per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.20

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 20 step count (steps per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 20 step count (steps per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

20.1 End intervention (7 days including PR)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.2 End intervention (6 days excluding PR)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.3 End intervention (4 days excluding PR)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.4 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.5 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21 time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.21

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 21 time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 21 time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

21.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22 time in physical activity (total, minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.22

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 22 time in physical activity (total, minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 22 time in physical activity (total, minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

22.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

23 time sedentary (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.23

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 23 time sedentary (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 23 time sedentary (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

23.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

23.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

24 change in step count (steps per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.24

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 24 change in step count (steps per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 24 change in step count (steps per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

24.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

24.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

25 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.25

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 25 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 25 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

25.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

25.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26 change in time walking (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.26

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 26 change in time walking (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 26 change in time walking (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

26.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27 change in time in physical activity (total, minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.27

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 27 change in time in physical activity (total, minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 27 change in time in physical activity (total, minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

27.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

28 change in time in light‐intensity physical activity (minutes per day); Interventions: exercise‐specific self‐efficacy training with upper body resistance training vs. upper body resistance training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.28

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 28 change in time in light‐intensity physical activity (minutes per day); Interventions: exercise‐specific self‐efficacy training with upper body resistance training vs. upper body resistance training.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 28 change in time in light‐intensity physical activity (minutes per day); Interventions: exercise‐specific self‐efficacy training with upper body resistance training vs. upper body resistance training.

28.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

28.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

29 step count (steps per day); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.29

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 29 step count (steps per day); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 29 step count (steps per day); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

29.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

29.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

30 time walking (minutes per day); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.30

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 30 time walking (minutes per day); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 30 time walking (minutes per day); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

30.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

30.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

31 walking intensity (m/s2); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.31

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 31 walking intensity (m/s2); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 31 walking intensity (m/s2); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

31.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

31.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

32 step count (steps per day); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.32

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 32 step count (steps per day); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 32 step count (steps per day); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

32.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

32.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

33 time walking (minutes per day); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.33

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 33 time walking (minutes per day); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 33 time walking (minutes per day); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

33.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

33.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

34 walking intensity (m/s2); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.34

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 34 walking intensity (m/s2); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 34 walking intensity (m/s2); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

34.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

34.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

35 step count (steps per day); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.35

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 35 step count (steps per day); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 35 step count (steps per day); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

35.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

35.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

36 time walking (minutes per day); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.36

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 36 time walking (minutes per day); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 36 time walking (minutes per day); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

36.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

36.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

37 walking intensity (m/s2); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.37

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 37 walking intensity (m/s2); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 37 walking intensity (m/s2); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

37.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

37.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

38 change in step count (steps per day); Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.38

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 38 change in step count (steps per day); Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 38 change in step count (steps per day); Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.

38.1 End intervention (stage 1)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

38.2 End intervention (stage 2)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

38.3 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

39 change in step count (steps per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.39

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 39 change in step count (steps per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 39 change in step count (steps per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

39.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

39.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

40 change in time in moderate‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.40

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 40 change in time in moderate‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 40 change in time in moderate‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

40.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

40.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

41 change in time in vigorous‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.41

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 41 change in time in vigorous‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 41 change in time in vigorous‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

41.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

41.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

42 change in time in light‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.42

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 42 change in time in light‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 42 change in time in light‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

42.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

42.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

43 change in total energy expenditure (kcal); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.43

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 43 change in total energy expenditure (kcal); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 43 change in total energy expenditure (kcal); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

43.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

43.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

44 change in sedentary time (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 3.44

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 44 change in sedentary time (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 44 change in sedentary time (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

44.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

44.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 4. Physical activity: intervention vs. intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in step count (steps per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.1

Comparison 4 Physical activity: intervention vs. intervention, Outcome 1 change in step count (steps per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 1 change in step count (steps per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

1.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.2

Comparison 4 Physical activity: intervention vs. intervention, Outcome 2 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 2 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

2.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in number of bouts of moderate‐to‐vigorous intensity physical activity; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.3

Comparison 4 Physical activity: intervention vs. intervention, Outcome 3 change in number of bouts of moderate‐to‐vigorous intensity physical activity; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 3 change in number of bouts of moderate‐to‐vigorous intensity physical activity; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

3.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 change in time in bouts of moderate‐to‐vigorous intensity physical activity(minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.4

Comparison 4 Physical activity: intervention vs. intervention, Outcome 4 change in time in bouts of moderate‐to‐vigorous intensity physical activity(minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 4 change in time in bouts of moderate‐to‐vigorous intensity physical activity(minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

4.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 change in sedentary time (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.5

Comparison 4 Physical activity: intervention vs. intervention, Outcome 5 change in sedentary time (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 5 change in sedentary time (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

5.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 change in sedentary time (awake; minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.6

Comparison 4 Physical activity: intervention vs. intervention, Outcome 6 change in sedentary time (awake; minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 6 change in sedentary time (awake; minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

6.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 change in number of sedentary bouts; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.7

Comparison 4 Physical activity: intervention vs. intervention, Outcome 7 change in number of sedentary bouts; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 7 change in number of sedentary bouts; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

7.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 change in time in sedentary bouts (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.8

Comparison 4 Physical activity: intervention vs. intervention, Outcome 8 change in time in sedentary bouts (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 8 change in time in sedentary bouts (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

8.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9 change in METs; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.9

Comparison 4 Physical activity: intervention vs. intervention, Outcome 9 change in METs; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 9 change in METs; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

9.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10 change in total energy expenditure (kcal); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.10

Comparison 4 Physical activity: intervention vs. intervention, Outcome 10 change in total energy expenditure (kcal); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 10 change in total energy expenditure (kcal); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

10.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11 change in step count (steps per day); Interventions: water‐based exercise training vs. land‐based exercise training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.11

Comparison 4 Physical activity: intervention vs. intervention, Outcome 11 change in step count (steps per day); Interventions: water‐based exercise training vs. land‐based exercise training.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 11 change in step count (steps per day); Interventions: water‐based exercise training vs. land‐based exercise training.

11.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12 change in total energy expenditure (kcal); Interventions: water‐based exercise training vs. land‐based exercise training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.12

Comparison 4 Physical activity: intervention vs. intervention, Outcome 12 change in total energy expenditure (kcal); Interventions: water‐based exercise training vs. land‐based exercise training.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 12 change in total energy expenditure (kcal); Interventions: water‐based exercise training vs. land‐based exercise training.

12.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 step count (steps per day); Interventions: Tai Chi vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.13

Comparison 4 Physical activity: intervention vs. intervention, Outcome 13 step count (steps per day); Interventions: Tai Chi vs. pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 13 step count (steps per day); Interventions: Tai Chi vs. pulmonary rehabilitation.

13.1 Mid‐intervention (6 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 Mid‐intervention (22 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 step count (steps per day); Interventions: outdoor walking vs. cycle ergometry Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.14

Comparison 4 Physical activity: intervention vs. intervention, Outcome 14 step count (steps per day); Interventions: outdoor walking vs. cycle ergometry.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 14 step count (steps per day); Interventions: outdoor walking vs. cycle ergometry.

14.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 step count (steps per day); Interventions: physical activity counselling vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.15

Comparison 4 Physical activity: intervention vs. intervention, Outcome 15 step count (steps per day); Interventions: physical activity counselling vs. pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 15 step count (steps per day); Interventions: physical activity counselling vs. pulmonary rehabilitation.

15.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16 total energy expenditure (kcal); Interventions: exercise training with tapered supervision vs. supervised exercise training Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 4.16

Comparison 4 Physical activity: intervention vs. intervention, Outcome 16 total energy expenditure (kcal); Interventions: exercise training with tapered supervision vs. supervised exercise training.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 16 total energy expenditure (kcal); Interventions: exercise training with tapered supervision vs. supervised exercise training.

16.1 End intervention

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.2 Follow‐up

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

17 mid day activity (vector magnitude units per minute); Interventions: supplemental oxygen (lightweight ambulatory) vs. supplemental oxygen (E‐cylinder) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 4.17

Comparison 4 Physical activity: intervention vs. intervention, Outcome 17 mid day activity (vector magnitude units per minute); Interventions: supplemental oxygen (lightweight ambulatory) vs. supplemental oxygen (E‐cylinder).

Comparison 4 Physical activity: intervention vs. intervention, Outcome 17 mid day activity (vector magnitude units per minute); Interventions: supplemental oxygen (lightweight ambulatory) vs. supplemental oxygen (E‐cylinder).

17.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 5. Health‐related quality of life: intervention vs. no intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in SGRQ total score; Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 5.1

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 1 change in SGRQ total score; Intervention: pulmonary rehabilitation/exercise training.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 1 change in SGRQ total score; Intervention: pulmonary rehabilitation/exercise training.

1.1 End intervention

2

144

Mean Difference (IV, Random, 95% CI)

‐8.79 [‐14.08, ‐3.51]

2 change in SGRQ domain scores. Intervention: pulmonary rehabilitation/exercise training (ground‐based walking) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.2

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 2 change in SGRQ domain scores. Intervention: pulmonary rehabilitation/exercise training (ground‐based walking).

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 2 change in SGRQ domain scores. Intervention: pulmonary rehabilitation/exercise training (ground‐based walking).

2.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in CRQ domain scores; Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 5.3

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 3 change in CRQ domain scores; Intervention: pulmonary rehabilitation/exercise training.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 3 change in CRQ domain scores; Intervention: pulmonary rehabilitation/exercise training.

3.1 Dyspnoea (end intervention)

3

182

Mean Difference (IV, Random, 95% CI)

1.69 [0.02, 3.36]

3.2 Emotional function (end intervention)

3

182

Mean Difference (IV, Random, 95% CI)

2.41 [0.48, 4.35]

3.3 Fatigue (end intervention)

3

182

Mean Difference (IV, Random, 95% CI)

1.34 [‐0.16, 2.83]

3.4 Mastery (end intervention)

3

182

Mean Difference (IV, Random, 95% CI)

0.61 [‐0.47, 1.69]

3.5 Total score (end intervention)

3

182

Mean Difference (IV, Random, 95% CI)

6.70 [2.55, 10.86]

4 CAT score; Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 5.4

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 4 CAT score; Intervention: high‐intensity interval training.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 4 CAT score; Intervention: high‐intensity interval training.

4.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

‐3.15 [‐4.82, ‐1.47]

5 SGRQ domain scores (%change); Intervention: exercise training [inpatient] Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.5

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 5 SGRQ domain scores (%change); Intervention: exercise training [inpatient].

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 5 SGRQ domain scores (%change); Intervention: exercise training [inpatient].

5.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.4 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.5 Symptoms (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.6 Activity (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.7 Impacts (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.8 Total score (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 SGRQ domain scores; Intervention: physical activity counselling Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.6

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 6 SGRQ domain scores; Intervention: physical activity counselling.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 6 SGRQ domain scores; Intervention: physical activity counselling.

6.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.4 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 CCQ domain scores: Intervention: physical activity counselling Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.7

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 7 CCQ domain scores: Intervention: physical activity counselling.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 7 CCQ domain scores: Intervention: physical activity counselling.

7.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Functional state (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Mental state (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.4 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 change in CCQ domain scores; Intervention: physical activity counselling (telecoaching) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.8

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 8 change in CCQ domain scores; Intervention: physical activity counselling (telecoaching).

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 8 change in CCQ domain scores; Intervention: physical activity counselling (telecoaching).

8.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Functional state (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Mental state (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9 change in CRQ domain and total scores; Intervention: physical activity counselling Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.9

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 9 change in CRQ domain and total scores; Intervention: physical activity counselling.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 9 change in CRQ domain and total scores; Intervention: physical activity counselling.

9.1 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.5 Total (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10 change in SGRQ domain and total scores; Intervention: physical activity counselling Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.10

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 10 change in SGRQ domain and total scores; Intervention: physical activity counselling.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 10 change in SGRQ domain and total scores; Intervention: physical activity counselling.

10.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Total (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11 change in CRQ domain scores; Intervention: self‐management (SPACE) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.11

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 11 change in CRQ domain scores; Intervention: self‐management (SPACE).

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 11 change in CRQ domain scores; Intervention: self‐management (SPACE).

11.1 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.2 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.5 Dyspnoea (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.6 Emotional domain (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.7 Fatigue (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.8 Mastery (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12 CCQ total score; Intervention: self‐management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.12

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 12 CCQ total score; Intervention: self‐management.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 12 CCQ total score; Intervention: self‐management.

12.1 Mid‐intervention (4 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.2 Mid‐intervention (12 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 EQ5D index score; Intervention: self‐management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.13

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 13 EQ5D index score; Intervention: self‐management.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 13 EQ5D index score; Intervention: self‐management.

13.1 Mid‐intervention (4 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 Mid‐intervention (12 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 EQ5D visual analogue scale score; Intervention: self‐management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.14

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 14 EQ5D visual analogue scale score; Intervention: self‐management.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 14 EQ5D visual analogue scale score; Intervention: self‐management.

14.1 Mid‐intervention (4 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 Mid‐intervention (12 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 SGRQ domain scores; Intervention: self‐management (telephone health coaching) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.15

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 15 SGRQ domain scores; Intervention: self‐management (telephone health coaching).

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 15 SGRQ domain scores; Intervention: self‐management (telephone health coaching).

15.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.4 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.5 Symptoms (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.6 Activity (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.7 Impacts (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.8 Total score (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16 EQ5D score; Intervention: self‐management (telephone health coaching) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.16

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 16 EQ5D score; Intervention: self‐management (telephone health coaching).

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 16 EQ5D score; Intervention: self‐management (telephone health coaching).

16.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17 CRQ domain scores; Intervention: four‐wheeled walker Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.17

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 17 CRQ domain scores; Intervention: four‐wheeled walker.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 17 CRQ domain scores; Intervention: four‐wheeled walker.

17.1 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.2 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 6. Health‐related quality of life: intervention vs. placebo/sham

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in SF36 component scores; Intervention: singing Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 6.1

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 1 change in SF36 component scores; Intervention: singing.

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 1 change in SF36 component scores; Intervention: singing.

1.1 Physical component (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Mental component (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in CRQ total score; Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 6.2

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 2 change in CRQ total score; Intervention: neuromuscular electrical stimulation.

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 2 change in CRQ total score; Intervention: neuromuscular electrical stimulation.

2.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in SGRQ total score; Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 6.3

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 3 change in SGRQ total score; Intervention: neuromuscular electrical stimulation.

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 3 change in SGRQ total score; Intervention: neuromuscular electrical stimulation.

3.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 change in EQ5D index score; Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 6.4

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 4 change in EQ5D index score; Intervention: neuromuscular electrical stimulation.

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 4 change in EQ5D index score; Intervention: neuromuscular electrical stimulation.

4.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 change in EQ5D visual analogue scale score; Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 6.5

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 5 change in EQ5D visual analogue scale score; Intervention: neuromuscular electrical stimulation.

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 5 change in EQ5D visual analogue scale score; Intervention: neuromuscular electrical stimulation.

5.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 7. Health‐related quality of life: intervention with common intervention vs. common intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 SF36 component scores (score < 50); Interventions: Nordic walking with education vs. education Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.1

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 1 SF36 component scores (score < 50); Interventions: Nordic walking with education vs. education.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 1 SF36 component scores (score < 50); Interventions: Nordic walking with education vs. education.

1.1 Physical component score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Physical component score (follow‐up, 6 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Physical component score (follow‐up, 9 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Mental component score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.5 Mental component score (follow‐up, 6 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.6 Mental component score (follow‐up, 9 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in CRQ domain scores; Interventions: exercise training (COPE‐active) with self‐management vs. self management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.2

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 2 change in CRQ domain scores; Interventions: exercise training (COPE‐active) with self‐management vs. self management.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 2 change in CRQ domain scores; Interventions: exercise training (COPE‐active) with self‐management vs. self management.

2.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.6 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.9 Dyspnoea (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.10 Emotional function (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.11 Fatigue (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.12 Mastery (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.13 Dyspnoea (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.14 Emotional function (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.15 Fatigue (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.16 Mastery (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in CCQ domain scores; Interventions: exercise training (COPE‐active) with self‐management vs. self management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.3

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 3 change in CCQ domain scores; Interventions: exercise training (COPE‐active) with self‐management vs. self management.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 3 change in CCQ domain scores; Interventions: exercise training (COPE‐active) with self‐management vs. self management.

3.1 Symptoms (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Functional state (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Mental state (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Total (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Functional state (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.7 Mental state (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Total (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Symptoms (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Functional state (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.11 Mental state (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.12 Total (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.13 Symptoms (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.14 Functional state (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.15 Mental state (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.16 Total (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 CRQ domain scores; Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.4

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 4 CRQ domain scores; Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 4 CRQ domain scores; Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.

4.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 CRQ domain scores; Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.5

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 5 CRQ domain scores; Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 5 CRQ domain scores; Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

5.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.3 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.6 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 CRQ domain scores; Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.6

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 6 CRQ domain scores; Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 6 CRQ domain scores; Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

6.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.6 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 change in SGRQ domain and total scores; Intervention: exercise training and physical activity counselling with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.7

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 7 change in SGRQ domain and total scores; Intervention: exercise training and physical activity counselling with pedometer vs. pedometer.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 7 change in SGRQ domain and total scores; Intervention: exercise training and physical activity counselling with pedometer vs. pedometer.

7.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.4 Total (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.5 Symptoms (follow‐up, 3 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.6 Activity (follow‐up, 3 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.7 Impacts (follow‐up, 3 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.8 Total (follow‐up, 3 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.9 Symptoms (follow‐up, 12 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.10 Activity (follow‐up, 12 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.11 Impacts (follow‐up, 12 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.12 Total (follow‐up, 12 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 change in CRQ domain scores; Interventions: physical activity counselling (app) with optional supervised exercise vs. optional supervised exercise Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.8

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 8 change in CRQ domain scores; Interventions: physical activity counselling (app) with optional supervised exercise vs. optional supervised exercise.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 8 change in CRQ domain scores; Interventions: physical activity counselling (app) with optional supervised exercise vs. optional supervised exercise.

8.1 Dyspnoea (12 weeks, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Emotional function (12 weeks, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Fatigue (12 weeks, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.4 Mastery (12 weeks, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.5 Dyspnoea (6 months, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.6 Emotional function (6 months, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.7 Fatigue (6 months, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.8 Mastery (6 months, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.9 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.10 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.11 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.12 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9 change in SGRQ total score; Interventions: physical activity counselling with pedometer vs. pedometer Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.9

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 9 change in SGRQ total score; Interventions: physical activity counselling with pedometer vs. pedometer.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 9 change in SGRQ total score; Interventions: physical activity counselling with pedometer vs. pedometer.

9.1 web‐based (12 weeks, end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 web‐based (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.3 web‐based (12 months, end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10 SGRQ total: Interventions: physical activity counselling (app) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.10

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 10 SGRQ total: Interventions: physical activity counselling (app) with pedometer vs. pedometer.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 10 SGRQ total: Interventions: physical activity counselling (app) with pedometer vs. pedometer.

10.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11 SF36: Interventions: physical activity counselling (app) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.11

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 11 SF36: Interventions: physical activity counselling (app) with pedometer vs. pedometer.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 11 SF36: Interventions: physical activity counselling (app) with pedometer vs. pedometer.

11.1 Physical component score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.2 Mental component score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12 change in SGRQ domain scores; Interventions: physical activity counselling (web‐based) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.12

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 12 change in SGRQ domain scores; Interventions: physical activity counselling (web‐based) with pedometer vs. pedometer.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 12 change in SGRQ domain scores; Interventions: physical activity counselling (web‐based) with pedometer vs. pedometer.

12.1 Symptoms (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.2 Impacts (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.3 Activities (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.4 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.5 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.6 Activities (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 SGRQ domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.13

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 13 SGRQ domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 13 SGRQ domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

13.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 RAND36 domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.14

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 14 RAND36 domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 14 RAND36 domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

14.1 Physical function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 Vitality (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.3 Bodily pain (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.4 General health perception (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.5 Health status (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 change in CRQ dyspnoea domain score; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.15

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 15 change in CRQ dyspnoea domain score; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 15 change in CRQ dyspnoea domain score; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

15.1 Mid‐intervention (end PR)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16 SGRQ scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.16

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 16 SGRQ scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 16 SGRQ scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

16.1 Symptoms (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.2 Activity (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.3 Impacts (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.4 Total score (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.5 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.6 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.7 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.8 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17 CRQ domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.17

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 17 CRQ domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 17 CRQ domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

17.1 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.2 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.5 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18 change in CRQ total score; Interventions: physical activity counselling with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.18

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 18 change in CRQ total score; Interventions: physical activity counselling with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 18 change in CRQ total score; Interventions: physical activity counselling with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.

18.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19 change in CRQ scores; Interventions: self‐management (health coaching) with pulmonary rehabilitation referral vs. pulmonary rehabilitation referral Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.19

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 19 change in CRQ scores; Interventions: self‐management (health coaching) with pulmonary rehabilitation referral vs. pulmonary rehabilitation referral.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 19 change in CRQ scores; Interventions: self‐management (health coaching) with pulmonary rehabilitation referral vs. pulmonary rehabilitation referral.

19.1 Physical function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19.2 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19.3 Physical function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19.4 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20 CRQ domain scores; Interventions: LAMA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.20

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 20 CRQ domain scores; Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 20 CRQ domain scores; Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

20.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.2 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.3 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.6 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21 CRQ domain scores; Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.21

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 21 CRQ domain scores; Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 21 CRQ domain scores; Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

21.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.2 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.3 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.6 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22 CRQ domain scores; Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.22

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 22 CRQ domain scores; Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 22 CRQ domain scores; Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

22.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.2 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.3 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.6 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

23 change in SGRQ domain and total scores; Interventions: ACE inhibitor with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 7.23

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 23 change in SGRQ domain and total scores; Interventions: ACE inhibitor with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 23 change in SGRQ domain and total scores; Interventions: ACE inhibitor with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.

23.1 Symptoms (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

23.2 Activity (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

23.3 Impacts (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

23.4 Total (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

24 change in SGRQ total score; Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.24

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 24 change in SGRQ total score; Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 24 change in SGRQ total score; Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.

24.1 End intervention (stage 2)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

24.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

25 change in EQ5D; Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.25

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 25 change in EQ5D; Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 25 change in EQ5D; Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.

25.1 End intervention (stage 2)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

25.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26 change in CRQ domain scores; Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.26

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 26 change in CRQ domain scores; Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 26 change in CRQ domain scores; Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.

26.1 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.2 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.5 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.6 Dyspnoea (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.7 Emotional function (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.8 Fatigue (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.9 Mastery (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.10 Total score (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27 CRQ domain scores; Interventions: non‐invasive ventilation with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 7.27

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 27 CRQ domain scores; Interventions: non‐invasive ventilation with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 27 CRQ domain scores; Interventions: non‐invasive ventilation with pulmonary rehabilitation vs. pulmonary rehabilitation.

27.1 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27.2 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27.5 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 8. Exercise capacity: intervention vs. placebo/sham

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in 6MWD (metres); Intervention; neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 8.1

Comparison 8 Exercise capacity: intervention vs. placebo/sham, Outcome 1 change in 6MWD (metres); Intervention; neuromuscular electrical stimulation.

Comparison 8 Exercise capacity: intervention vs. placebo/sham, Outcome 1 change in 6MWD (metres); Intervention; neuromuscular electrical stimulation.

1.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 9. Exercise capacity: intervention vs. no intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in 6MWD (metres); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 9.1

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 1 change in 6MWD (metres); Intervention: pulmonary rehabilitation/exercise training.

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 1 change in 6MWD (metres); Intervention: pulmonary rehabilitation/exercise training.

1.1 End intervention

3

182

Mean Difference (IV, Random, 95% CI)

29.06 [14.38, 43.75]

2 change in ISWD (metres); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 9.2

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 2 change in ISWD (metres); Intervention: pulmonary rehabilitation/exercise training.

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 2 change in ISWD (metres); Intervention: pulmonary rehabilitation/exercise training.

2.1 End intervention

3

180

Mean Difference (IV, Random, 95% CI)

19.02 [2.20, 35.85]

3 change in ESWT (seconds); Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 9.3

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 3 change in ESWT (seconds); Intervention: pulmonary rehabilitation/exercise training.

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 3 change in ESWT (seconds); Intervention: pulmonary rehabilitation/exercise training.

3.1 End intervention

2

137

Mean Difference (IV, Random, 95% CI)

237.87 [147.59, 328.16]

4 6MWD (metres); Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 9.4

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 4 6MWD (metres); Intervention: high‐intensity interval training.

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 4 6MWD (metres); Intervention: high‐intensity interval training.

4.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

46.55 [24.66, 68.45]

5 work rate (watts); Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 9.5

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 5 work rate (watts); Intervention: high‐intensity interval training.

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 5 work rate (watts); Intervention: high‐intensity interval training.

5.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

15.47 [8.76, 22.17]

6 change in ISWD (metres); Intervention: self‐management (SPACE) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 9.6

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 6 change in ISWD (metres); Intervention: self‐management (SPACE).

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 6 change in ISWD (metres); Intervention: self‐management (SPACE).

6.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 change in ESWT (seconds); Intervention: self‐management (SPACE) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 9.7

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 7 change in ESWT (seconds); Intervention: self‐management (SPACE).

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 7 change in ESWT (seconds); Intervention: self‐management (SPACE).

7.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 6MWD (metres); Intervention: exercise training [inpatient] Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 9.8

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 8 6MWD (metres); Intervention: exercise training [inpatient].

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 8 6MWD (metres); Intervention: exercise training [inpatient].

8.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 10. Health‐related quality of life: intervention vs. intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in CRQ domains; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 10.1

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 1 change in CRQ domains; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 1 change in CRQ domains; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

1.1 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.5 Dyspnoea (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.6 Emotional function (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.7 Fatigue (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.8 Mastery (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in CRQ domains; Interventions: water‐based exercise training vs. land‐based exercise training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 10.2

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 2 change in CRQ domains; Interventions: water‐based exercise training vs. land‐based exercise training.

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 2 change in CRQ domains; Interventions: water‐based exercise training vs. land‐based exercise training.

2.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.5 Total score (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.6 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.8 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.9 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.10 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 SGRQ domain and total scores; Interventions: Tai Chi vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 10.3

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 3 SGRQ domain and total scores; Interventions: Tai Chi vs. pulmonary rehabilitation.

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 3 SGRQ domain and total scores; Interventions: Tai Chi vs. pulmonary rehabilitation.

3.1 Symptoms (mid‐intervention, 2 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Activity (mid‐intervention, 2 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Impacts (mid‐intervention, 2 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Total (mid‐intervention, 2 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Symptoms (mid‐intervention, 14 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Activity (mid‐intervention, 14 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.7 Impacts (mid‐intervention, 14 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Total (mid‐intervention, 14 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.11 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.12 Total (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 CRQ total score; Interventions: outdoor walking vs. cycle ergometry Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 10.4

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 4 CRQ total score; Interventions: outdoor walking vs. cycle ergometry.

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 4 CRQ total score; Interventions: outdoor walking vs. cycle ergometry.

4.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Maugeri Respiratory Failure questionnaire; Interventions: exercise training with tapered supervision vs. supervised exercise training Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.5

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 5 Maugeri Respiratory Failure questionnaire; Interventions: exercise training with tapered supervision vs. supervised exercise training.

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 5 Maugeri Respiratory Failure questionnaire; Interventions: exercise training with tapered supervision vs. supervised exercise training.

5.1 End intervention

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 Follow‐up

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 SF36 domain scores; Interventions: self‐management vs. education and symptom monitoring Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 10.6

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 6 SF36 domain scores; Interventions: self‐management vs. education and symptom monitoring.

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 6 SF36 domain scores; Interventions: self‐management vs. education and symptom monitoring.

6.1 Mental health (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Role emotional (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Vitality (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.4 Social functioning (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.5 Pain (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.6 Role physical (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.7 General health (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.8 Physical functioning (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 11. Exercise capacity: intervention with common intervention vs. common intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 6MWD (metres); Interventions: Nordic walking with education vs. education Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.1

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 1 6MWD (metres); Interventions: Nordic walking with education vs. education.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 1 6MWD (metres); Interventions: Nordic walking with education vs. education.

1.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Follow‐up (6 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Follow‐up (9 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in ISWD (metres); Interventions: exercise training (COPE‐active) with self‐management vs. self management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.2

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 2 change in ISWD (metres); Interventions: exercise training (COPE‐active) with self‐management vs. self management.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 2 change in ISWD (metres); Interventions: exercise training (COPE‐active) with self‐management vs. self management.

2.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Follow‐up (18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Follow‐up (24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in ESWT (seconds); Interventions: exercise training (COPE‐active) with self‐management vs. self management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.3

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 3 change in ESWT (seconds); Interventions: exercise training (COPE‐active) with self‐management vs. self management.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 3 change in ESWT (seconds); Interventions: exercise training (COPE‐active) with self‐management vs. self management.

3.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Follow‐up (18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Follow‐up (24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 6MWD (metres); Interventions: exercise training and LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.4

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 4 6MWD (metres); Interventions: exercise training and LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 4 6MWD (metres); Interventions: exercise training and LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

4.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 ESWT (seconds); Interventions: exercise training and LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.5

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 5 ESWT (seconds); Interventions: exercise training and LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 5 ESWT (seconds); Interventions: exercise training and LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

5.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 6MWD (metres); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.6

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 6 6MWD (metres); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 6 6MWD (metres); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

6.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 ESWT (seconds); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.7

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 7 ESWT (seconds); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 7 ESWT (seconds); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

7.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 6MWD (metres); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.8

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 8 6MWD (metres); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 8 6MWD (metres); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

8.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9 ESWT (seconds); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.9

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 9 ESWT (seconds); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 9 ESWT (seconds); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

9.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10 change in ESWT (seconds); Intervention: physical activity counselling and exercise training with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.10

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 10 change in ESWT (seconds); Intervention: physical activity counselling and exercise training with pedometer vs. pedometer.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 10 change in ESWT (seconds); Intervention: physical activity counselling and exercise training with pedometer vs. pedometer.

10.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Follow‐up (3 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Follow‐up (12 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11 6MWD (metres); Interventions: physical activity counselling (app) with optional supervised exercise vs. optional supervised exercise Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.11

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 11 6MWD (metres); Interventions: physical activity counselling (app) with optional supervised exercise vs. optional supervised exercise.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 11 6MWD (metres); Interventions: physical activity counselling (app) with optional supervised exercise vs. optional supervised exercise.

11.1 Mid‐intervention (12 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.2 Mid‐intervention (6 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.3 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12 6MWD (metres); Interventions: physical activity counselling (app) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.12

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 12 6MWD (metres); Interventions: physical activity counselling (app) with pedometer vs. pedometer.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 12 6MWD (metres); Interventions: physical activity counselling (app) with pedometer vs. pedometer.

12.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 6MWD (metres); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.13

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 13 6MWD (metres); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 13 6MWD (metres); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

13.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 change in 6MWD (metres); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.14

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 14 change in 6MWD (metres); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 14 change in 6MWD (metres); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

14.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 6MWD (metres); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.15

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 15 6MWD (metres); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 15 6MWD (metres); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

15.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16 ESWT (seconds); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.16

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 16 ESWT (seconds); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 16 ESWT (seconds); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

16.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17 6MWD (metres); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.17

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 17 6MWD (metres); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 17 6MWD (metres); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

17.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18 ESWT (s); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.18

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 18 ESWT (s); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 18 ESWT (s); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

18.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19 6MWD (metres); Interventions: LAMA/LABA with behaviour modification vs. LAMA with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.19

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 19 6MWD (metres); Interventions: LAMA/LABA with behaviour modification vs. LAMA with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 19 6MWD (metres); Interventions: LAMA/LABA with behaviour modification vs. LAMA with behaviour modification.

19.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20 ESWT (seconds); Interventions: LAMA/LABA with behaviour modification vs. LAMA with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.20

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 20 ESWT (seconds); Interventions: LAMA/LABA with behaviour modification vs. LAMA with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 20 ESWT (seconds); Interventions: LAMA/LABA with behaviour modification vs. LAMA with behaviour modification.

20.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21 change in ISWD (metres); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.21

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 21 change in ISWD (metres); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 21 change in ISWD (metres); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.

21.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22 change in ESWT (seconds); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.22

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 22 change in ESWT (seconds); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 22 change in ESWT (seconds); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.

22.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 12. Exercise capacity: intervention vs. intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in 6MWD (metres); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 12.1

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 1 change in 6MWD (metres); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 1 change in 6MWD (metres); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

1.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in 6MWD (metres); Interventions: water‐based exercise training vs. land‐based exercise training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 12.2

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 2 change in 6MWD (metres); Interventions: water‐based exercise training vs. land‐based exercise training.

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 2 change in 6MWD (metres); Interventions: water‐based exercise training vs. land‐based exercise training.

2.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in ISWD (metres); Interventions: water‐based exercise training vs. land‐based exercise training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 12.3

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 3 change in ISWD (metres); Interventions: water‐based exercise training vs. land‐based exercise training.

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 3 change in ISWD (metres); Interventions: water‐based exercise training vs. land‐based exercise training.

3.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 change in VO2max (ml/min); Interventions: water‐based exercise training vs. land‐based exercise training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 12.4

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 4 change in VO2max (ml/min); Interventions: water‐based exercise training vs. land‐based exercise training.

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 4 change in VO2max (ml/min); Interventions: water‐based exercise training vs. land‐based exercise training.

4.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 6MWD (metres); Interventions: Tai Chi vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 12.5

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 5 6MWD (metres); Interventions: Tai Chi vs. pulmonary rehabilitation.

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 5 6MWD (metres); Interventions: Tai Chi vs. pulmonary rehabilitation.

5.1 Mid‐intervention (2 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Mid‐intervention (14 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.3 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 6MWD (metres); Interventions: exercise training with tapered supervision vs. supervised exercise training Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 12.6

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 6 6MWD (metres); Interventions: exercise training with tapered supervision vs. supervised exercise training.

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 6 6MWD (metres); Interventions: exercise training with tapered supervision vs. supervised exercise training.

6.1 End intervention

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Follow‐up

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Forest plot of comparison 1: Intervention vs. no interventionOutcome 1.1: Physical activity: change in step count (steps per day)
Figuras y tablas -
Figure 3

Forest plot of comparison 1: Intervention vs. no intervention

Outcome 1.1: Physical activity: change in step count (steps per day)

Forest plot of comparison 1: Intervention vs. no interventionOutcome 1.2: Physical activity: change in time in moderate‐to‐vigorous intensity physical activity (minutes per day)
Figuras y tablas -
Figure 4

Forest plot of comparison 1: Intervention vs. no intervention

Outcome 1.2: Physical activity: change in time in moderate‐to‐vigorous intensity physical activity (minutes per day)

Forest plot of comparison 1: Intervention vs. no interventionOutcome 1.4: Physical activity: change in time in light‐intensity physical activity (minutes per day)
Figuras y tablas -
Figure 5

Forest plot of comparison 1: Intervention vs. no intervention

Outcome 1.4: Physical activity: change in time in light‐intensity physical activity (minutes per day)

Forest plot of comparison 1: Intervention vs. no interventionOutcome 1.3: Physical activity: change in total energy expenditure (kcal)
Figuras y tablas -
Figure 6

Forest plot of comparison 1: Intervention vs. no intervention

Outcome 1.3: Physical activity: change in total energy expenditure (kcal)

Forest plot of comparison 1: Intervention vs. no interventionOutcome 1.6: Physical activity: change in time in physical activity (total, minutes per day)
Figuras y tablas -
Figure 7

Forest plot of comparison 1: Intervention vs. no intervention

Outcome 1.6: Physical activity: change in time in physical activity (total, minutes per day)

Forest plot of comparison 1: Intervention vs. no interventionOutcome 1.5: Physical activity: change in sedentary time (minutes per day)
Figuras y tablas -
Figure 8

Forest plot of comparison 1: Intervention vs. no intervention

Outcome 1.5: Physical activity: change in sedentary time (minutes per day)

Forest plot of comparison 1: Intervention vs. no interventionOutcome: 1.8 Physical activity: time in "lifestyle" physical activity (minutes per day)
Figuras y tablas -
Figure 9

Forest plot of comparison 1: Intervention vs. no intervention

Outcome: 1.8 Physical activity: time in "lifestyle" physical activity (minutes per day)

Forest plot of comparison: 1 Intervention vs. no interventionOutcome: 1.7 Physical activity: time in light‐intensity physical activity (minutes per day)
Figuras y tablas -
Figure 10

Forest plot of comparison: 1 Intervention vs. no intervention

Outcome: 1.7 Physical activity: time in light‐intensity physical activity (minutes per day)

Forest plot of comparison 1: Intervention vs. vs. no interventionOutcome 1.9: Physical activity: time in MVPA (minutes per day)
Figuras y tablas -
Figure 11

Forest plot of comparison 1: Intervention vs. vs. no intervention

Outcome 1.9: Physical activity: time in MVPA (minutes per day)

Forest plot of comparison 1: Intervention vs. no interventionOutcome 1.10: Physical activity: sedentary time (minutes per day)
Figuras y tablas -
Figure 12

Forest plot of comparison 1: Intervention vs. no intervention

Outcome 1.10: Physical activity: sedentary time (minutes per day)

Forest plot of comparison 2: Intervention vs. placeboOutcome 2.2: Physical activity: change in step count (steps per day)
Figuras y tablas -
Figure 13

Forest plot of comparison 2: Intervention vs. placebo

Outcome 2.2: Physical activity: change in step count (steps per day)

Forest plot of comparison 2: Intervention vs. placeboOutcome 2.3: Physical activity: change in time in moderate‐to‐vigorous intensity physical activity (minutes per day)
Figuras y tablas -
Figure 14

Forest plot of comparison 2: Intervention vs. placebo

Outcome 2.3: Physical activity: change in time in moderate‐to‐vigorous intensity physical activity (minutes per day)

Forest plot of comparison 2: Intervention vs. placeboOutcome 2.4: Physical activity: change in active energy expenditure (kcal)
Figuras y tablas -
Figure 15

Forest plot of comparison 2: Intervention vs. placebo

Outcome 2.4: Physical activity: change in active energy expenditure (kcal)

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 1 change in step count (steps per day); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 1.1

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 1 change in step count (steps per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 2 time/change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 1.2

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 2 time/change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 3 change in time in light‐intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 1.3

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 3 change in time in light‐intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 4 change in total energy expenditure (kcal); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 1.4

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 4 change in total energy expenditure (kcal); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 5 change in time in physical activity (total; minutes per day); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 1.5

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 5 change in time in physical activity (total; minutes per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 6 change in sedentary time (minutes per day); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 1.6

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 6 change in sedentary time (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 7 time in "lifestyle" physical activity (minutes per day); Intervention: high‐intensity interval training.
Figuras y tablas -
Analysis 1.7

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 7 time in "lifestyle" physical activity (minutes per day); Intervention: high‐intensity interval training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 8 time in light‐intensity physical activity (minutes per day); Intervention: high‐intensity interval training.
Figuras y tablas -
Analysis 1.8

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 8 time in light‐intensity physical activity (minutes per day); Intervention: high‐intensity interval training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 9 time in moderate‐to‐vigorous intensity physical activity (minutes per day); Intervention: high‐intensity interval training.
Figuras y tablas -
Analysis 1.9

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 9 time in moderate‐to‐vigorous intensity physical activity (minutes per day); Intervention: high‐intensity interval training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 10 sedentary time (minutes per day); Intervention: high‐intensity interval training.
Figuras y tablas -
Analysis 1.10

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 10 sedentary time (minutes per day); Intervention: high‐intensity interval training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 11 step count (steps per day); Intervention: physical activity counselling.
Figuras y tablas -
Analysis 1.11

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 11 step count (steps per day); Intervention: physical activity counselling.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 12 "IMA" (counts per minute); Intervention: self‐management.
Figuras y tablas -
Analysis 1.12

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 12 "IMA" (counts per minute); Intervention: self‐management.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 13 physical activity level; Intervention: nutritional supplement.
Figuras y tablas -
Analysis 1.13

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 13 physical activity level; Intervention: nutritional supplement.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 14 total energy expenditure (MJ); Intervention: nutritional supplement.
Figuras y tablas -
Analysis 1.14

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 14 total energy expenditure (MJ); Intervention: nutritional supplement.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 15 subgroup analysis (supervised vs. unsupervised); change in step count (steps per day); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 1.15

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 15 subgroup analysis (supervised vs. unsupervised); change in step count (steps per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 16 supgroup analysis (supervised vs. unsupervised); change in time in light‐intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 1.16

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 16 supgroup analysis (supervised vs. unsupervised); change in time in light‐intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 17 subgroup analysis (supervised vs. unsupervised); change in total energy expenditure (kcal); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 1.17

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 17 subgroup analysis (supervised vs. unsupervised); change in total energy expenditure (kcal); Intervention: pulmonary rehabilitation/exercise training.

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 18 subgroup analysis (supervised vs. unsupervised); change in sedentary time (minutes per day); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 1.18

Comparison 1 Physical activity: intervention vs. no intervention, Outcome 18 subgroup analysis (supervised vs. unsupervised); change in sedentary time (minutes per day); Intervention: pulmonary rehabilitation/exercise training.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 1 step count (steps per day); Intervention: self‐management (health mentoring).
Figuras y tablas -
Analysis 2.1

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 1 step count (steps per day); Intervention: self‐management (health mentoring).

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 2 change in step count (steps per day); Intervention: LAMA/LABA.
Figuras y tablas -
Analysis 2.2

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 2 change in step count (steps per day); Intervention: LAMA/LABA.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 3 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day): Intervention: LAMA/LABA.
Figuras y tablas -
Analysis 2.3

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 3 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day): Intervention: LAMA/LABA.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 4 change in active energy expenditure (kcal); Intervention: LAMA/LABA.
Figuras y tablas -
Analysis 2.4

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 4 change in active energy expenditure (kcal); Intervention: LAMA/LABA.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 5 step count (steps per day); Intervention: nutritional supplement.
Figuras y tablas -
Analysis 2.5

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 5 step count (steps per day); Intervention: nutritional supplement.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 6 energy expenditure for ambulation (kcal/step/FFM kg); Intervention: nutritional supplement.
Figuras y tablas -
Analysis 2.6

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 6 energy expenditure for ambulation (kcal/step/FFM kg); Intervention: nutritional supplement.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 7 change in step count (steps per day); Intervention: neuromuscular electrical stimulation.
Figuras y tablas -
Analysis 2.7

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 7 change in step count (steps per day); Intervention: neuromuscular electrical stimulation.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 8 change in up/down transitions (number); Intervention: neuromuscular electrical stimulation.
Figuras y tablas -
Analysis 2.8

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 8 change in up/down transitions (number); Intervention: neuromuscular electrical stimulation.

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 9 change in time upright (hours); Intervention: neuromuscular electrical stimulation.
Figuras y tablas -
Analysis 2.9

Comparison 2 Physical activity: intervention vs. placebo/sham, Outcome 9 change in time upright (hours); Intervention: neuromuscular electrical stimulation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 1 movement intensity (m/s2); Interventions: nordic walking with education vs. education.
Figuras y tablas -
Analysis 3.1

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 1 movement intensity (m/s2); Interventions: nordic walking with education vs. education.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 2 change in step count (steps per day); Interventions: exercise training (COPE‐active) with self‐management vs. self management.
Figuras y tablas -
Analysis 3.2

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 2 change in step count (steps per day); Interventions: exercise training (COPE‐active) with self‐management vs. self management.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 3 change in time in light‐intensity physical activity (minutes per day); Interventions: upper body resistance training with health education vs. health education.
Figuras y tablas -
Analysis 3.3

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 3 change in time in light‐intensity physical activity (minutes per day); Interventions: upper body resistance training with health education vs. health education.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 4 step count (steps per day); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 3.4

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 4 step count (steps per day); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 5 time walking (minutes per day); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 3.5

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 5 time walking (minutes per day); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 6 walking intensity (m/s2); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 3.6

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 6 walking intensity (m/s2); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 7 step count (steps per day); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.
Figuras y tablas -
Analysis 3.7

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 7 step count (steps per day); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 8 time walking (minutes per day); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.
Figuras y tablas -
Analysis 3.8

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 8 time walking (minutes per day); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 9 walking intensity (m/s2); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.
Figuras y tablas -
Analysis 3.9

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 9 walking intensity (m/s2); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 10 step count (steps per day); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.
Figuras y tablas -
Analysis 3.10

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 10 step count (steps per day); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 11 time walking (minutes per day); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.
Figuras y tablas -
Analysis 3.11

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 11 time walking (minutes per day); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 12 walking intensity (m/s2); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.
Figuras y tablas -
Analysis 3.12

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 12 walking intensity (m/s2); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 13 change in step count (steps per day); Interventions: exercise training and physical activity counselling with pedometer vs. pedometer.
Figuras y tablas -
Analysis 3.13

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 13 change in step count (steps per day); Interventions: exercise training and physical activity counselling with pedometer vs. pedometer.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 14 change in step count (weekday, steps per day); Interventions: physical activity counselling with optional supervised exercise vs. optional supervised exercise.
Figuras y tablas -
Analysis 3.14

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 14 change in step count (weekday, steps per day); Interventions: physical activity counselling with optional supervised exercise vs. optional supervised exercise.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 15 METs; Interventions: physical activity counselling with optional supervised exercise vs. optional supervised exercise.
Figuras y tablas -
Analysis 3.15

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 15 METs; Interventions: physical activity counselling with optional supervised exercise vs. optional supervised exercise.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 16 step count (steps per day); Interventions: physical activity counselling with pedometer vs. pedometer.
Figuras y tablas -
Analysis 3.16

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 16 step count (steps per day); Interventions: physical activity counselling with pedometer vs. pedometer.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 17 time active (minutes per day); Interventions: physical activity counselling (app) with pedometer vs. pedometer.
Figuras y tablas -
Analysis 3.17

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 17 time active (minutes per day); Interventions: physical activity counselling (app) with pedometer vs. pedometer.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 18 time inactive (minutes per day); Interventions: physical activity counselling (app) with pedometer vs. pedometer.
Figuras y tablas -
Analysis 3.18

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 18 time inactive (minutes per day); Interventions: physical activity counselling (app) with pedometer vs. pedometer.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 19 peak performance (steps per minute); Interventions: physical activity counselling (app) with pedometer vs. pedometer.
Figuras y tablas -
Analysis 3.19

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 19 peak performance (steps per minute); Interventions: physical activity counselling (app) with pedometer vs. pedometer.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 20 step count (steps per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.20

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 20 step count (steps per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 21 time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.21

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 21 time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 22 time in physical activity (total, minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.22

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 22 time in physical activity (total, minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 23 time sedentary (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.23

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 23 time sedentary (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 24 change in step count (steps per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.24

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 24 change in step count (steps per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 25 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.25

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 25 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 26 change in time walking (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.26

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 26 change in time walking (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 27 change in time in physical activity (total, minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.27

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 27 change in time in physical activity (total, minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 28 change in time in light‐intensity physical activity (minutes per day); Interventions: exercise‐specific self‐efficacy training with upper body resistance training vs. upper body resistance training.
Figuras y tablas -
Analysis 3.28

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 28 change in time in light‐intensity physical activity (minutes per day); Interventions: exercise‐specific self‐efficacy training with upper body resistance training vs. upper body resistance training.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 29 step count (steps per day); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 3.29

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 29 step count (steps per day); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 30 time walking (minutes per day); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 3.30

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 30 time walking (minutes per day); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 31 walking intensity (m/s2); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 3.31

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 31 walking intensity (m/s2); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 32 step count (steps per day); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 3.32

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 32 step count (steps per day); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 33 time walking (minutes per day); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 3.33

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 33 time walking (minutes per day); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 34 walking intensity (m/s2); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 3.34

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 34 walking intensity (m/s2); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 35 step count (steps per day); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.
Figuras y tablas -
Analysis 3.35

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 35 step count (steps per day); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 36 time walking (minutes per day); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.
Figuras y tablas -
Analysis 3.36

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 36 time walking (minutes per day); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 37 walking intensity (m/s2); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.
Figuras y tablas -
Analysis 3.37

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 37 walking intensity (m/s2); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 38 change in step count (steps per day); Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.38

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 38 change in step count (steps per day); Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 39 change in step count (steps per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.39

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 39 change in step count (steps per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 40 change in time in moderate‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.40

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 40 change in time in moderate‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 41 change in time in vigorous‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.41

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 41 change in time in vigorous‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 42 change in time in light‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.42

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 42 change in time in light‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 43 change in total energy expenditure (kcal); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.43

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 43 change in total energy expenditure (kcal); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 44 change in sedentary time (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.
Figuras y tablas -
Analysis 3.44

Comparison 3 Physical activity: intervention with common intervention vs. common intervention, Outcome 44 change in sedentary time (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 1 change in step count (steps per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.
Figuras y tablas -
Analysis 4.1

Comparison 4 Physical activity: intervention vs. intervention, Outcome 1 change in step count (steps per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 2 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.
Figuras y tablas -
Analysis 4.2

Comparison 4 Physical activity: intervention vs. intervention, Outcome 2 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 3 change in number of bouts of moderate‐to‐vigorous intensity physical activity; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.
Figuras y tablas -
Analysis 4.3

Comparison 4 Physical activity: intervention vs. intervention, Outcome 3 change in number of bouts of moderate‐to‐vigorous intensity physical activity; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 4 change in time in bouts of moderate‐to‐vigorous intensity physical activity(minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.
Figuras y tablas -
Analysis 4.4

Comparison 4 Physical activity: intervention vs. intervention, Outcome 4 change in time in bouts of moderate‐to‐vigorous intensity physical activity(minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 5 change in sedentary time (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.
Figuras y tablas -
Analysis 4.5

Comparison 4 Physical activity: intervention vs. intervention, Outcome 5 change in sedentary time (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 6 change in sedentary time (awake; minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.
Figuras y tablas -
Analysis 4.6

Comparison 4 Physical activity: intervention vs. intervention, Outcome 6 change in sedentary time (awake; minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 7 change in number of sedentary bouts; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.
Figuras y tablas -
Analysis 4.7

Comparison 4 Physical activity: intervention vs. intervention, Outcome 7 change in number of sedentary bouts; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 8 change in time in sedentary bouts (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.
Figuras y tablas -
Analysis 4.8

Comparison 4 Physical activity: intervention vs. intervention, Outcome 8 change in time in sedentary bouts (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 9 change in METs; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.
Figuras y tablas -
Analysis 4.9

Comparison 4 Physical activity: intervention vs. intervention, Outcome 9 change in METs; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 10 change in total energy expenditure (kcal); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.
Figuras y tablas -
Analysis 4.10

Comparison 4 Physical activity: intervention vs. intervention, Outcome 10 change in total energy expenditure (kcal); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 11 change in step count (steps per day); Interventions: water‐based exercise training vs. land‐based exercise training.
Figuras y tablas -
Analysis 4.11

Comparison 4 Physical activity: intervention vs. intervention, Outcome 11 change in step count (steps per day); Interventions: water‐based exercise training vs. land‐based exercise training.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 12 change in total energy expenditure (kcal); Interventions: water‐based exercise training vs. land‐based exercise training.
Figuras y tablas -
Analysis 4.12

Comparison 4 Physical activity: intervention vs. intervention, Outcome 12 change in total energy expenditure (kcal); Interventions: water‐based exercise training vs. land‐based exercise training.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 13 step count (steps per day); Interventions: Tai Chi vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 4.13

Comparison 4 Physical activity: intervention vs. intervention, Outcome 13 step count (steps per day); Interventions: Tai Chi vs. pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 14 step count (steps per day); Interventions: outdoor walking vs. cycle ergometry.
Figuras y tablas -
Analysis 4.14

Comparison 4 Physical activity: intervention vs. intervention, Outcome 14 step count (steps per day); Interventions: outdoor walking vs. cycle ergometry.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 15 step count (steps per day); Interventions: physical activity counselling vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 4.15

Comparison 4 Physical activity: intervention vs. intervention, Outcome 15 step count (steps per day); Interventions: physical activity counselling vs. pulmonary rehabilitation.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 16 total energy expenditure (kcal); Interventions: exercise training with tapered supervision vs. supervised exercise training.
Figuras y tablas -
Analysis 4.16

Comparison 4 Physical activity: intervention vs. intervention, Outcome 16 total energy expenditure (kcal); Interventions: exercise training with tapered supervision vs. supervised exercise training.

Comparison 4 Physical activity: intervention vs. intervention, Outcome 17 mid day activity (vector magnitude units per minute); Interventions: supplemental oxygen (lightweight ambulatory) vs. supplemental oxygen (E‐cylinder).
Figuras y tablas -
Analysis 4.17

Comparison 4 Physical activity: intervention vs. intervention, Outcome 17 mid day activity (vector magnitude units per minute); Interventions: supplemental oxygen (lightweight ambulatory) vs. supplemental oxygen (E‐cylinder).

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 1 change in SGRQ total score; Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 5.1

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 1 change in SGRQ total score; Intervention: pulmonary rehabilitation/exercise training.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 2 change in SGRQ domain scores. Intervention: pulmonary rehabilitation/exercise training (ground‐based walking).
Figuras y tablas -
Analysis 5.2

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 2 change in SGRQ domain scores. Intervention: pulmonary rehabilitation/exercise training (ground‐based walking).

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 3 change in CRQ domain scores; Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 5.3

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 3 change in CRQ domain scores; Intervention: pulmonary rehabilitation/exercise training.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 4 CAT score; Intervention: high‐intensity interval training.
Figuras y tablas -
Analysis 5.4

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 4 CAT score; Intervention: high‐intensity interval training.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 5 SGRQ domain scores (%change); Intervention: exercise training [inpatient].
Figuras y tablas -
Analysis 5.5

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 5 SGRQ domain scores (%change); Intervention: exercise training [inpatient].

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 6 SGRQ domain scores; Intervention: physical activity counselling.
Figuras y tablas -
Analysis 5.6

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 6 SGRQ domain scores; Intervention: physical activity counselling.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 7 CCQ domain scores: Intervention: physical activity counselling.
Figuras y tablas -
Analysis 5.7

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 7 CCQ domain scores: Intervention: physical activity counselling.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 8 change in CCQ domain scores; Intervention: physical activity counselling (telecoaching).
Figuras y tablas -
Analysis 5.8

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 8 change in CCQ domain scores; Intervention: physical activity counselling (telecoaching).

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 9 change in CRQ domain and total scores; Intervention: physical activity counselling.
Figuras y tablas -
Analysis 5.9

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 9 change in CRQ domain and total scores; Intervention: physical activity counselling.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 10 change in SGRQ domain and total scores; Intervention: physical activity counselling.
Figuras y tablas -
Analysis 5.10

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 10 change in SGRQ domain and total scores; Intervention: physical activity counselling.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 11 change in CRQ domain scores; Intervention: self‐management (SPACE).
Figuras y tablas -
Analysis 5.11

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 11 change in CRQ domain scores; Intervention: self‐management (SPACE).

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 12 CCQ total score; Intervention: self‐management.
Figuras y tablas -
Analysis 5.12

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 12 CCQ total score; Intervention: self‐management.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 13 EQ5D index score; Intervention: self‐management.
Figuras y tablas -
Analysis 5.13

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 13 EQ5D index score; Intervention: self‐management.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 14 EQ5D visual analogue scale score; Intervention: self‐management.
Figuras y tablas -
Analysis 5.14

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 14 EQ5D visual analogue scale score; Intervention: self‐management.

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 15 SGRQ domain scores; Intervention: self‐management (telephone health coaching).
Figuras y tablas -
Analysis 5.15

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 15 SGRQ domain scores; Intervention: self‐management (telephone health coaching).

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 16 EQ5D score; Intervention: self‐management (telephone health coaching).
Figuras y tablas -
Analysis 5.16

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 16 EQ5D score; Intervention: self‐management (telephone health coaching).

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 17 CRQ domain scores; Intervention: four‐wheeled walker.
Figuras y tablas -
Analysis 5.17

Comparison 5 Health‐related quality of life: intervention vs. no intervention, Outcome 17 CRQ domain scores; Intervention: four‐wheeled walker.

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 1 change in SF36 component scores; Intervention: singing.
Figuras y tablas -
Analysis 6.1

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 1 change in SF36 component scores; Intervention: singing.

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 2 change in CRQ total score; Intervention: neuromuscular electrical stimulation.
Figuras y tablas -
Analysis 6.2

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 2 change in CRQ total score; Intervention: neuromuscular electrical stimulation.

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 3 change in SGRQ total score; Intervention: neuromuscular electrical stimulation.
Figuras y tablas -
Analysis 6.3

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 3 change in SGRQ total score; Intervention: neuromuscular electrical stimulation.

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 4 change in EQ5D index score; Intervention: neuromuscular electrical stimulation.
Figuras y tablas -
Analysis 6.4

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 4 change in EQ5D index score; Intervention: neuromuscular electrical stimulation.

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 5 change in EQ5D visual analogue scale score; Intervention: neuromuscular electrical stimulation.
Figuras y tablas -
Analysis 6.5

Comparison 6 Health‐related quality of life: intervention vs. placebo/sham, Outcome 5 change in EQ5D visual analogue scale score; Intervention: neuromuscular electrical stimulation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 1 SF36 component scores (score < 50); Interventions: Nordic walking with education vs. education.
Figuras y tablas -
Analysis 7.1

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 1 SF36 component scores (score < 50); Interventions: Nordic walking with education vs. education.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 2 change in CRQ domain scores; Interventions: exercise training (COPE‐active) with self‐management vs. self management.
Figuras y tablas -
Analysis 7.2

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 2 change in CRQ domain scores; Interventions: exercise training (COPE‐active) with self‐management vs. self management.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 3 change in CCQ domain scores; Interventions: exercise training (COPE‐active) with self‐management vs. self management.
Figuras y tablas -
Analysis 7.3

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 3 change in CCQ domain scores; Interventions: exercise training (COPE‐active) with self‐management vs. self management.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 4 CRQ domain scores; Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 7.4

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 4 CRQ domain scores; Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 5 CRQ domain scores; Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.
Figuras y tablas -
Analysis 7.5

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 5 CRQ domain scores; Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 6 CRQ domain scores; Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.
Figuras y tablas -
Analysis 7.6

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 6 CRQ domain scores; Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 7 change in SGRQ domain and total scores; Intervention: exercise training and physical activity counselling with pedometer vs. pedometer.
Figuras y tablas -
Analysis 7.7

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 7 change in SGRQ domain and total scores; Intervention: exercise training and physical activity counselling with pedometer vs. pedometer.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 8 change in CRQ domain scores; Interventions: physical activity counselling (app) with optional supervised exercise vs. optional supervised exercise.
Figuras y tablas -
Analysis 7.8

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 8 change in CRQ domain scores; Interventions: physical activity counselling (app) with optional supervised exercise vs. optional supervised exercise.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 9 change in SGRQ total score; Interventions: physical activity counselling with pedometer vs. pedometer.
Figuras y tablas -
Analysis 7.9

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 9 change in SGRQ total score; Interventions: physical activity counselling with pedometer vs. pedometer.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 10 SGRQ total: Interventions: physical activity counselling (app) with pedometer vs. pedometer.
Figuras y tablas -
Analysis 7.10

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 10 SGRQ total: Interventions: physical activity counselling (app) with pedometer vs. pedometer.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 11 SF36: Interventions: physical activity counselling (app) with pedometer vs. pedometer.
Figuras y tablas -
Analysis 7.11

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 11 SF36: Interventions: physical activity counselling (app) with pedometer vs. pedometer.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 12 change in SGRQ domain scores; Interventions: physical activity counselling (web‐based) with pedometer vs. pedometer.
Figuras y tablas -
Analysis 7.12

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 12 change in SGRQ domain scores; Interventions: physical activity counselling (web‐based) with pedometer vs. pedometer.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 13 SGRQ domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 7.13

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 13 SGRQ domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 14 RAND36 domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 7.14

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 14 RAND36 domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 15 change in CRQ dyspnoea domain score; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 7.15

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 15 change in CRQ dyspnoea domain score; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 16 SGRQ scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 7.16

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 16 SGRQ scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 17 CRQ domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 7.17

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 17 CRQ domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 18 change in CRQ total score; Interventions: physical activity counselling with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.
Figuras y tablas -
Analysis 7.18

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 18 change in CRQ total score; Interventions: physical activity counselling with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 19 change in CRQ scores; Interventions: self‐management (health coaching) with pulmonary rehabilitation referral vs. pulmonary rehabilitation referral.
Figuras y tablas -
Analysis 7.19

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 19 change in CRQ scores; Interventions: self‐management (health coaching) with pulmonary rehabilitation referral vs. pulmonary rehabilitation referral.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 20 CRQ domain scores; Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 7.20

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 20 CRQ domain scores; Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 21 CRQ domain scores; Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 7.21

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 21 CRQ domain scores; Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 22 CRQ domain scores; Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.
Figuras y tablas -
Analysis 7.22

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 22 CRQ domain scores; Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 23 change in SGRQ domain and total scores; Interventions: ACE inhibitor with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.
Figuras y tablas -
Analysis 7.23

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 23 change in SGRQ domain and total scores; Interventions: ACE inhibitor with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 24 change in SGRQ total score; Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.
Figuras y tablas -
Analysis 7.24

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 24 change in SGRQ total score; Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 25 change in EQ5D; Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.
Figuras y tablas -
Analysis 7.25

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 25 change in EQ5D; Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 26 change in CRQ domain scores; Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.
Figuras y tablas -
Analysis 7.26

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 26 change in CRQ domain scores; Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 27 CRQ domain scores; Interventions: non‐invasive ventilation with pulmonary rehabilitation vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 7.27

Comparison 7 Health‐related quality of life: intervention with common intervention vs. common intervention, Outcome 27 CRQ domain scores; Interventions: non‐invasive ventilation with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 8 Exercise capacity: intervention vs. placebo/sham, Outcome 1 change in 6MWD (metres); Intervention; neuromuscular electrical stimulation.
Figuras y tablas -
Analysis 8.1

Comparison 8 Exercise capacity: intervention vs. placebo/sham, Outcome 1 change in 6MWD (metres); Intervention; neuromuscular electrical stimulation.

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 1 change in 6MWD (metres); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 9.1

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 1 change in 6MWD (metres); Intervention: pulmonary rehabilitation/exercise training.

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 2 change in ISWD (metres); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 9.2

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 2 change in ISWD (metres); Intervention: pulmonary rehabilitation/exercise training.

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 3 change in ESWT (seconds); Intervention: pulmonary rehabilitation/exercise training.
Figuras y tablas -
Analysis 9.3

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 3 change in ESWT (seconds); Intervention: pulmonary rehabilitation/exercise training.

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 4 6MWD (metres); Intervention: high‐intensity interval training.
Figuras y tablas -
Analysis 9.4

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 4 6MWD (metres); Intervention: high‐intensity interval training.

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 5 work rate (watts); Intervention: high‐intensity interval training.
Figuras y tablas -
Analysis 9.5

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 5 work rate (watts); Intervention: high‐intensity interval training.

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 6 change in ISWD (metres); Intervention: self‐management (SPACE).
Figuras y tablas -
Analysis 9.6

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 6 change in ISWD (metres); Intervention: self‐management (SPACE).

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 7 change in ESWT (seconds); Intervention: self‐management (SPACE).
Figuras y tablas -
Analysis 9.7

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 7 change in ESWT (seconds); Intervention: self‐management (SPACE).

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 8 6MWD (metres); Intervention: exercise training [inpatient].
Figuras y tablas -
Analysis 9.8

Comparison 9 Exercise capacity: intervention vs. no intervention, Outcome 8 6MWD (metres); Intervention: exercise training [inpatient].

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 1 change in CRQ domains; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.
Figuras y tablas -
Analysis 10.1

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 1 change in CRQ domains; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 2 change in CRQ domains; Interventions: water‐based exercise training vs. land‐based exercise training.
Figuras y tablas -
Analysis 10.2

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 2 change in CRQ domains; Interventions: water‐based exercise training vs. land‐based exercise training.

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 3 SGRQ domain and total scores; Interventions: Tai Chi vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 10.3

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 3 SGRQ domain and total scores; Interventions: Tai Chi vs. pulmonary rehabilitation.

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 4 CRQ total score; Interventions: outdoor walking vs. cycle ergometry.
Figuras y tablas -
Analysis 10.4

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 4 CRQ total score; Interventions: outdoor walking vs. cycle ergometry.

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 5 Maugeri Respiratory Failure questionnaire; Interventions: exercise training with tapered supervision vs. supervised exercise training.
Figuras y tablas -
Analysis 10.5

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 5 Maugeri Respiratory Failure questionnaire; Interventions: exercise training with tapered supervision vs. supervised exercise training.

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 6 SF36 domain scores; Interventions: self‐management vs. education and symptom monitoring.
Figuras y tablas -
Analysis 10.6

Comparison 10 Health‐related quality of life: intervention vs. intervention, Outcome 6 SF36 domain scores; Interventions: self‐management vs. education and symptom monitoring.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 1 6MWD (metres); Interventions: Nordic walking with education vs. education.
Figuras y tablas -
Analysis 11.1

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 1 6MWD (metres); Interventions: Nordic walking with education vs. education.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 2 change in ISWD (metres); Interventions: exercise training (COPE‐active) with self‐management vs. self management.
Figuras y tablas -
Analysis 11.2

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 2 change in ISWD (metres); Interventions: exercise training (COPE‐active) with self‐management vs. self management.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 3 change in ESWT (seconds); Interventions: exercise training (COPE‐active) with self‐management vs. self management.
Figuras y tablas -
Analysis 11.3

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 3 change in ESWT (seconds); Interventions: exercise training (COPE‐active) with self‐management vs. self management.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 4 6MWD (metres); Interventions: exercise training and LAMA/LABA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 11.4

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 4 6MWD (metres); Interventions: exercise training and LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 5 ESWT (seconds); Interventions: exercise training and LAMA/LABA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 11.5

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 5 ESWT (seconds); Interventions: exercise training and LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 6 6MWD (metres); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.
Figuras y tablas -
Analysis 11.6

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 6 6MWD (metres); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 7 ESWT (seconds); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.
Figuras y tablas -
Analysis 11.7

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 7 ESWT (seconds); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 8 6MWD (metres); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.
Figuras y tablas -
Analysis 11.8

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 8 6MWD (metres); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 9 ESWT (seconds); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.
Figuras y tablas -
Analysis 11.9

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 9 ESWT (seconds); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 10 change in ESWT (seconds); Intervention: physical activity counselling and exercise training with pedometer vs. pedometer.
Figuras y tablas -
Analysis 11.10

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 10 change in ESWT (seconds); Intervention: physical activity counselling and exercise training with pedometer vs. pedometer.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 11 6MWD (metres); Interventions: physical activity counselling (app) with optional supervised exercise vs. optional supervised exercise.
Figuras y tablas -
Analysis 11.11

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 11 6MWD (metres); Interventions: physical activity counselling (app) with optional supervised exercise vs. optional supervised exercise.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 12 6MWD (metres); Interventions: physical activity counselling (app) with pedometer vs. pedometer.
Figuras y tablas -
Analysis 11.12

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 12 6MWD (metres); Interventions: physical activity counselling (app) with pedometer vs. pedometer.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 13 6MWD (metres); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 11.13

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 13 6MWD (metres); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 14 change in 6MWD (metres); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.
Figuras y tablas -
Analysis 11.14

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 14 change in 6MWD (metres); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 15 6MWD (metres); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 11.15

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 15 6MWD (metres); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 16 ESWT (seconds); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 11.16

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 16 ESWT (seconds); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 17 6MWD (metres); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 11.17

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 17 6MWD (metres); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 18 ESWT (s); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.
Figuras y tablas -
Analysis 11.18

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 18 ESWT (s); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 19 6MWD (metres); Interventions: LAMA/LABA with behaviour modification vs. LAMA with behaviour modification.
Figuras y tablas -
Analysis 11.19

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 19 6MWD (metres); Interventions: LAMA/LABA with behaviour modification vs. LAMA with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 20 ESWT (seconds); Interventions: LAMA/LABA with behaviour modification vs. LAMA with behaviour modification.
Figuras y tablas -
Analysis 11.20

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 20 ESWT (seconds); Interventions: LAMA/LABA with behaviour modification vs. LAMA with behaviour modification.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 21 change in ISWD (metres); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.
Figuras y tablas -
Analysis 11.21

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 21 change in ISWD (metres); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 22 change in ESWT (seconds); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.
Figuras y tablas -
Analysis 11.22

Comparison 11 Exercise capacity: intervention with common intervention vs. common intervention, Outcome 22 change in ESWT (seconds); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation.

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 1 change in 6MWD (metres); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.
Figuras y tablas -
Analysis 12.1

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 1 change in 6MWD (metres); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation.

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 2 change in 6MWD (metres); Interventions: water‐based exercise training vs. land‐based exercise training.
Figuras y tablas -
Analysis 12.2

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 2 change in 6MWD (metres); Interventions: water‐based exercise training vs. land‐based exercise training.

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 3 change in ISWD (metres); Interventions: water‐based exercise training vs. land‐based exercise training.
Figuras y tablas -
Analysis 12.3

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 3 change in ISWD (metres); Interventions: water‐based exercise training vs. land‐based exercise training.

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 4 change in VO2max (ml/min); Interventions: water‐based exercise training vs. land‐based exercise training.
Figuras y tablas -
Analysis 12.4

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 4 change in VO2max (ml/min); Interventions: water‐based exercise training vs. land‐based exercise training.

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 5 6MWD (metres); Interventions: Tai Chi vs. pulmonary rehabilitation.
Figuras y tablas -
Analysis 12.5

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 5 6MWD (metres); Interventions: Tai Chi vs. pulmonary rehabilitation.

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 6 6MWD (metres); Interventions: exercise training with tapered supervision vs. supervised exercise training.
Figuras y tablas -
Analysis 12.6

Comparison 12 Exercise capacity: intervention vs. intervention, Outcome 6 6MWD (metres); Interventions: exercise training with tapered supervision vs. supervised exercise training.

Summary of findings for the main comparison. Pulmonary rehabilitation/exercise training versus no intervention

Population: people with COPD, clinical stability

Intervention: pulmonary rehabilitation/exercise training

Comparisons: intervention versus no intervention

Outcome: time in physical activity (of at least moderate intensity) at end intervention

Interventions

Outcome

Illustrative comparative risks* [mean difference (95% CI) unless indicated]

Number of participants (studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

No intervention

Pulmonary rehabilitation/exercise training

Pulmonary rehabilitation vs. no intervention

(8 to 10 weeks)

Time/change in time in MVPA

The mean change in time ranged from −1 to 6 minutes per day, mean time 27 minutes per day

The mean difference was 4 (−2 to 9) minutes per day

190 participants (3 studies; Analysis 1.2)

⊕⊕⊝⊝
lowa

Baseline values:

De Roos 2017 no intervention mean 11 (SD 10), pulmonary rehabilitation 12 (11);

Wootton 2017 no intervention 46 (39), pulmonary rehabilitation 54 (43)

High‐intensity interval training vs. no intervention

(8 to 12 weeks)

Time in MVPA

The mean time ranged from 12 to 14 minutes per day

The mean difference was 6 (4 to 8) minutes per day

275 participants (2 studies; Analysis 1.9)

⊕⊕⊕⊝

moderateb

Maintenance (telerehabilitation) following high‐intensity interval training vs. no intervention

(12 months)

Time in moderate intensity physical activity

The mean time was 11 minutes per day

The mean difference was 7 (4 to 10) minutes per day

97 participants (1 study; Vasilopoulou 2017; Table 1)

⊕⊕⊕⊝

moderateb

Maintenance (centre‐based) following high intensity interval training vs. no intervention

(12 months)

The mean difference was 11 (8 to 14) minutes per day

100 participants (1 study; Vasilopoulou 2017; Table 1)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MVPA: moderate‐to‐vigorous physical activity; SD: standard deviation

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

aDowngraded one level for high risk of performance bias. Downgraded one level for imprecision as CI does not exclude possibility of no effect.
bDowngraded one level for high risk of performance bias.

Figuras y tablas -
Summary of findings for the main comparison. Pulmonary rehabilitation/exercise training versus no intervention
Table 1. Physical activity outcomes

Study

Comparison (setting, if known)

Clinical stability unless indicated

Timepoint (end intervention unless indicated)

Outcome (minutes unless indicated)

Intervention group

Comparison group

Between‐group MD (95% CI) where available unless indicated

n

mean (95% CI) unless indicated

n

mean (95% CI) unless indicated

Altenburg 2015

Physical activity counselling vs. no intervention (primary care)

12 weeks

∆ step count (n)

22

median 537 (IQR −611 to 1740)

18

median 431 (IQR −899 to 749)

P = 0.48*

∆ "daily physical activity" (n)

median 1408 (IQR −2165 to 3304)

median 528 (IQR −966 to 2179)

P = 0.35*

follow‐up (12 months post‐intervention)

∆ step count (n)

20

median 157 (IQR −1679 to 994)

18

median 48 (IQR −1004 to 885)

P = 0.90*

∆ "daily physical activity" (n)

median 353 (IQR −1518 to 3038)

median −576 (IQR −2517 to 1008)

P = 0.26*

Physical activity counselling vs. no intervention (secondary care)

12 weeks

∆ step count (n)

21

median 1002 (IQR −612 to 3077)

22

median −814 (IQR −2827 to 1063)

P = 0.007*

∆ "daily physical activity" (n)

median 1575 (IQR −752 to 3864)

median −1041 (IQR −1971 to 1031)

P = 0.007*

follow‐up (12 months post‐intervention)

∆ step count (n)

20

median 1128 (IQR −1322 to 2707)

19

median −217 (IQR −1951 to 1147)

P = 0.15*

∆ "daily physical activity" (n)

median 1798 (IQR −1994 to 3128)

median −718 (IQR −1812 to 512)

P = 0.11*

Physical activity counselling with PR vs. PR

12 weeks

∆ step count (n)

22

median 547 (IQR 187 to 1323)

15

median −211 (IQR −1337 to 1038)

P = 0.03*

∆ "daily physical activity" (n)

median 1302 (IQR −173 to 1922)

median −849 (IQR −2223 to 961)

P = 0.03*

follow‐up (12 months post‐intervention)

∆ step count (n)

10

median −569 (IQR −2512 to 1551)

13

median −1137 (IQR −2376 to 1427)

P = 0.58*

∆ "daily physical activity" (n)

median −213 (IQR −4525 to 2274)

median −1827 (IQR −3540 to 629)

P = 0.97*

Physical activity counselling vs. no intervention (primary care)

SUBGROUP: ≥ 10,000 steps per day (baseline)

12 weeks

∆ step count (n)

median 675 (IQR 4 to 1853)

median 342 (IQR −955 to 658)

P = 0.20*

∆ "daily physical activity" (n)

median 1807 (IQR 164 to 3720)

median 519 (IQR −1089 to 1709]

P = 0.11*

follow‐up (12 months post‐intervention)

∆ step count (n)

median 201 (IQR −693 to 1170)

median 38 (IQR −1071 to 821)

P = 0.55*

∆ "daily physical activity" (n)

median 525 (IQR −545 to 3078)

median −726 (IQR −2954 to 711)

P = 0.06*

Physical activity counselling vs. no intervention (secondary care)

SUBGROUP: ≤ 10,000 steps per day (baseline)

12 weeks

∆ step count (n)

median 1289 (IQR −183 to 3107)

median 34 (IQR −1707 to 1095)

P = 0.02*

∆ "daily physical activity" (n)

median 1763 (IQR −763 to 3913)

median −925 (IQR −1452 to 1052)

P = 0.03*

follow‐up (12 months post‐intervention)

∆ step count (n)

median 1436 (IQR −1492 to 2722)

median 0 (IQR −1825 to 1103)

P = 0.12*

∆ "daily physical activity" (n)

median 1928 (IQR −1140 to 3320)

median −526 (IQR −1657 to 435)

P = 0.078*

Physical activity counselling with PR vs. PR

SUBGROUP: ≤ 10,000 steps per day (baseline)

12 weeks

∆ step count (n)

median 547 (IQR 187 to 1323)

median −198 (IQR −1403 to 1051)

P = 0.04*

∆ "daily physical activity" (n)

median 1302 (IQR −173 to 1922)

median −843 (IQR −1737 to 1329)

P = 0.052*

follow‐up (12 months post intervention)

∆ step count (n)

median −569 (IQR −1770 to 2170)

median −759 (IQR −2027 to 1641)

P = 0.78*

∆ "daily physical activity" (n)

median −213 (IQR −4525 to 2274)

median −644 (IQR −3706 to 844)

P = 0.91*

Beeh 2014

LAMA vs. placebo

3 weeks

∆ step count (n)

51

median 69 (IQR −834 to 1262)

53

median 125 (IQR −1180 to 1249)

P = 0.73

∆ MVPA time

median 1 (IQR −22 to 25)

median −6 (IQR −21 to 15)

P = 0.11

∆ PAL

median 0.00 (IQR −0.08 to 0.09)

median −0.01 (IQR −0.09 to 0.09)

P = 0.95

∆ active EE (kcal)

median 10 (−131 to 116)

median −44 (IQR −122 to 40)

P = 0.11

Bender 2016

Physical activity counselling with pedometer vs. pedometer

12 weeks

step count (n)

49

x

50

x

x

Benzo 2016

Self‐management (health coaching) with PR referral vs. PR referral

12 months

∆ PAL

108

mean −0.10

106

mean 0.01

P = not significant*

step count (n)

only baseline values reported

only baseline values reported

"We did not find a difference in any physical activity outcome between the intervention and control arms at any time point"*

time sedentary

LIPA time

MPA time

VPA time

resting metabolic rate (calories per 24 hours)

total EE (calories per 24 hours)

Blumenthal 2014

Self‐management vs. education and symptom management

16 weeks

activity time

162

mean 13 (SE 1)

164

mean 11 (SE 1)

P = 0.045*

MPA time

mean 6 (SE 0.4)

mean 5.5 (SE 0.4)

0.5 (−0.6 to 1.6)

total EE ("caloric expenditure")

mean 3605 (SE 211)

mean 3113 (SE 212)

P = 0.022*

Borges 2014

Exercise training (whole‐body resistance training) vs. no intervention (inpatient)

4‐week follow‐up

time lying

15

mean 224 (SD 131)

14

mean 203 (SD 140)

21 (−78 to 120)

time sitting

mean 287 (122)

mean 298 (SD 107)

−11 (−94 to 72)

time standing

mean 168 (104)

mean 153 (SD 94)

15 (−57 to 87)

time walking

mean 31 (21)

mean 50 (SD 35)

−19 (−40 to 2)

Breyer 2010

Nordic walking with education vs. education

12 weeks

∆ time sitting

30

mean −128 (SD 15)

30

"Controls did not show any significant change in
their daily physical activities at any time point"

P = 0.014*

∆ time standing

mean 129 (SD 26)

x

∆ time walking

mean 15 (SD 20)

P = 0.034*

follow‐up (3 months post‐intervention)

∆ time sitting

mean −120 (SD 32)

P < 0.05*

∆ time standing

mean 133 (SD 14)

P < 0.05*

∆ time walking

mean 13 (SD 2)

x

follow‐up (6 months post‐intervention)

time sitting

mean 233 (SD 172)

mean 342 (SD 126)

P < 0.01*

time standing

mean 320 (SD 178)

mean 220 (SD 130)

P = 0.16

time walking

mean 56 (SD 38)

mean 32 (SD 25)

P < 0.01

Chaplin 2017

Web‐based PR vs. centre‐based PR

7 weeks

step count (n)

20

x

34

x

P = 0.37*

"20 min bouts of purposeful activity" (n)

mean change 10%

x

P = 0.26*

Charususin 2018

Inspiratory muscle training with PR vs. sham with PR

12 weeks (total n = 150)

step count (n)

x

mean 3958 (SD 2253)

x

mean 4506 (SD 1899)

−206 (−923 to 512)*

Curtis 2016

ACE inhibitor with PR vs. placebo with PR

10 weeks

∆ step count (n)

18

mean −382 (SD 2082)

22

mean 561 (SD 2528)

−943 (−2372 to 486)

∆ PAL

mean −0.06 (SD 0.16)

mean 0.04 (SD 0.15)

−0.10 (−0.20 to −0.00)

Demeyer 2017

Physical activity counselling vs. no intervention

12 weeks

∆ time walking

140

7 (1 to 13)

140

−10 (−14 to −6)

17 (10 to 24)

∆ intensity movement (m/s2)

0.06 (0.02 to 0.10)

−0.03 (−0.06 to −0.00)

0.09 (0.04 to 0.14)

∆ MVPA time

8 (5 to 12)

−3 (−6 to 0.2)

11 (7 to 15)

Duiverman 2008

Non‐invasive ventilation with PR vs. PR

12 weeks

step count (n)

24

median 2799 (IQR 891 to 6135)

32

median 2093 (IQR 914 to 3155)

median 1269 (IQR 242 to 2296)*

Felcar 2018

Water‐based exercise training vs. land‐based exercise training

6 months

active (n) (> 7500 steps per day)

20

baseline 4

end intervention 10

16

baseline 4

end intervention 5

x

Hartman 2016

Endobronchial valve surgery vs. no intervention

6 months post‐surgery

∆ step count (n)

19

1252 (545 to 1960)

24

−148 (−512 to 216)

1400 (655 to 2145)

∆ time walking (%)

1 (0 to 2)

0 (−1 to 0)

1 (0 to 2)

∆ time sitting (%)

0 (−3 to 3)

2 (1 to 3)

−2 (−5 to 1)

∆ time inactive

−1 (−3 to 1)

0 (−1 to 1)

−1 (−3 to 1)

∆ intensity movement (g)

0.01 (0.00 to 0.01)

0.00 (−0.01 to 0.00)

0.01 (0.00 to 0.02)

Hornikx 2015

Physical activity counselling vs. no intervention

4 weeks

∆ step count (n)

12

984 (217 to 1752)

14

1013 (307 to 1719)

−29 (−969 to 911)

∆ time walking

13 (3 to 23)

13 (5 to 21)

0 (−12 to 12)

∆ intensity movement (m/s2)

0.06 (0.03 to 0.09)

0.08 (−0.05 to 0.11)

−0.02 (−0.06 to 0.02)

Jolly 2018

Self‐management vs. no intervention

12 months

MVPA time a week

179

mean 347 (SD 277)

232

mean 316 (SD 256)

12 (−21 to 45)*

Kanabar 2015

Self‐management (SPACE) vs. no intervention (post‐admission)

7 days

∆ step count (n)

15

−208 (−1146 to 730)

10

−518 (−2572 to 1536)

310 (−1665 to 2285)

∆ time sedentary

−14 (−71 to 43)

−18 (−87 to 51)

4 (−75 to 83)

∆time in "physical activity"

−1 (−14 to 12)

−16 (−66 to 34)

15 (−30 to 60)

∆ MPA time

−1 (−14 to 12)

−14 (−61 to 33)

13 (−30 to 56)

∆ VPA time

0 (−1 to 1)

−2 (−61 to 2)

2 (−1 to 5)

∆ total EE (kcal)

−128 (−236 to −20)

−98 (−292 to 96)

−30 (−225 to 165)

∆ active EE (kcal)

−12 (−77 to 53)

−97 (−310 to 116)

85 (−108 to 278)

Kawagoshi 2015

Physical activity counselling with PR vs. PR

12 months

∆ time sitting

12

59 (−6 to 124)

15

6 (−44 to 56)

53 (−21 to 127)

∆ time standing

43 (24 to 60)

31 (5 to 57)

11 (−18 to 40)

∆ time walking

51 (10 to 92)

12 (−2 to 27)

39 (1 to 78)

∆ time lying

−53 (−96 to −10)

−29 (−60 to 2)

−24 (−72 to 24)

∆ frequency postural changes: total (n)

40 (−2 to 82)

19 (−5 to 43)

21 (−23 to 65)

∆ frequency postural changes: getting up (n)

0 (−16 to 16)

6 (−11 to 23)

−6 (−27 to 15)

∆ frequency postural changes: standing up (n)

43 (5 to 81)

14 (−5 to 33)

29 (−9 to 67)

Larson 2014

Exercise‐specific self‐efficacy training with upper‐body resistance training vs. upper‐body resistance training

4 months

time sedentary

15

mean 602 (SD 112)

20

mean 577 (SD 107)

25 (−49 to 99)

time sedentary (% monitored time)

mean 70 (SD 10)

mean 70 (SD 9)

0 (−6 to 6)

MVPA time

mean 6 (SD 6)

mean 4 (SD 3)

2 (−1 to 5)

Upper‐body resistance training with health education vs. health education

time sedentary

20

mean 577 (SD 107)

14

mean 634 (SD 114)

−57 (−133 to 19)

time sedentary (% monitored time)

mean 70 (SD 9)

mean 70 (SD 9)

−2 (−8 to 4)

MVPA time

mean 4 (SD 3)

mean 3 (SD 2)

1 (−1 to 3)

Loeckx 2018

Physical activity counselling with PR vs. PR

12 weeks

∆ step count (n)

25

x

25

x

MD 1319 (SE 571), P = 0.02*

∆ MVPA time

MD 8 (SE 4), P = 0.11*

9 months (follow‐up)

∆ step count (n)

MD 1348 (SE 628), P = 0.03*

∆ MVPA time

MD 13 (SE 5), P = 0.02*

Lord 2012

Singing vs. sham

8 weeks

∆ step count (n)

13

−763 (−1758 to 232)

11

1011 (337 to 1685)

−1774 (−2848 to −700)

∆ time sedentary

−36 (−113 to 41)

−27 (−72 to 18)

−9 (−88 to 71)

∆ “physical activity duration”

−93 (−224 to 38)

50 (22 to 77)

−142 (−263 to −22)

∆ "activity‐related" EE (kJ)

−144 (−408 to 119)

229 (131 to 327)

−373 (−625 to −121)

Louvaris 2016

High‐intensity interval training vs. no intervention

12 weeks

step count (n)

85

mean 5136 (SD 2866)

43

mean 3453 (SD 2493)

1683 (721 to 2646)

vector magnitude units (n)

mean 495 (SD 213)

mean 406 (SD 205)

89 (13 to 165)

"sedentarism" (%) (< 5000 steps per day)

baseline 69

end intervention 48

baseline 68

end intervention 69

x

Magnussen 2017

LAMA vs. placebo

3 weeks

∆ step count (n)

14

median 177 (IQR −222 to 1038)

15

median 86 (IQR −366 to 1000)

P = 0.63

∆ MVPA time

median −2 (IQR −12 to 26]

median −4 (IQR −16 to 19)

P = 0.51

∆ PAL

median 0.01 (IQR −0.03 to 0.07]

median 0.01 (IQR −0.06 to 0.04)

P = 0.71

∆ active EE (kcal)

median 43 (IQR −25 to 153)

median 17 (IQR −69 to 50)

P = 0.51

Mantoani 2018

Physical activity counselling with PR vs. PR

12 weeks

∆ step count (n)

22

mean 1251 (SD 2408)

22

mean −410 (SD 1118)

1661 (552 to 2770)

Mendoza 2015

Pedometer with physical activity counselling vs. physical activity counselling

12 weeks

∆ step count (n)

50

mean 3080 (SD 3255)

47

mean 138 (SD 1950)

2942 (1881 to 4003)

Mitchell 2013

Self‐management (SPACE) vs. no intervention

6 weeks

∆ step count (n)

52

333 (−85 to 751)

65

−214 (−566 to 138)

547 (12 to 1082)

∆ time sedentary

−10 (−53 to 33)

13 (−21 to 47)

−23 (−77 to 31)

∆ total EE (kcal)

−4 (−105 to 97)

−20 (−83 to 43)

16 (−100 to 132)

time in bouts (data from graph)

median 142 (95% CI 91 to 190)

median 96 (95% CI 56 to 135)

P = 0.215*

Nakamura 2016

LAMA (aclidinium bromide) vs. LAMA (tiotropium)

8 weeks

"physical activity with sedentary time"

22

x

22

x

P = 0.385*

NCT00144326

LAMA vs. placebo

12 weeks

not defined

123

x

125

x

"increase of activity in tiotropium relative to placebo from 7.9% to 12.23%"

"the majority of the mean values over time in the tiotropium group are larger than those in the placebo group"

NCT01351792

ICS (beclomethasone) with LABA (formoterol) vs. ICS (budesonide) with LABA (formoterol)

16 weeks (4‐week run‐in, 12 week intervention)

step count (n)

30

mean 3826 (SD 2097)

29

mean 3510 (SD 2409)

316 (−838 to 1470)

Ng 2015

Four‐wheeled walker vs. no intervention

4 weeks

step count (n)

8

mean 6465 (SD 4541)

minimum 3039, maximum 16,558

9

mean 2384 (SD 1319)

minimum 574, maximum 4453

4081 (818 to 7344)

N.B. no baseline assessment; likely imbalance, data skewed

Nolan 2017

Physical activity counselling with PR vs. PR

8 weeks (mid‐intervention, post‐PR)

∆ step count (n) (SenseWear)

63

median 272 (IQR −342 to 782)

59

median 155 (IQR −438 to 867)

P = 0.99*

∆ step count (n) (pedometer)

median 727 (IQR −1493 to 3119)

median 892 (IQR −1187 to 2534)

P = 0.55*

∆ MVPA time

median 11 (IQR −1 to 33)

median 11 (IQR −2 to 28)

P = 0.62*

6 months

∆ step count (n) (SenseWear)

56

median −263 (IQR −778 to 197)

57

median −461 (IQR −1168 to −62)

P = 0.09*

∆ step count (n) (pedometer)

median 116 (IQR −1698 to 3200)

median 481 (IQR −1931 to 1781)

P = 0.85*

∆ MVPA time

median 2 (IQR −12 to 25)

median 12 (IQR −7 to 31)

P = 0.16*

∆ LIPA time

44

median 13 (IQR −38 to 33)

49

median 0 (IQR −62 to 36)

P = 0.60*

∆ time sedentary

median 2 (IQR −38 to 62)

median 22 (IQR −36 to 81)

P = 0.31

O'Neill 2018

Physical activity counselling vs. PR

12 weeks physical activity counselling, 6 weeks PR

∆ MVPA time

14

7 (−10 to 24)

12

1 (−3 to 5)

6 (−10 to 22)

∆ MVPA bouts (n)

0.5 (0.2 to 1.1)

−0.03 (−0.1 to 0.05)

0.5 (0.3 to 0.8)

∆ MVPA time in bouts

9 (−4 to 22)

−0.4 (−1 to 1)

10 (−2 to 21)

Orme 2018

Feedback and education vs. no intervention; Education vs. no intervention; Feedback with education vs. education (post‐admission)

14 days

∆ step count (n)

no group data presented

"stationary" time

"light activity" time

MVPA time

Ogasawara 2018

Enriched nutritional supplement with inpatient PR vs. nutritional supplement with inpatient PR

hospital discharge

∆ step count

24

mean 1900 (SD 2110)

21

mean 1700 (SD 1694)

200 (−913 to 1313)

∆ EE (kcal)

mean 1521 (SD 285)

mean 1441 (SD 235)

80 (−72 to 232)

Priori 2017

Physical activity counselling vs. no intervention

4 weeks (mid intervention)

% ∆ MPA time

10

mean 19 (SD 30)

8

mean −5 (SD 13)

2 (4 to 45)

8 weeks

mean 20 (SD 29)

mean −12 (SD 22)

32 (8 to 55)

Probst 2011

Exercise training (callisthenics) vs. exercise training (endurance and strength training)

12 weeks (data from graph)

step count (n)

20

mean 4235 (SD 822)

20

mean 4198 (SD 680)

"There were no significant inter‐group differences in any variable"*

time walking

mean 43 (SD 26)

mean 53 (SD 39)

time standing

mean 231 (SD 123)

mean 243 (SD 106)

time sitting

mean 334 (SD 126)

mean 318 (SD 108)

time lying

mean 115 (SD 89)

mean 100 (SD 78)

MVPA time

mean 55 (SD 15)

mean 75 (SD 19)

active EE (kcal)

mean 335 (SD 104)

mean 389 (SD 119)

total EE (kcal)

mean 1362 (SD 186)

mean 1318 (SD 113)

Saini 2017

Physical activity counselling vs. no intervention

8 weeks (total n = 28)

% ∆ MPA time

x

mean −9 (SD 24)

x

mean −21 (SD 21)

P = 0.116*

Sandland 2008

Supplemental oxygen vs. placebo (air)

8 weeks

% ∆ "domestic activity counts"

10

mean 7 (SD 54)

10

mean −8 (SD 19)

15 (−21 to 51)

Sena 2013

Exercise training (eccentric cycle training)

vs. exercise training (concentric cycle training)

10 weeks

"physical activity levels"

8

x

8

x

"unchanged"*

Singh 1998

Aware of purpose of pedometer with PR vs. unaware of purpose of pedometer with PR

7 days

step count (n)

10

mean 4098

9

mean 3679

MD 419

"no significant difference between groups"*

Steele 2019

Adherence intervention vs. PR

6 months (follow‐up)

step count (n)

32

mean 5045 (SD 3147)

31

mean 5204 (SD 3261)

−159 (−1742 to 1424)

peak performance

mean 56 (SD 19)

mean 56 (SD 19)

0 (−9 to 9)

time inactive (%)

mean 68 (SD 15)

mean 70 (SD 13)

−2 (−9 to 5)

Tabak 2014a

Physical activity counselling with optional supervised exercise vs. optional supervised exercise

4 weeks

step count (n)

13

mean 5603 (SD 3475)

16

mean 4617 (SD 3460)

986 (−1553 to 3525)

Tahirah 2015

Exercise training (progressive walking and functional‐resistance exercises) vs. no intervention (inpatient)

hospital discharge

step count (n)

17

median 4215 (IQR 2133 to 6693)

17

median 2198 (IQR 1242 to 4857)

P = 0.07**

Troosters 2014

LAMA with behavioural management vs. placebo with behavioural management

6 months

step count (n)

221

mean 6485

205

mean 6122

x

MVPA time

mean 72

mean 64

MD 8

LIPA time

mean 111 (SD 82)

mean 101 (SD 80)

10 (−6 to 26)

inactive (%) (< 6000 steps per day)

mean 40

mean 43

OR 0.86 (95% CI 0.57 to 1.30) P = 0.477*

Tsai 2016

PR (telerehabilitation) vs. no intervention

8 weeks

∆ PAL

19

−0.03 (−0.1 to 0.02)

17

−0.02 (−0.1 to 0.1)

0.08 (−0.1 to 0.1)

Vasilopoulou 2017

Maintenance (telerehabilitation) following HIIT vs. no intervention

12 months (data from graph)

time sedentary

47

mean 584 (SD 98)

50

mean 615 (SD 76)

−31 (−66 to 4)

LIPA time

mean 157 (SD 44)

mean 113 (SD 44)

44 (27 to 62)

MPA time

mean 18 (SD 6)

mean 11 (SD 7)

7 (4 to 10)

"lifestyle" physical activity time

mean 41 (SD 16)

mean 34 (SD 16)

7 (1 to 13)

Maintenance (centre‐based) following HIIT vs. no intervention

time sedentary

50

mean 551 (SD 83)

50

615 (SD 76)

−64 (−95 to −33)

LIPA time

mean 159 (SD 43)

113 (SD 44)

46 (29 to 63)

MPA time

mean 22 (SD 7)

11 (SD 7)

11 (8 to 14)

"lifestyle" physical activity time

mean 52 (SD 17)

34 (SD 16)

18 (12 to 25)

Maintenance (telerehabilitation) vs. maintenance (centre‐based) following HIIT

time sedentary

47

mean 584 (SD 98)

50

mean 551 (SD 83)

33 (−3 to 69)

LIPA time

mean 157 (SD 44)

mean 159 (SD 43)

−2 (−19 to 15)

MPA time

mean 18 (SD 6)

mean 22 (SD 7)

−4 (−7 to −1)

"lifestyle" physical activity time

mean 41 (SD 16)

mean 52 (SD 17)

−11 (−18 to −4)

Watz 2017

LAMA/LABA vs. placebo

4 weeks

inactive (%) (< 6000 steps per day)

127

mean 41

123

mean 55

OR 0.27 (95% CI 0.1 to 0.5)*

Widyastuti 2018

Physical activity counselling vs. PR

6 weeks

step count (n)

18

mean 6021 (SD 2549)

18

mean 6113 (SD 2403)

−92 (−1710 to 1526)

Wootton 2017

Ground‐based walking vs. no intervention

8 weeks

time sedentary (% awake time)

62

mean 69 (SD 10)

39

mean 68 (SD 10)

−2 (−6 to 2)*

LIPA time (% awake time)

mean 25 (SD 7)

mean 25 (SD 7)

1 (−2 to 4)*

MPA time (% awake time)

mean 7 (SD 5)

mean 7 (SD 5)

1 (−2 to 4)*

VPA time (% awake time)

mean 0 (SD 0)

mean 0 (SD 0)

0 (0 to 0)*

Physical activity counselling with pedometer vs. no intervention (following ground‐based walking training)

12 months

∆ total EE (kcal)

23

−75 (−156 to 6)

20

−80 (−166 to 5)

17 (−131 to 164)*

∆ step count (n)

−157 (−753 to 439)

−1051 (−1687 to −424)

−617 (−1669 to 453)*

∆ time sedentary

−9 (−34 to 17)

−13 (−40 to 14)

−8 (−50 to 33)*

∆ LIPA time

8 (−19 to 35)

−16 (−44 to 13)

−27 (−70 to 14)*

∆ MPA time

−11 (−23 to 1)

−1 (−13 to 12)

20 (−1 to 41)*

∆VPA time

0 (−1 to 1)

0 (−1 to 1)

0 (0 to 1)*

* from paper
** from author
x data not provided
Data are per day unless indicated

ACE: angiotensin‐converting enzyme; ∆ change from baseline; cpm: counts per minute; "daily physical activity": step count + metabolic equivalents; EE: energy expenditure; ICS: inhaled corticosteroid; LABA: long‐acting beta2 agonist; LAMA: long‐acting muscarinic antagonist; LIPA: light‐intensity physical activity; MD: mean difference; METs: metabolic equivalents; MPA: moderate‐intensity physical activity; MVPA: moderate‐to‐vigorous intensity physical activity; n: number of participants; OR: odds ratio; PAL: physical activity level; PR: pulmonary rehabilitation; SPACE: self‐management programme of activity, coping and education; SD: standard deviation; VPA: vigorous‐intensity physical activity

Figuras y tablas -
Table 1. Physical activity outcomes
Summary of findings 2. Comparison of types of pulmonary rehabilitation/exercise training

Population: people with COPD, clinical stability

Intervention: pulmonary rehabilitation/exercise training

Comparisons: intervention vs. another intervention

Outcome: time in physical activity (of at least moderate intensity) at end intervention

Interventions

Outcome

Illustrative comparative risks* [mean difference (95% CI) unless indicated]

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Comparator

Intervention of interest

Home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation

(8 weeks)

Change in time in MVPA

The mean change in time in the centre‐based group was 5 minutes per day

The mean difference was 6 (−19 to 31) minutes per day

58 participants (1 study; Analysis 4.2)

⊕⊕⊝⊝
lowa

Baseline values: centre‐based median 79 (IQR 24 to 136), home‐based median 68 (IQR 29 to 121)

Calisthenics vs. exercise training

(12 weeks)

Time in MVPA

The mean time in the exercise training group was 75 minutes per day

"no significant inter‐group differences in any variable"

40 participants (1 study; Probst 2011; Table 1)

⊕⊕⊝⊝
lowb

Physical activity counselling vs. pulmonary rehabilitation

(6 to 12 weeks)

Change in time in MVPA

The mean change in time in the pulmonary rehabilitation group was 1 (−3 to 5) minutes per day

The mean difference was 6 (−10 to 22) minutes per day

26 participants (1 study; O'Neill 2018; Table 1)

⊕⊕⊝⊝
lowa

Baseline values: pulmonary rehabilitation mean 15 (SD 5), physical activity counselling mean 14 (SD 15)

Telerehabilitation maintenance programme vs. centre‐based maintenance programme

(following high‐intensity interval training, 12 months)

Time in moderate‐intensity physical activity

The mean time in the centre‐based group was 22 minutes per day

The mean difference was −4 (−7 to −1) minutes per day

97 participants (1 study; Vasilopoulou 2017; Table 1)

⊕⊕⊕⊝

moderatec

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; IQR: interquartile range; MVPA: moderate‐to‐vigorous physical activity; SD: standard deviation

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

aDowngraded one level for high risk of performance bias. Downgraded one level for imprecision as CI does not exclude possibility of no effect.

bDowngraded one level for unclear risk of selection, performance, detection, attrition and other potential bias. Downgraded one level for imprecision as CI does not exclude possibility of no effect.
cDowngraded one level for high risk of performance bias.

Figuras y tablas -
Summary of findings 2. Comparison of types of pulmonary rehabilitation/exercise training
Summary of findings 3. Physical activity counselling

Population: people with COPD, clinical stability

Intervention: physical activity counselling

Comparisons: intervention vs. no intervention, intervention in addition to a standard intervention common to both groups

Outcome: time in physical activity (of at least moderate intensity) at end intervention

Interventions

Outcome

Illustrative comparative risks* [mean difference (95% CI) unless indicated]

Number of participants (studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Comparator

Intervention of interest

Comparison: intervention vs. no intervention

Physical activity counselling vs. no intervention

(12 weeks)

Change in time in MVPA

The mean change in time was −3 (−0.6 to 0.2) minutes per day

The mean difference was 11 (7 to 15) minutes per day

280 participants (1 study; Demeyer 2017; Table 1)

⊕⊕⊕⊝

moderatea

Baseline values: no intervention median 15 (IQR 5 to 35), intervention median 14 (IQR 5 to 26)

Physical activity counselling vs. no intervention

(following pulmonary rehabilitation, 12 months)

Change in time in moderate intensity physical activity

The mean change was −1 (−13 to 12) minutes per day

The mean difference was 20 (−1 to 41) minutes per day

43 participants (1 study; Wootton 2017; Table 1)

⊕⊕⊝⊝
lowb

Baseline values: no intervention mean 51 (SD 49), intervention mean 59 (SD 52)

Comparison: intervention in addition to a standard intervention common to both groups

Physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation

(6 months)

Time in MVPA

The mean time in the pulmonary rehabilitation group was 28 minutes per day

The mean difference was 24 (2 to 45) minutes per day

26 participants (1 study; Analysis 3.21)

⊕⊕⊕⊝

moderatec

P = 0.03

Change in time in MVPA

The median change in time in the pulmonary rehabilitation group was 12 minutes per day

The median change in time was 2 (−12 to 25) minutes per day

113 participants (1 study; Nolan 2017; Table 1)

⊕⊕⊝⊝
lowd

P = 0.16

Baseline values: no intervention median 47 (IQR 18 to 103), intervention median 45 (IQR 20 to 81)

Physical activity counselling with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation

(6 months)

Change in time in MVPA

The mean change in time in the pulmonary rehabilitation group was 0 minutes per day

The mean difference was −6 (−16 to 3) minutes per day

50 participants (1 study; Analysis 3.25)

⊕⊝⊝⊝
very lowe

Baseline values: no intervention median 29 (IQR 17 to 44), intervention median 33 (IQR 16 to 47)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; IQR: interquartile range; MVPA: moderate‐to‐vigorous physical activity; SD: standard deviation

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

aDowngraded one level for high risk of performance bias and detection bias.
bDowngraded one level for high risk of performance bias. Downgraded one level for imprecision as CI does not exclude possibility of no effect.
cDowngraded one level for high risk of performance, detection and reporting bias.
dDowngraded one level for high risk of performance bias. Downgraded one level for imprecision as results do not exclude possibility of no effect.
eDowngraded one level for unclear risk of selection, reporting and other bias. Downgraded one level for imprecision as CI does not exclude possibility of no effect.

Figuras y tablas -
Summary of findings 3. Physical activity counselling
Summary of findings 4. Self‐management

Population: people with COPD, clinical stability

Intervention: self‐management

Comparisons: intervention vs. no intervention, intervention in addition to a standard intervention common to both groups, intervention vs. another intervention

Outcome: time in physical activity (of at least moderate intensity) at end intervention

Interventions

Outcome

Illustrative comparative risks* [mean difference (95% CI) unless indicated]

Number of participants (studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Comparator

Intervention of interest

Comparison: intervention vs. no intervention

Self‐management vs. no intervention

(12 months)

Time in MVPA

The mean time was 316 minutes a week

The mean difference was 12 (−21 to 45) minutes a week

411 participants (1 study; Jolly 2018; Table 1)

⊕⊕⊝⊝
lowa

P = 0.48

Comparison: intervention in addition to a standard intervention common to both groups

Self‐efficacy training with upper limb exercise vs. education with upper limb exercise

(16 weeks)

Time in moderate‐intensity physical activity

The mean time in the education and upper‐limb exercise group was 4 minutes per day

The mean difference was 2 (−1 to 5) minutes per day

35 participants

(1 study; Larson 2014; Table 1)

⊕⊕⊝⊝
lowa

Comparison: intervention vs. another intervention

Self‐management vs. education and symptom monitoring

(16 weeks)

Time in moderate‐intensity physical activity

The mean time in the self‐management group was 6 minutes per day

The mean difference was 1 (−1 to 2) minutes per day

326 participants (1 study; Blumenthal 2014; Table 1)

⊕⊕⊝⊝
lowa

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MVPA: moderate‐to‐vigorous physical activity

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

aDowngraded one level for high risk of performance bias. Downgraded one level for imprecision as CI does not exclude possibility of no effect.

Figuras y tablas -
Summary of findings 4. Self‐management
Summary of findings 5. Pharmacological interventions

Population: people with COPD, clinical stability

Intervention: pharmacological interventions

Comparisons: intervention vs. placebo, intervention in addition to a standard intervention common to both groups

Outcome: time in physical activity (of at least moderate intensity) at end intervention

Interventions

Outcome

Illustrative comparative risks* [mean difference (95% CI) unless indicated]

Number of participants (studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Comparator

Intervention of interest

Comparison: intervention vs. sham/placebo intervention

LAMA vs. placebo

(3 weeks)

Change in time in MVPA

The median change in time was −6 minutes per day

The median change in time was −1 (IQR −17 to 24) minutes per day

131 participants (2 studies; Beeh 2014; Magnussen 2017; Table 1)

⊕⊕⊕⊝

moderatea

P = 0.07

Baseline values:

Beeh 2014 placebo median 73 (IQR 38 to 135), LAMA median 74 (IQR 32 to 132)

Magnussen 2017 placebo mean 88 (SD 65), intervention mean 57 (SD 32)

LAMA/LABA vs. placebo

(3 to 4 weeks)

Change in time in MVPA

The mean change in time ranged from −16 to −1 minutes per day

The mean difference was 10 (4 to 15) minutes per day

423 participants (2 studies; Analysis 2.3)

⊕⊕⊕⊕

high

Baseline values: Watz 2016 placebo mean 130, LAMA/LABA mean 125

Comparison: intervention in addition to a standard intervention common to both groups

LAMA with behaviour modification vs. placebo with behaviour modification

(12 weeks to 6 months)

Time in MVPA

The mean time was 64 minutes per day

The mean difference was 8 minutes per day

426 participants (1 study; Troosters 2014; Table 1)

⊕⊕⊕⊝

moderateb

P = "not statistically significantly different"

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; IQR: interquartile range; LABA: long‐acting beta2 agonist; LAMA: long‐acting muscarinic antagonist; MVPA: moderate‐to‐vigorous physical activity; SD: standard deviation

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

aDowngraded one level for imprecision as results do not exclude possibility of no effect.
bDowngraded one level for imprecision as no formal analysis of difference presented.

Figuras y tablas -
Summary of findings 5. Pharmacological interventions
Table 2. Overview of results

Comparison

Description of intervention(s)

OUTCOMES

Physical activity

Health‐related quality of life

Exercise capacity

Adherence

Adverse events

TYPE OF INTERVENTION: Pulmonary rehabilitation/exercise training

Clinically stable

Intervention vs. no intervention

Pulmonary rehabilitation vs. no intervention

De Roos 2017

Y

Y

Y

N

Egan 2010

Y

Y

N

N

Tsai 2016

Y

Y

Y

Y

Wootton 2017

Y

Y

Y

Y

High‐intensity interval training vs. no intervention

Louvaris 2016

Y

Y

N

N

Vasilopoulou 2017

Y

Y

Y

Y

Vasilopoulou 2017

Maintenance (telerehabilitation) following high‐intensity interval training vs. no intervention

Maintenance (centre‐based) following high‐intensity interval training vs. no intervention

Intervention in addition to an intervention common to both groups

Nordic walking with education vs. education

Breyer 2010

Y

Y

Y

Y

Structure exercise training (COPE‐active) with self‐management vs. self management

Effing 2011

Y

Y

Y

Y

Upper limb exercises with education vs. education

Larson 2014

N

N

N

N

Exercise training and LABA with LAMA and behavioural modification vs. LAMA and behavioural modification

Troosters 2018

Y

Y

Y

Y

Exercise training with LAMA/LABA and behavioural modification vs. LAMA/LABA and behavioural modification

Exercise training and LAMA/LABA with behavioural modification vs. placebo with behavioural modification

Exercise training and physical activity counselling with pedometer vs. pedometer

Varas 2018

Y

Y

Y

N

Intervention vs. intervention

Web‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation

Chaplin 2017

Y

Y

N

Y

Exercise training (eccentric cycle training) vs. exercise training (concentric cycle training)

Sena 2013

N

Y

N

N

Home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation

Holland 2017

Y

Y

Y

Y

Water‐based exercise training vs. land‐based exercise training

Felcar 2018

Y

Y

Y

Y

Tai Chi vs. pulmonary rehabilitation

Polkey 2018

Y

Y

Y

Y

Exercise training (callisthenics) vs. exercise training (endurance and strength training)

Probst 2011

Y

Y

Y

N

Exercise training (outdoor walking) vs. exercise training (cycle ergometry)

Gamper 2019

Y

Y

N

Y

physical activity counselling vs. pulmonary rehabilitation

Widyastuti 2018

Y

Y

N

N

O'Neill 2018

Y

Y

Y

Y

Exercise training with tapering supervision vs. supervised exercise training

Rinaldo 2017

Y

Y

Y

N

Adherence intervention vs. pulmonary rehabilitation

Steele 2019

Y

Y

Y

N

Maintenance following high‐intensity interval training: telerehabilitation vs. centre‐based

Vasilopoulou 2017

Y

Y

Y

N

Acute

Intervention vs. no intervention

Exercise training vs. no intervention

Tahirah 2015

N

Y

Y

N

Borges 2014

Y

Y

Y

Y

TYPE OF INTERVENTION: Physical activity counselling

Clinically stable

Intervention vs. no intervention

Physical activity counselling vs. no intervention

Priori 2017

N

N

Y

N

Hospes 2009

Y

Y

N

Y

Altenburg 2015

Y

Y

N

Y

Demeyer 2017

Y

Y

Y

Y

Arbillaga‐Etxarri 2018

Y

Y

Y

Y

Saini 2017

N

N

N

N

Wootton 2017

Y

Y

Y

Y

Intervention in addition to an intervention common to both groups

Physical activity counselling with optional supervised exercise vs. optional supervised exercise

Tabak 2014a

Y

N

Y

N

Vorrink 2016

Y

Y

Y

N

Pedometer with physical activity counselling vs. physical activity counselling

Mendoza 2015

Y

Y

Y

N

Physical activity counselling with pedometer vs. pedometer

Bender 2016

Y

N

N

Y

Wan 2017

N

Y

Y

Y

Nguyen 2009

Y

Y

Y

Y

Moy 2015a

Y

N

Y

Y

Pedometer with pulmonary rehabilitation: aware vs. unaware of purpose of pedometer

Singh 1998

N

N

N

N

Physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation

Mantoani 2018

Y

Y

N

N

De Blok 2006

Y

Y

Y

N

Altenburg 2015

Y

Y

N

N

Cruz 2016

Y

Y

Y

N

Nolan 2017

Y

Y

Y

Y

Kawagoshi 2015

Y

Y

Y

Y

Loeckx 2018

Y

Y

N

N

Physical activity counselling with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation

Burtin 2015

Y

Y

Y

N

Acute

Intervention vs. no intervention

Physical activity counselling vs. no intervention

Hornikx 2015

Y

Y

N

Y

Feedback and education vs. no intervention

Orme 2018

Y

N

Y

Y

Education vs. no intervention

Intervention in addition to an intervention common to both groups

Feedback with education vs. education

TYPE OF INTERVENTION: Self‐management

Clinically stable

Intervention vs. no intervention

Self‐management vs. no intervention

Mitchell 2013

Y

Y

N

Y

Tabak 2014b

Y

Y

Y

N

Jolly 2018

Y

N

Y

Y

Intervention vs. sham/placebo intervention

Self‐management (health mentoring) vs. sham

Schuz 2015

Y

N

Y

Y

Intervention in addition to an intervention common to both groups

Self‐efficacy training with upper limb exercises vs. education with upper limb exercises

Larson 2014

N

N

N

N

Intervention vs. intervention

Self‐management (coping skills training) vs. education and symptom monitoring

Blumenthal 2014

Y

Y

Y

Y

Acute

Intervention vs. no intervention

Self‐management (SPACE) vs. no intervention

Kanabar 2015

N

Y

N

N

Intervention in addition to an intervention common to both groups

Self‐management (health coaching) with pulmonary rehabilitation referral vs. pulmonary rehabilitation referral

Benzo 2016

Y

N

Y

Y

TYPE OF INTERVENTION: Pharmacological treatments

Clinically stable

Intervention vs. sham/placebo intervention

LAMA vs. placebo

Beeh 2014

N

Y

N

Y

Magnussen 2017

Y

N

N

Y

NCT00144326

Y

Y

N

Y

LAMA/LABA vs. placebo

Watz 2016

N

N

Y

Y

Watz 2017

N

Y

N

Y

Intervention in addition to an intervention common to both groups

LAMA with behavioural modification vs. placebo with behavioural modification

Troosters 2014

N

N

Y

Y

Troosters 2018

Y

Y

Y

Y

LAMA/LABA with behavioural modification vs. placebo with behavioural modification

Troosters 2018

Y

Y

Y

Y

LABA with LAMA and behavioural modification vs. LAMA and behavioural modification

ACE inhibitor with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation

Curtis 2016

Y

Y

Y

Y

Intervention vs. intervention

ICS and LABA vs. ICS and LABA

NCT01351792

Y

N

N

Y

LAMA vs. LAMA

Nakamura 2016

Y

N

Y

Y

TYPE OF INTERVENTION: Nutritional supplementation

Clinically stable

Intervention vs. no intervention

Nutritional supplement vs. no intervention

Goris 2003

N

N

Y

N

Intervention vs. sham/placebo intervention

Nutritional supplement vs. placebo

Dal Negro 2012

Y

N

N

N

Intervention in addition to an intervention common to both groups

Nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation

Van de Bool 2017

Y

Y

Y

Y

Nutritional supplement with physical activity counselling vs. physical activity counselling

Acute

Intervention in addition to an intervention common to both groups

Enriched nutritional supplement with inpatient pulmonary rehabilitation vs. nutritional supplement with inpatient pulmonary rehabilitation

Ogasawara 2018

Y

N

N

N

TYPE OF INTERVENTION: Supplemental oxygen

Clinically stable

Intervention vs. sham/placebo intervention

Supplemental oxygen vs. placebo (air)

Sandland 2008

Y

Y

Y

Y

Intervention in addition to an intervention common to both groups

Supplemental oxygen with exercise training vs. sham with exercise training

Alison 2019

Y

Y

Y

Y

Intervention vs. intervention

Supplemental oxygen (lightweight ambulatory) vs. supplemental oxygen (E‐cylinder)

Casaburi 2012

N

N

Y

Y

TYPE OF INTERVENTION: Other interventions

Clinically stable

Intervention vs. no intervention

Four‐wheeled walker vs. no intervention

Ng 2015

Y

N

N

N

Endobronchial valve surgery vs. no intervention

Hartman 2016

Y

Y

N

Y

Intervention vs. sham/placebo intervention

Singing vs. sham

Lord 2012

Y

Y

Y

N

Neuromuscular electrical stimulation vs. placebo

Maddocks 2016

Y

Y

Y

Y

Intervention in addition to an intervention common to both groups

Non‐invasive ventilation with pulmonary rehabilitation vs. pulmonary rehabilitation

Duiverman 2008

Y

Y

Y

Y

Inspiratory muscle training with pulmonary rehabilitation vs. sham with pulmonary rehabilitation

Charususin 2018

Y

Y

Y

N

ACE: angiotensin‐converting enzyme; ICS: inhaled corticosteroid; LABA: long‐acting beta2 agonist; LAMA: long‐acting muscarinic antagonist; SPACE: self‐management programme of activity, coping and education

Figuras y tablas -
Table 2. Overview of results
Table 3. Health‐related quality of life outcomes

Study

Comparison (setting, if known)

Clinical stability unless indicated

Timepoint (end intervention unless indicated)

Outcome (score unless indicated)

Intervention group

Comparison group

Between‐group MD (95% CI) where available unless indicated

n

mean (95% CI) unless indicated

n

mean (95% CI) unless indicated

Altenburg 2015

Physical activity counselling vs. no intervention (primary care)

12 weeks

∆ CRQ total

22

median 2 (IQR −3 to 7)

18

median 5 (IQR −3 to 15)

P = 0.398*

∆ CCQ total

median −0.1 (IQR −0.4 to 0.1)

median −0.1 (IQR −0.4 to 0.3)

P = 0.606*

follow‐up (12 months post‐intervention)

∆ CRQ total

20

median 2 (IQR −3 to 14)

18

median 13 (IQR −1 to 15)

P = 0.278*

∆ CCQ total

median −0.1 (IQR −0.5 to 0.3)

median −0.2 (IQR −0.5 to 0.1)

P = 0.536*

Physical activity counselling vs. no intervention (secondary care)

12 weeks

∆ CRQ total

21

median 2 (IQR −6 to 11)

22

median −9 (IQR −14 to 1)

P = 0.006*

∆ CCQ total

median 0.0 (IQR −0.6 to 0.4)

median 0.1 (IQR −0.2 to 0.5)

P = 0.529*

follow‐up (12 months post‐intervention)

∆ CRQ total

20

median 6 (IQR −4 to 10)

19

median 1 (IQR −9 to 1)

P = 0.311*

∆ CCQ total

median −0.1 (IQR −0.5 to 0.2)

median 0.2 (IQR −0.3 to 0.5)

P = 0.220*

Physical activity counselling with PR vs. PR

12 weeks

∆ CRQ total

22

median 13 (IQR 3 to 20)

15

median 8 (IQR 2 to 21)

P = 0.910*

∆ CCQ total

median −1 (IQR −1 to 0.2)

median −0.2 (IQR −1 to 0.0)

P = 0.345*

follow‐up (12 months post‐intervention)

∆ CRQ total

10

median −7 (IQR −16 to 1)

13

median −5 (IQR −14 to 2)

P = 0.344*

∆ CCQ total

median 0.4 (IQR 0.1 to 1)

median 0.3 (IQR −0.2 to 0.7)

P = 0.368*

Arbillaga‐Etxarri 2018

Urban Training™ vs. no intervention

12 months

CCQ total

132

mean 1 (SD 1)

148

mean 1 (SD 1)

0.1 (−0.3 to 0.1)*

CAT

mean 11 (7)

mean 11 (7)

0.1 (−1.1 to 1.2)*

Bender 2016

Physical activity counselling with pedometer vs. pedometer

12 weeks

∆ CAT

49

x

50

x

x

∆ SGRQ

Blumenthal 2014

Self‐management vs. education and symptom monitoring

16 weeks

PQLS

162

mean 83 (SE 1)

164

mean 81 (SE 1)

P = 0.04*

SGRQ

mean 44 (SE 1)

mean 42 (SE 1)

P = 0.068*

Chaplin 2017

Web‐based PR vs. centre‐based PR

7 weeks

∆ CRQ dyspnoea domain

22

0.7 (0.2 to 1.2)

40

0.8 (0.8 to 0.8)

−0.1 (−0.7 to 0.5)

Charususin 2018

Inspiratory muscle training with PR vs. sham with PR

12 weeks (total n = 150)

CRQ dyspnoea domain

x

mean 20 (SD 6)

x

mean 19 (SD 7)

0.4 (−1.1 to 2.0)*

CRQ emotional function domain

mean 35 (SD 9)

mean 35 (SD 8)

−0.4 (−2.4 to 1.6)*

CRQ mastery domain

mean 21 (SD 5)

mean 19 (SD 5)

0.01 (−1.2 to 1.2)*

CRQ fatigue domain

mean 19 (SD 5)

mean 18 (SD 5)

0.4 (−0.8 to 1.6)*

CRQ total

mean 94 (SD 23)

mean 92 (SD 22)

−1.0 (−5.2 to 3.9)*

Curtis 2016

ACE inhibitor with PR vs. placebo with PR

10 weeks

∆ CAT

31

mean 1 (SD 4)

34

mean −1 (SD 3)

2 (0 to 4)

Dal Negro 2012

Nutritional supplementation vs. placebo

12 weeks

SGRQ total

44

mean 69 (SD 10)

44

mean 73 (SD 7)

P < 0.001*

Demeyer 2017

Physical activity counselling vs. no intervention

12 weeks

∆ CAT**

140

0 (−1 to 1)

139

1 (0 to 2)

−1 (−2 to 1)**

Duiverman 2008

Non‐invasive ventilation with PR vs. PR

12 weeks

MRF total (%)

24

mean 45 (SD 22)

32

mean 52 (SD 24)

−10 (−18 to 1)*

MRF daily activities domain (%)

mean 53 (SD 29)

mean 57 (SD 27)

−5 (−17 to 6)*

MRF cognition domain (%)

mean 28 (SD 25)

mean 41 (SD 38)

−22 (−35 to −9)*

MRF invalidity domain (%)

mean 57 (SD 33)

mean 62 (SD 36)

−6 (−19 to 7)*

SRI respiratory complaints domain (%)

mean 58 (SD 13)

mean 52 (SD 17)

6 (−1 to 12)*

SRI physical functioning domain (%)

mean 41 (SD 21)

mean 42 (SD 18)

−2 (−10 to 5)*

SRI attendant symptoms and sleep domain (%)

mean 71 (SD 16)

mean 60 (SD 20)

7 (−1 to 15)*

SRI social relationships domain (%)

mean 65 (SD 13)

mean 66 (SD 14)

1 (−6 to 8)*

SRI anxiety domain (%)

mean 63 (SD 17)

mean 57 (SD 22)

3 (−5 to 11)*

SRI well‐being domain (%)

mean 68 (SD 14)

mean 59 (SD 19)

4 (−3 to 11)*

SRI social functioning domain (%)

mean 54 (SD 16)

mean 54 (SD 18)

1 (−6 to 9)*

SRI summary (%)

mean 60 (SD 11)

mean 56 (SD 15)

3 (−2 to 8)*

Hartman 2016

Endobronchial valve surgery vs. no intervention

6 months post‐surgery

∆ SGRQ total

19

mean −16 (SD 16)

24

mean −3 (SD 9)

MD −13 (SD 4), P = 0.0005*

Hornikx 2015

Physical activity counselling vs. no intervention

4 weeks

∆ CAT

12

median −3 (IQR −10 to 1)

15

median −5 (IQR −7 to 1)

P = 0.78

Loeckx 2018

Physical activity counselling with PR vs. PR

12 weeks

∆ CRQ dyspnoea domain

25

x

25

x

MD 3 (SE 1), P = 0.04*

9 months (follow‐up)

MD 3 (SE 2), P = 0.08*

Lord 2012

Singing vs. sham

8 weeks

∆ CAT

13

−1 (−6 to 4)

11

1 (−3 to 5)

−2 (−7 to 4)

Louvaris 2016

High‐intensity interval training vs. no intervention

12 weeks

CRQ total

85

mean 98.4 (SD 21.6)

43

mean 89.1 (SD 26.1)

9.3 (0.3 to 18.4)

CCQ total

mean 2 (SD 1)

mean 2 (SD 1)

−1 (−1 to −0)

Magnussen 2017

LAMA vs. placebo

3 weeks

∆ CAT

15

−2 (−4 to 0)

15

−1 (−2 to 1)

1 (−1 to 4)**

Mantoani 2018

Physical activity counselling with PR vs. PR

12 weeks

CAT

22

median 16 (IQR 8 to 20)

22

x

x

Mendoza 2015

Pedometer with physical activity counselling vs. physical activity counselling

12 weeks

∆ SGRQ total

50

−9 (−12 to −5)

47

−4 (−7 to −1)

−5 (−10 to −0.4)

∆ CAT

−4 (−5 to −2)

−1 (−3 to 1)

−3 (−5 to −1)

Nakamura 2016

LAMA (aclidinium bromide) vs. LAMA (tiotropium)

8 weeks

SGRQ activity domain

22

x

22

x

P < 0.05*

NCT00144326

LAMA vs. placebo

12 weeks

CRQ

123

x

125

x

"no significant differences between treatments and the improvement was less than 0.5"

NCT01351792

ICS (beclomethasone) with LABA (formoterol) vs. ICS (budesonide) with LABA (formoterol)

16 weeks (4‐week run‐in, 12‐week intervention)

∆ CCQ

30

mean 0.1 (SD 0.5)

29

mean 0.1 (SD 0.5)

0.01 (−0.24 to 0.26)

Nolan 2017

Physical activity counselling with PR vs. PR

8 weeks (mid‐intervention, post‐PR)

∆ CRQ fatigue domain

63

median 2.0 (IQR 0 to 5.0)

59

median 4.0 (IQR 2.0 to 6.0)

P = 0.008*

∆ CRQ emotional function domain

3.1 (1.9 to 4.4)

5.3 (3.3 to 7.3)

−2.2 (−4.5 to 0.1)

∆ CRQ mastery domain

1.8 (1.0 to 2.7)

3.4 (2.1 to 4.7)

−1.6 (−3.1 to −0.1)

∆ CRQ total

median 11 (IQR 3 to 20)

median 20 (IQR 8 to 27)

P = 0.008*

6 months

∆ CRQ fatigue domain

56

1 (−0.3 to 2)

57

2 (0.7 to 3.4)

−1.0 (−2.8 to 0.8)

∆ CRQ emotion domain

median 0.5 (IQR −3 to 4)

2 (−1 to 6)

P = 0.12*

∆ CRQ mastery

median 0.5 (IQR −1 to 3)

2 (−2 to 5)

P = 0.29*

∆ CRQ total

median 3 (IQR −8 to 16)

10 (−2 to 19)

P = 0.07*

O'Neill 2018

Physical activity counselling vs. PR

12 weeks physical activity counselling, 6 weeks PR

∆ CAT

17

0.6 (95% CI −3.3 to 4.6)

19

−0.4 (−3.5 to 2.7)

1.1 (−3.6 to 5.7)

∆ EQ5D index

18

−0.0 (95% CI −0.1 to 0.1)

0.1 (0.0 to 0.2)

−0.10 (−0.22 to 0.01)

∆ EQ5D visual analogue scale

2.6 (95% CI −14.9 to 20.1)

13.3 (−0.9 to 27.4)

−10.7 (−31.7 to 10.3)

Orme 2018

Feedback and education vs. no intervention

14 days

CAT

8

22 (5)

6

24 (11)

−2 (−12 to 7)

Education vs. no intervention

3

23 (14)

6

24 (11)

−1 (−19 to 17)

Feedback with education vs. education

8

22 (5)

3

23 (14)

−1 (−17 to 15)

Ogasawara 2018

Enriched nutritional supplement with inpatient PR vs. nutritional supplement with inpatient PR

hospital discharge

CAT

24

median 10 (range 2 to 27)

21

10 (3 to 28)

P = 0.75*

Probst 2011

Exercise training (callisthenics) vs. exercise training (endurance and strength training)

12 weeks

SGRQ

20

mean 47 (SD 12)

20

mean 39 (SD 21)

P = 0.37*

Sandland 2008

Supplemental oxygen vs. placebo (air)

8 weeks

CRQ dyspnoea domain

10

median 2.2 (IQR 1.8 to 3)

10

median 2.5 (IQR 1.5 to 3.2)

P > 0.05*

CRQ emotional function domain

median 4.8 (IQR 3.2 to 5.7)

median 3.8 (IQR 2.6 to 5.6)

CRQ mastery domain

median 5.1 (IQR 3.2 to 5.9)

median 3.6 (IQR 2.3 to 5.0)

CRQ fatigue domain

median 3.4 (IQR 2.8 to 4.8)

median 3.3 (IQR 1.8 to 4.3)

SF36

x

x

"no significant changes in the SF36"*

Schuz 2015

Self‐management (health mentoring) vs. sham

6 months (mid‐intervention)**

SGRQ total

59

median 39 (IQR 23 to 54)

81

median 37 (IQR 29 to 58)

P = 0.439*

SGRQ symptoms domain

median 54 (IQR 32 to 79)

median 51 (IQR 37 to 72)

P = 0.226*

SGRQ activities domain

median 54 (IQR 31 to 79)

median 55 (IQR 42 to 73)

P = 0.901*

SGRQ impacts domain

median 26 (IQR 14 to 43)

median 27 (IQR 12 to 44)

P = 0.188*

SF36 physical function domain

median 39 (IQR 30 to 47)

82

median 36 (IQR 26 to 47)

P = 0.212*

SF36 role physical domain

median 46 (IQR 40 to 53)

median 46 (IQR 39 to 53)

P = 0.166*

SF36 bodily pain domain

median 52 (IQR 38 to 63)

median 51 (IQR 38 to 63)

P = 0.205*

SF36 general health domain

median 37 (IQR 30 to 44)

median 37 (IQR 29 to 46)

P = 0.696*

SF36 vitality domain

median 47 (IQR 41 to 53)

median 47 (IQR 41 to 53)

P = 0.586*

SF36 social functioning domain

median 52 (IQR 41 to 57)

median 52 (IQR 41 to 57)

P = 0.137*

SF36 role emotional domain

median 47 (IQR 40to 55)

median 47 (IQR 40 to 55)

P = 0.088*

SF36 mental health domain

median 50 (IQR 41 to 58)

median 50 (IQR 41 to 58)

P = 0.808*

SF36 physical component

median 41 (IQR 33 to 48)

median 38 (IQR 32 to 47)

P = 0.917*

SF36 mental component

median 52 (IQR 43 to 58)

median 50 (IQR 40 to 58)

P = 0.222*

12 months**

SGRQ total

65

median 42 (IQR 27 to 56)

79

median 41 (IQR 26 to 52)

P = 0.484*

SGRQ symptoms domain

median 57 (IQR 33 to 71)

median 47 (IQR 35 to 69)

P = 0.253*

SGRQ activity domain

median 60 (IQR 42 to 73)

median 55 (IQR 42 to 70)

P = 0.468*

SGRQ impacts domain

median 30 (IQR 13 to 40)

median 26 (IQR 14 to 41)

P = 0.669*

SF36 physical function domain

63

median 36 (IQR 28 to 45)

median 36 (IQR 30 to 45)

P = 0.599*

SF36 role physical domain

median 44 (IQR 39 to 51)

median 46 (IQR 40 to 53)

P = 0.354*

SF36 bodily pain domain

median 52 (IQR 42 to 63)

median 47 (IQR 38 to 63)

P = 0.392*

SF36 general health domain

median 36 (IQR 31 to 46)

median 38 (IQR 31 to 46)

P = 0.476*

SF36 vitality domain

median 47 (IQR 38 to 56)

median 50 (IQR 44 to 56)

P = 0.560*

SF36 social functioning domain

median 52 (IQR 41 to 57)

median 52 (IQR 41 to 57)

P = 0.812*

SF36 role emotional domain

median 53 (IQR 37 to 55)

median 50 (IQR 40 to 55)

P = 0.993*

SF36 mental health domain

median 50 (IQR 44 to 58)

median 50 (IQR 41 to 58)

P = 0.690*

SF36 physical component

median 40 (IQR 29 to 47)

median 39 (IQR 32 to 46)

P = 0.998*

SF36 mental component

median 52 (IQR 44 to 60)

median 52 (IQR 42 to 59)

P = 0.941*

Steele 2019

Adherence intervention vs. PR

6 months (follow‐up)

SF36 physical component

32

mean 31 (SD 8)

31

mean 31 (SD 10)

0 (−4 to 5)

SF36 mental component

mean 52 (SD 12)

mean 52 (SD 10)

0 (−6 to 6)

CCQ

mean 3 (SD 1)

mean 3 (SD 1)

0.1 (−0.5 to 0.7)

Tabak 2014a

Physical activity counselling with optional supervised exercise vs. optional supervised exercise

4 weeks

∆ CCQ total

14

−0.3 (−0.6 to −0.01)

15

0 (−0.3 to 0.3)

−0.3 (−0.7 to 0.1)*

Tsai 2016

PR (telerehabilitation) vs. no intervention

8 weeks

∆ CAT

19

−1 (−4 to 2)

17

3 (1 to 5)

−3 (−7 to 0)*

Vasilopoulou 2017

Maintenance (telerehabilitation) vs. no intervention

12 months

SGRQ total

47

mean 38 (SD 21)

50

mean 50 (SD 18)

−12 (−19 to −4)

CAT

mean 13 (SD 7)

mean 21 (SD 7)

−8 (−11 to −5)

Maintenance (centre‐based) vs. no intervention

SGRQ total

50

mean 34 (SD 17)

50

mean 50 (SD 18)

−16 (−23 to −10)

CAT

mean 12 (SD 6)

mean 21 (SD 7)

−9 (−12 to −7)

Maintenance (telerehabilitation) vs. maintenance (centre‐based)

SGRQ total

47

mean 38 (SD 21)

50

mean 34 (SD 17)

5 (−3 to 12)

CAT

mean 13 (SD 7)

mean 12 (SD 6)

1 (−2 to 4)

Widyastuti 2018

Physical activity counselling vs. PR

6 weeks

CAT

18

mean 11 (SD 5)

18

mean 9 (SD 3)

2 (−1 to 4)

* from paper
** from author
x data not provided

ACE: angiotensin‐converting enzyme; CAT: COPD assessment test; ∆: change from baseline; CCQ: clinical COPD questionnaire; CRQ: chronic respiratory disease questionnaire; EQ5D: EuroQol 5 dimensions questionnaire; ICS: inhaled corticosteroid; IQR: interquartile range; LAMA: long‐acting muscarinic antagonist; MRF: Maugeri respiratory failure questionnaire; MD: mean differences; n: number of participants; PQLS: pulmonary‐specific quality of life scale; RAND36: Dutch translation of SF36 questionnaire; SF36: Medical Outcomes Survey 36‐item short‐form health survey questionnaire; SGRQ: St George's respiratory questionnaire; SRI: severe respiratory insufficiency questionnaire

Figuras y tablas -
Table 3. Health‐related quality of life outcomes
Table 4. Exercise capacity outcomes

Study

Comparison (setting, if known)

Clinical stability unless indicated

Time point (end intervention unless indicated)

Outcome

Intervention group

Comparison group

Between‐group MD (95% CI) where available unless indicated

n

mean (95% CI) unless indicated

n

mean (95% CI) unless indicated

Altenburg 2015

Physical activity counselling vs. no intervention (primary care)

12 weeks

∆ 6MWD (m)

22

median 10 (IQR −7 to 38)

18

median 3 (IQR −18 to 22)

P = 0.291*

follow‐up (12 months post‐intervention)

20

median 20 (IQR 8 to 54)

18

median 13 (IQR −2 to 38)

P = 0.313*

Physical activity counselling vs. no intervention (secondary care)

12 weeks

21

median 23 (IQR 0 to 51)

22

median 4 (IQR −32 to 27)

P = 0.049*

follow‐up (12 months post intervention)

20

median 25 (IQR 4 to 52)

19

median 17 (IQR −9 to 57)

P = 0.555*

Physical activity counselling with PR vs. PR

12 weeks

22

median 17 (IQR −27 to 42)

15

median 25 (IQR −15 to 60)

P = 0.605*

follow‐up (12 months post intervention)

10

median 7 (IQR −32 to 51)

13

median 10 (IQR −15 to 87)

P = 0.503*

Arbillaga‐Etxarri 2018

Urban Training™ vs. no intervention

12 months

6MWD (m)

132

488 (106)

148

493 (90)

−2 (−11 to 8)*

Beeh 2014

LAMA vs. placebo

3 weeks

∆ endurance time (sec)**

54

median 26 (IQR −106 to 117)

54

median −16 (IQR −109 to 18)

P = 0.093*

Blumenthal 2014

Self‐management vs. education and symptom monitoring

16 weeks

6MWD (m)

162

mean 361 (SE 3)

164

mean 351 (SE 3)

P = 0.03*

Chaplin 2017

Web‐based PR vs. centre‐based PR

7 weeks

∆ ESWT (sec)

22

189 (95 to 283)

40

185 (105 to 264)

5 (−112 to 121)

Charususin 2018

Inspiratory muscle training with PR vs. sham with PR

12 weeks

6MWD (m)

n = 169

x

mean 388 (SD 113)

x

mean 407 (SD 105)

1 (−13 to 15)*

endurance time (sec)

n = 139

mean 496 (SD 309)

mean 466 (SD 292)

98 (17 to 179)*

peak work rate (W) n = 92

mean 64 (SD 26)

mean 59 (SD 22)

5.2 (−0.4 to 10.8)*

VO2peak (mL/min) n = 92

mean 1048 (SD 313)

mean 966 (SD 323)

0.01 (−0.1 to 0.1)*

VEpeak (L/min) n = 92

mean 37 (SD 11)

mean 39 (SD 15)

−1 (−3 to 2)*

Curtis 2016

ACE inhibitor with PR vs. placebo with PR

10 weeks

∆ peak work rate (W)

31

1 (−2 to 4)

34

9 (5 to 13)

−8 (−13 to −3)

∆ VO2peak (mL/min/kg)

0.3 (−0.4 to 1.1)

1.4 (0.8 to 2.0)

−1.0 (−2.0 to −0.1)

∆ VE/VCO2 slope

−0.9 (−2.1 to 0.4)

−1.3 (−3.2 to 0.7)

0.4 (−2.0 to 2.8)

∆ oxygen uptake efficiency slope (ml/min)

29 (−109 to 167)

151 (40 to 261)

−122 (−292 to 49)

De Blok 2006

Physical activity counselling with PR vs. PR

9 weeks

2‐min step test (n steps)

8

57 (32 to 82)

8

55 (37 to 73)

2 (−24 to 28)

Demeyer 2017

Physical activity counselling vs. no intervention

12 weeks

∆ 6MWD (m)

131

mean 12 (SD 44)

136

mean −1 (SD 44)

13 (2 to 23)

Duiverman 2008

Non‐invasive ventilation with PR vs. PR

12 weeks

ESWT (sec)

24

median 475 (IQR 295 to 1010)

32

449 (213 to 1042)

103 (−69 to 276)*

6MWD (m)

mean 340 (SD 119)

mean 325 (SD 108)

2 (−19 to 23)*

VO2peak (mL/min/kg)

mean 9.8 (SD 2.9)

mean 9.5 (SD 3.0)

0.3 (−0.9 to 1.4)*

Gamper 2019

Exercise training (outdoor walking) vs. exercise training (cycle ergometry)

3 weeks

6MWD (m)

8

mean 285 (SD 72)

8

mean 440 (SD 49)

−155 (−215 to −95)

Hartman 2016

Endobronchial valve surgery vs. no intervention

6 months post‐surgery

∆ 6MWD (m)

19

mean 84 (SD 62)

24

mean −20 (SD 35)

MD 104 (SD 165)*

Hornikx 2015

Physical activity counselling vs. no intervention

4 weeks

∆ 6MWD (m)

12

mean 67 (SD 84)

15

mean 64 (SD 59)

3 (−53 to 59)

Hospes 2009

Physical activity counselling vs. no intervention

12 weeks

6MWD (m)

18

mean 387 (SD 47)

17

mean 361 (SD SD 67)

26 (−12 to 64)

Kanabar 2015

Self‐management vs. no intervention (post‐admission)

7 days

∆ ISWD (m)

15

mean 46 (SD 32)

10

mean 44 (SD SD 99)

2 (−62 to 66)

∆ ESWT (sec)

mean 369 (SD 355)

mean 290 (SD SD 379)

80 (−216 to 375)

Kawagoshi 2015

Physical activity counselling with PR vs. PR

12 months

6MWD (m)

12

mean 445 (SD 138)

15

mean 467 (SD SD 151)

−22 (−131 to 87)

Loeckx 2018

Physical activity counselling with PR vs. PR

12 weeks

∆ 6MWD (m)

25

x

25

x

MD 8 (SE 14), P = 0.59*

∆ endurance time (sec)

MD −80 (SE 71), P = 0.26*

9 months (follow‐up)

∆ 6MWD (m)

MD 2 (SE 16), P = 0.90*

∆ endurance time (sec)

MD 153 (SE 79), P = 0.06*

Lord 2012

Singing vs. sham

8 weeks

∆ ISWD (m)

13

−7 (−35 to 21)

11

15 (−11 to 40)

−22 (−56 to 12)

Louvaris 2016

High‐intensity interval training vs. no intervention

12 weeks

VO2peak (mL/min/kg)

85

mean 17.8 (SD 4)

43

mean 15.5 (SD 4.1)

2.3 (0.8 to 3.8)

Mantoani 2018

Physical activity counselling with PR vs. PR

12 weeks

∆ESWT (sec)

22

99 (37 to 161)

22

3 (−34 to 40)

96 (28 to 164)

Mendoza 2015

Pedometer with PAI vs. PAI

12 weeks

∆6MWD (m)

50

mean 12 (SD 35)

47

mean −1 (SD 24)

13 (1 to 25)

NCT00144326

LAMA vs. placebo

12 weeks

6MWD (m)

123

x

125

x

"trend favouring tiotropium"

Nguyen 2009

Physical activity counselling with pedometer vs. pedometer

6 months

peak work rate (W)

9

mean 49 (SD 24)

8

mean 49 (SD 28)

0 (−25 to 25)

Nolan 2017

Pedometer with PR vs. PR

8 weeks (mid‐intervention, post‐PR)

∆ ISWD (m)

63

median 60 (IQR 20 to 90)

59

median 50 (IQR 10 to 90)

P = 0.83*

6 months

56

median 30 (IQR 0 to 70)

57

median 10 (IQR −30 to 70)

P = 0.25*

O'Neill 2018

Physical activity counselling vs. PR

12 weeks physical activity counselling, 6 weeks PR

∆ ISWD (m)

16

−12 (−60 to 36)

17

−8 (−44 to 28)

−4 (−60 to 51)

Probst 2011

Exercise training (callisthenics) vs. exercise training (endurance and strength training)

12 weeks

peak work load (W)

20

mean 30 (SD 30)

20

mean 48 (SD 30)

P = 0.04*

endurance time (min)

mean 8 (SD 7)

mean 17 (SD 24)

P = 0.08*

6MWD (m)

mean 424 (SD 114)

mean 483 (SD 89)

P = 0.30*

Sandland 2008

Supplemental oxygen vs. placebo (air)

8 weeks

ISWD (m)

10

mean 251 (SD 136)

10

mean 211 (SD 99)

40 (−64 to 144)

ESWT (sec)

mean 340 (SD 336)

mean 170 (SD 98)

170 (−47 to 387)

Sena 2013

Exercise training (eccentric cycle training) vs. exercise training (concentric cycle training)

10 weeks

∆ peak work rate (W)

8

9 (3 to 15)

8

12 (5 to 19)

−3 (−11 to 5)

Steele 2019

Adherence intervention vs. PR

6 months (follow‐up)

6MWD (m)

32

mean 320 (SD 134)

31

mean 315 (SD 116)

5 (−57 to 67)

Tabak 2014b

Self‐management vs. no intervention

12 weeks (mid‐intervention)

6MWD (m)

11

mean 412 (SE 39)

9

mean 312 (SE 44)

100 (−15 to 215)

Tahirah 2015

Exercise training (progressive walking and functional‐resistance exercises) vs. no intervention (inpatient)

hospital discharge

2‐min walk distance (m)

16

mean 162 (SD 38)

16

mean 146 (SD 4)

13 (3 to 23)*

Van de Bool 2017

Nutritional supplementation with PR vs. placebo with PR

4 months (end intervention)

6MWD (m)

38

mean 500 (SD 111)

35

mean 492 (SD 101)

MD −4 (SD 12)*

endurance time (sec)

mean 467 (SD 339)

mean 482 (SD 372)

MD −110 (SD 70)*

12 months (end maintenance)

∆ endurance time (sec)

32

mean 107 (SD 63)

29

mean 200 (SD 65)

MD −93 (SD 90)*

Vasilopoulou 2017

Maintenance (telerehabilitation) vs. no intervention

12 months

6MWD (m)

47

mean 420 (SD 75)

50

mean 340 (SD 110)

80 (43 to 118)

peak work rate (W)

mean 76 (SD 35)

mean 58 (SD 24)

18 (6 to 30)

Maintenance (centre‐based) vs. no intervention

6MWD (m)

50

mean 428 (SD 63)

50

mean 340 (SD 110)

88 (52 to 123)

peak work rate (W)

mean 79 (SD 31)

mean 58 (SD 24)

21 (10 to 32)

Maintenance (telerehabilitation) vs. maintenance (centre‐based)

6MWD (m)

47

mean 420 (SD 75)

50

mean 428 (SD 63)

−7 (−35 to 20)

peak work rate (W)

mean 76 (SD 35)

mean 79 (SD 31)

−3 (−16 to 10)

Wan 2017

Physical activity counselling with pedometer vs. pedometer

12 weeks

∆ 6MWD (m)

57

mean −1 (SD 56)

52

mean 4 (SD 47)

P = 0.72*

Watz 2017

LAMA/LABA vs. placebo

8 weeks (4 weeks medication only, 4 weeks medication and behavioural intervention)

endurance time (sec)

127

51 (15 to 86)

123

−5 (−40 to 31)

LSMD 55 (95% CI 6 to 105)*

Widyastuti 2018

Physical activity counselling vs. PR

6 weeks

6MWD (m)

18

mean 242 (SD 79)

18

mean 267 (SD 47)

−25 (−68 to 18)

Wootton 2017

Physical activity counselling with pedometer vs. no intervention (following ground‐based walking training)

12 months

∆ 6MWD (m)

35

−23 (−41 to −5)

36

−39 (−59 to −18)

−16 (−46 to 15)*

∆ ISWD (m)

28

−37 (−60 to −14)

−8 (−34 to 17)

23 (−13 to 60)*

∆ ESWT (sec)

29

−110 (−232 to 12)

−168 (−303 to −33)

−54 (−245 to 137)*

* from paper
x data not provided

ACE: angiotensin‐converting enzyme; ∆: change from baseline; ESWT: time walked during an endurance shuttle walk test; ISWD: distance walked during an incremental shuttle walk test; IQR: interquartile range; LSMD: least squares mean difference; m: metres; D: mean difference; n: number of participants; sec: seconds; SPACE: self‐management programme of activity, coping and education; 6MWD distance walked on six‐minute walk test; SD: standard deviation; VO2peak: peak oxygen uptake

Figuras y tablas -
Table 4. Exercise capacity outcomes
Table 5. Adherence

Study

Comparison (setting); Clinical stability unless indicated

Data regarding adherence

Alison 2019

Supplemental oxygen with exercise training vs. sham with exercise training

Attended ≥ 16 sessions; oxygen 48 participants; sham 41 participants

Arbillaga‐Etxarri 2018

Urban Training™ vs. no intervention

Urban training (132 participants)

  • "Non adherent patients who (I) spontaneously reported at baseline that they were unwilling to follow any of the instructions, or (ii) spontaneously reported at the 12 months visit that they had not been adherent to the study protocol"

  • Website 2%, at least 1 walking group 31%, trail maps 70%, calendars 87%, pedometers 90%

  • 65% of participants returned calendars, completed 9 (4) months

Benzo 2016

Self‐management (health coaching) with PR referral vs. PR referral

Attendance at PR:

  • 3 months: self‐management with PR referral 50%; PR referral 33%; P = 0.017

  • 12 months: self‐management with PR referral 53%; PR referral 43%; P = 0.056

85% of participants completed self‐management intervention (≥ 15 of 21 calls)

Blumenthal 2014

Self‐management (coping skills training) vs. education and symptom monitoring

Both groups: median number of completed sessions 14 (100%)

Borges 2014

Exercise training (whole‐body resistance training) vs. no intervention (inpatient)

Attendance: 5.6 sessions (95%); Intensity (weight load): increase 9.7%

Breyer 2010

Exercise training (Nordic walking) with education vs. education

"All patients achieved the preset goal for maximum heart rate to ensure training efficiency (> 75% of the initial maximum heart rate)… none of the patients had any difficulties in performing Nordic Walking adequately"

Burtin 2015

Physical activity counselling with PR vs. sham with PR

PR: "did not systematically record adherence"; Physical activity counselling/sham (8 scheduled sessions): 82% attendance

Casaburi 2012

Supplemental oxygen (lightweight ambulatory) vs. supplemental oxygen (E‐cylinder)

Oxygen use: lightweight ambulatory 8.9 (4.8) hours per day; E‐cylinder 16.9 (3.9) hours per day

Charususin 2018

Inspiratory muscle training with PR vs. sham with PR

Completed prescribed sessions of inspiratory muscle training: inspiratory muscle training 79 (4)%; PR 81 (4)%

Intensity (inspiratory muscle training load relative to baseline Pimax): 47 (2)% Week 1; 84 (4)% Week 12

Cruz 2016

Physical activity counselling with PR vs. PR

"All participants received allocated intervention"

Curtis 2016

ACE inhibitor with PR vs. placebo with PR

  • Attendance: inhibitor mean 11 (95% CI 10 to 12); placebo 13 (12 to 14); P = 0.002 "the actual difference was small and unlikely to have provided a more favourable training stimulus in the placebo group"

  • Drug compliance: inhibitor 96% (95% CI 94 to 99); placebo 96% (93 to 98); P = 0.45

De Blok 2006

Physical activity counselling with PR vs. PR

Physical activity counselling: individual exercise counselling 4 sessions attended, diary‐recorded daily step counts 96%

De Roos 2017

Exercise training vs. no intervention

Exercise training attendance 18.2 (1.1) of 20 scheduled sessions, home‐based walking 8.6 (0.4) sessions

Demeyer 2017

Physical activity counselling vs. no intervention

PAC median 6 (IQR 4 to 9) contacts (range 0 to 25)

Duiverman 2008

Non‐invasive ventilation with PR vs. PR

PR

  • Attendance: NIPPV and PR 39 (4) sessions, 87%; PR 40 (4) sessions, 89%

  • Intensity (target peak workload 140% baseline): NIPPV and PR median 140% (IQR 57 to 500); PR 140% (63 to 350)

  • Completion (not defined): three (9%) participants "did not complete the study because of non‐compliance"

NIPPV

  • Completion: 5 (16%) participants "could not adapt"

  • Adherence: 96% days, median 7.7 (IQR 5.8 to 8.5) hours per day (data for completers only)

Effing 2011

Exercise training (COPE‐active) with self‐management vs. self management

COPE‐active 56 (73%) participants completed (not defined)

Felcar 2018

Water‐based exercise training vs. land‐based exercise training

"All studied patients completed 60 sessions"

Goris 2003

Nutritional supplement vs. no intervention

Adherence: nutritional supplement 95 (6)% Month 1; 89 (14)% Month 3

Holland 2017

Home‐based PR vs. centre‐based PR

  • Attendance: home‐based 7.4 of eight scheduled sessions, weekly diary: 5 unsupervised exercise sessions, walking duration 32 (7) min, 4 (1) resistance exercises; centre‐based 8.3 of 16 scheduled sessions

  • Completion (defineda priori ≥ 70% sessions): home‐based n = 73 (91%) sessions; centre‐based n = 42 (49%) sessions; relative risk for non‐completion in centre‐based group: 1.91 (95% CI 1.52 to 2.41)

Jolly 2018

Self‐management vs. no intervention

Self‐management 999 (86%) of 1156 calls, participated in all 4 scheduled calls 218 (75%) of 289 participants

Kawagoshi 2015

Physical activity counselling with PR vs. PR

Days of home‐based PR: 239 (25) days a year, 65 (7)%, 4 days a week

Days of pedometer wear: 293 (49) days a year, 80 (13)%

Lord 2012

Singing vs. sham

Attendance: singing 14.5 of 16 scheduled sessions; sham 7 of 8 scheduled sessions

Maddocks 2016

NMES vs. placebo

Intervention: 42 sessions (1260 minutes)

  • Recorded sessions: NMES mean 34 (SD 14); placebo 33 (18); P = 0.84

  • Recorded duration (min): NMES 923 (546); placebo 938 (588); P = 0.93

Mendoza 2015

Pedometer with physical activity counselling vs. physical activity counselling

Physical activity counselling and pedometer strong correlations between diary and device memory step count (r2 Month 1 0.996, Month 2 0.999, Month 3 0.975) "suggesting a high degree of compliance with the program."

Moy 2015a

Physical activity counselling with pedometer vs. pedometer

Valid step‐count data

  • 12 months: Physical activity counselling with pedometer 77 (29)% days; pedometer 64 (33)% days; P = 0.002

  • Last 6 weeks: Physical activity counselling with pedometer 88 (17)% days; pedometer 74 (28)% days; P < 0.001

Physical activity counselling with pedometer:

  • Days of valid step‐count data: Month 1 92% (95% CI 87 to 98); Month 12 70% (65 to 76); P < 0.001

  • Number of website logins: Month 1 6.8 (3.7), median 6 (IQR 3); Month 12 3.0 (3.0), median 3 (IQR 5); P < 0.001

Nakamura 2016

LAMA (aclidinium bromide) vs. LAMA (tiotropium)

Adherence (both groups) "estimated to be 100% during study period"

Nguyen 2009

Physical activity counselling with pedometer vs. pedometer

Exercise and symptom data submitted: PAC with pedometer 87%; pedometer 66%

Nolan 2017

Physical activity counselling with PR vs. PR

Physical activity counselling with PR (revised step‐count goal, 5% increments, 8 possible occasions) did not occur 5 (10) occasions

O'Neill 2018

Physical activity counselling vs.PR

  • Physical activity counselling: Dropouts/non‐starters: 26% (6 of 23 allocated participants)

Attended 75% sessions: 100%; mean 11.8 (SD 0.6) of 12 planned consultations

  • PR: Dropouts/non‐starters: 50% (13 of 23 allocated participants)

Attended 75% sessions: 70% (9 of 13 participants); mean 10.5 (SD 1.2) of 12 planned classes

Orme 2018

Feedback and education vs. no intervention;

Education vs. no intervention; Feedback with education vs. education (post‐admission)

Intervention delivery: feedback and education 21 (95%) sessions ; education 1 session not delivered

Polkey 2018

Tai Chi vs. PR

"Both groups had high compliance in terms of attendance rate (present days/total expected days)" Tai Chi 91 (1)%; PR 87 (2)%

Priori 2017

Physical activity counselling vs. no intervention

Days accessed website: Physical activity counselling 87 (15)%

Probst 2011

Exercise training (callisthenics) vs. exercise training (endurance and strength training)

Attendance (32 planned sessions): callisthenics 19 (61%) sessions; endurance and strength training 20 (63%) sessions

Rinaldo 2017

Exercise training with tapered supervision vs. supervised exercise training

Attendance: exercise training with tapered supervision 100%; supervised exercise training 87%

Sandland 2008

Supplemental oxygen vs. placebo (air)

Number of cylinders used: oxygen 20.2 (13.7); placebo 10.7 (4.9); P < 0.002

Schuz 2015

Self‐management (health mentoring) vs. sham

Attendance: phone contacts median 9.5 of 16 planned sessions (range 1 to 21)

Steele 2019

Adherence intervention vs. PR

Attended ≥ 80% sessions: Adherence intervention: 80% (37 of 46 allocated participants); PR: 57% (25 of 44 allocated participants)

Tabak 2014a

Physical activity counselling with optional supervised exercise vs. optional supervised exercise

Physical activity counselling activity coach: 86% "complied" [time activity coach was worn], wear time 17.5 (2.2) days (109% of prescribed), 588 (101) min per day

Physical activity counselling diary: 1 participant "complied" (completed diary every day), 1 participant did not use the web portal, 1 participant used web portal for 4 days; completed 17.3 (7.8) times a patient (58% of prescribed)

Tabak 2014b

Self‐management vs. no intervention

Web portal: 86% of days

Triage diary: most used module (median 83%)

Exercise: 127 exercise schemes performed of 569 schemes prescribed (median 21%)

Activity coach‐module: used for 299 days (132 days in monitoring mode, 167 days in feedback mode), "rarely used outside of the measurement weeks"

Varas 2018

Physical activity counselling and exercise training with pedometer vs. pedometer

"2 (participants) were excluded for non‐compliance during the intervention phase"

Author correspondence states "non‐compliance of the program was established previously, before starting the study, by considering none achieving the individual target of steps/week for three consecutive weeks"

Vasilopoulou 2017

Maintenance (telerehabilitation) vs. no intervention;

Maintenance (centre‐based) vs. no intervention;

Maintenance (telerehabilitation) vs. maintenance (centre‐based) following high‐intensity interval training

"Adherence to the home‐based maintenance tele‐rehabilitation and hospital‐based, outpatient, maintenance programmes were assessed by the adherence rate (actual number of sessions/total expected number of session×100). Adherence to measurements of vital signs, home exercises, responses to questionnaires and daily steps were recorded for each participant by the number of registrations entered divided by the number of those recommended."

"Overall compliance rate" (twice‐weekly supervised exercise training sessions): telerehabilitation 93.5%; centre‐based 91%

Vorrink 2016

Physical activity counselling with optional supervised exercise vs. optional supervised exercise

App accessed: PAC with optional supervised exercise 89 (19)% days, accessed app and personal physical activity goal obtained 34 (16)% days

Wan 2017

Physical activity counselling with pedometer vs. pedometer

Pedometer

  • Compliance ("surrogate for exercise adherence"): Physical activity counselling and pedometer 86%; pedometer 87%

  • Wear time: Physical activity counselling and pedometer 15.2 (2.4) hours per day; pedometer 16.1 (6.3) hours per day; P = 0.84

Website use: Physical activity counselling and pedometer > 4 logins a month "suggests good adherence to the requested weekly logins" (data not shown)

Watz 2016

LAMA/LABA vs. placebo

Combined treatment periods 1 and 2: LAMA/LABA 99.5%; placebo 99.6%

Wootton 2017

Exercise training (ground‐based walking) vs. no intervention

Attendance: 18 (6) of 24 scheduled sessions; Progression (duration): 76 (84%) participants

Physical activity counselling with pedometer vs. no intervention (following ground‐based walking)

% Adherence (number of walks reported divided by the number of prescribed walks)

Physical activity counselling: 8 months mean 52 (SD 17); 14 months 52 (55)

No intervention: 8 months mean 92 (SD 38); 14 months 77 (54)

Data are mean or mean (SD) unless indicated
ACE: angiotensin‐converting enzyme; COPD: chronic obstructive pulmonary disease; LABA: long‐acting beta2‐agonist; LAMA: long‐acting muscarinic antagonist; min: minutes; n: number; Pimax: maximal inspiratory mouth pressure

Figuras y tablas -
Table 5. Adherence
Table 6. Adverse events

Study

Comparison (setting), if known]

Clinical stability unless indicated

Data regarding adverse events

Alison 2019

Supplemental oxygen with exercise training vs. sham with exercise training

AE: incidence and severity similar in both groups

  • Oxygen: 1 participant atrial fibrillation during training, 1 participant syncopal episode on the way to training, 1 participant death (not study‐related)

  • Sham: 1 participant mild stroke after training, 1 participant minor heart attack (non‐training day)

Altenburg 2015

Physical activity counselling vs. no intervention

(primary care, secondary care); Physical activity counselling with PR vs. PR

Monitoring for AEs described, no results presented: "WA had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis, including and especially any AEs"

Arbillaga‐Etxarri 2018

Urban Training™ vs. no intervention

Participants experiencing any AE: Urban Training 99 (77%) of 128 participants; no intervention 103 (73%) of 142 participants; P = 0.363

  • Respiratory AEs

    • Cold, flu or pneumonia: Urban Training 21 (16%) participants; no intervention 24 (17%) participants; P = 0.913

    • Dypsnoea: Urban Training 46 (36%) participants; no intervention 48 (34%) participants; P = 0.713

  • Musculoskeletal AEs

    • Lower‐extremity muscle pain: Urban Training 48 (38%) participants, no intervention 36 (25%) participants; P = 0.031

    • Lower‐extremity joint pain: Urban Training 41 (32%) participants, no intervention 38 (27%) participants; P = 0.342

  • Other AEs (dizziness, faint, general malaise/fatigue, chest discomfort, palpitations, fall, twist or accident, heatstroke/dehydration): between‐group differences all P > 0.05

Beeh 2014

LAMA vs. placebo

SAEs: none; AEs leading to discontinuation: LAMA 4 events in 57 participants; placebo 1 event in 53 participants

Bender 2016

Physical activity counselling with pedometer vs. pedometer

"No withdrawals due to AEs"

Benzo 2016

Self‐management (health coaching) with PR referral vs. PR referral

"Reasons for not completing the intervention were death during the study period (n = 3)" (108 participants)

Blumenthal 2014

Self‐management (coping‐skills training) vs. education and symptom monitoring

Education and symptom monitoring: 3 participants died during the intervention period

Borges 2014

Exercise training (whole‐body resistance training) vs. no intervention (inpatient)

"No patients exhibited clinical deterioration except oxygen desaturation (oxygen saturation by pulse oximeter <88%) and increased dyspnoea, which were reversed with oxygen or increasing supplemental oxygen"

Breyer 2010

Nordic walking with education vs. education

"No (serious) AEs were reported"

Casaburi 2012

Supplemental oxygen (lightweight ambulatory) vs. supplemental oxygen (E‐cylinder)

AEs: lightweight ambulatory 1 death (sudden) in 11 participants; E‐cylinder 1 death (congestive heart failure) in 11 participants

Chaplin 2017

Web‐based PR vs. centre‐based PR

Monitoring for AEs described, no results presented: "Any SAEs were reported to the sponsor. A SAE was defined as an acute exacerbation of their COPD that resulted in a hospital admission"

Curtis 2016

ACE inhibitor with PR vs. placebo with PR

AECOPD or AE: no difference between groups

  • ACE inhibitor: 2 participants significant decline in renal function, withdrawn from the study; 1 patient persistent cough, did not lead to treatment cessation

Demeyer 2017

Physical activity counselling vs. no intervention

Respiratory AEs (≥ 1 AECOPD): physical activity counselling 43 (27%) of 159 participants; no intervention 48 (30%) of 159 participants; P = 0.54; 5 participants required hospitalisation

Musculoskeletal AEs (back pain, knee pain, rib fracture): physical activity counselling 11 events; no intervention 2 events; P = 0.01; none caused study discontinuation

8 other AEs (not study‐related: cardiovascular problems, melanoma, urinary problems, gastrointestinal problems)

Duiverman 2008

Non‐invasive ventilation with PR vs. PR

Respiratory AEs: Non‐invasive ventilation 1 death ("progressive respiratory failure due to COPD exacerbation") in 24 participants

Musculoskeletal AEs: Non‐invasive ventilation 1 withdrawal ("rheumatic complaints")

Effing 2011

Exercise training (COPE‐active) with self‐management vs. self management

AEs: none reported

Felcar 2018

Water‐based exercise training vs. land‐based exercise training

Participant discontinuations due to "health problems"

  • water‐based exercise training one orthopaedic complication, 6 other complications (cancer, diabetes complication, depression, abdominal hernia) in 7 of 34 participants

  • land‐based exercise training 8 orthopaedic complications, 3 other complications (vascular disease, intestinal infection) in 8 of 36 participants

Gamper 2019

Exercise training (outdoor walking) vs. exercise training (cycle ergometry)

During rehabilitation: no AE

During follow‐up: ergometry 3 participants AECOPD

Walking: unable to use HR monitor as planned, required chest strap; difficult for 70% of participants; resolved using modified Borg scale to guide training intensity

Hartman 2016

Endobronchial valve surgery vs. no intervention

AEs: endobronchial valve surgery 1 death, 8 valves removed in 19 participants

Holland 2017

Home‐based PR vs. centre‐based PR

AEs: none

Hornikx 2015

Physical activity counselling vs. no intervention

Respiratory AEs

  • restart oral corticosteroids: physical activity counselling 6 events in 12 participants; no intervention 5 events in 14 participants; P = 0.93

  • hospitalisation for AECOPD: Physical activity counselling 4 participants; no intervention 6 participants; P = 0.72

Hospes 2009

Physical activity counselling vs. no intervention

AEs: no intervention 1 death in 17 participants

Jolly 2018

Self‐management vs. no intervention

SAEs: self‐management 24 of 179 participants; no intervention 20 of 232 participants

  • self‐management 5 deaths (not study‐related: cor pulmonale, stroke, ruptured aortic aneurysm, malignancy)

Kawagoshi 2015

Physical activity counselling with PR vs. PR

AEs: Physical activity counselling with PR 1 death in 12 participants; PR 1 death in 15 participants

Maddocks 2016

NMES vs. placebo

Similar between groups;

AE: NMES 5 (20%) participants; placebo 9 (33%) participants

  • AECOPD requiring antibiotics: NMES 4 (16%) participants; placebo 7 (26%) participants

  • AECOPD requiring hospital admission and oral corticosteroids; NMES 3 (12%) participants; placebo 6 (22%) participants; P = 0.22

  • Laryngeal cancer: 1 (4%) participant

  • Persistent erythema: 2 participants (1 from each group); possibly related to NMES and use of adhesive electrodes

Magnussen 2017

LAMA vs. placebo

SAEs: none; AEs: were all "mild or moderate", not study‐related, no withdrawals

Mitchell 2013

Self‐management (SPACE) vs. no intervention

AEs: SPACE five participants with comorbidities, one participant with "worsening of COPD" in 89 participants; no intervention five participants with comorbidities, one death in 95 participants

Moy 2015a

Physical activity counselling with pedometer vs. pedometer

Musculoskeletal AEs ("mild / minor"):

  • 4‐month data Physical activity counselling with pedometer 41 events, pedometer 4 events; P = 0.003

  • 12‐month data Physical activity counselling with pedometer 43 (28%) of 145 participants, pedometer 8 (10%) of 84 participants; P < 0.001

Deaths:

  • 4‐month data Physical activity counselling with pedometer 2 deaths

  • 12‐month data Physical activity counselling with pedometer 6 (4%) deaths; pedometer 2 (2%) deaths; P = 0.53

Four‐month data

  • AEs: Physical activity counselling with pedometer 6 pulmonary events, 3 cardiac events, 5 other events; pedometer 1 pulmonary event, 1 cardiac event, 3 other events; other: falls, hypoglycaemia, foot blisters, nerve pain, neuropathy, feet numbness

  • COPD‐related AEs that did not require hospitalisation: PAC with pedometer 8 events; pedometer 1 event

12‐month data "no differences between groups with respect to pulmonary, cardiac or other adverse events"

  • Respiratory AEs

    • AECOPD/pneumonia: Physical activity counselling with pedometer 35 (23%) participants; pedometer 5 (18%) participants; OR 1.4 (95% CI 0.7 to 2.8); P = 0.33

    • hospitalisation: Physical activity counselling with pedometer 36 (23%) participants; pedometer 14 (17%) participants; OR 1.6 (95% CI 0.8 to 3.2); P = 0.19

    • emergency room visits: Physical activity counselling with pedometer 46 (30%) participants; pedometer 20 (24%) participants; OR 1.4 (95% CI 0.8 to 2.6); P = 0.27

Nakamura 2016

LAMA (aclidinium bromide) vs. LAMA (tiotropium)

AEs: aclidinium bromide 9 events in 22 participants; tiotropium 7 events in 22 participants

NCT00144326

LAMA vs. placebo

“No relevant issues concerning safety were found”

Any AE: LAMA 44 (36%) participants, placebo 56 (44%) participants

  • Respiratory (lower) disorder: LAMA 42 (34%) participants; placebo 60 (47%) participants

  • Respiratory (upper) disorder: LAMA 34 (28%) participants; placebo 50 (39%) participants

    • AECOPD: LAMA 11 (9%) participants; placebo 12 (9%) participants

    • Dyspnoea exacerbated: 16 participants

    • Pharyngitis: LAMA 22 (18%) participants; placebo 38 (30%) participants

Most were mild (72 participants, 29%) or moderate (47 participants, 19%)

Concerning drug‐related AEs: LAMA 1 (1%) participant; placebo 4 participants

SAE: 5 participants (2%) in screening period, 1 died

  • LAMA 6 (5%) participants; placebo 4 (3%) participants

  • "One SAE (depression) was considered drug‐related in the placebo arm"

NCT01351792

ICS (beclomethasone) with LABA (formoterol) vs. ICS (budesonide) with LABA (formoterol)

TEAEs: beclomethasone with formoterol 18 events in 10 participants (33%); budesonide with formoterol 32 events in 15 participants (52%), 1 AECOPD (only severe event)

Adverse drug reactions: beclomethasone with formoterol 5 events in 3 participants (10%); budesonide with formoterol 3 events in 3 participants (10%)

AEs leading to study discontinuation: beclomethasone with formoterol 3 events in 3 participants (10%); budesonide with formoterol 5 events in 3 participants (10%)

"No relevant differences between groups were observed in the proportion of patients with TEAEs, SAEs, adverse drug reactions, severe AEs and AEs leading to discontinuation"

Nguyen 2009

Physical activity counselling with pedometer vs. pedometer

AEs: Physical activity counselling with pedometer "greater number (of AEs)... two falls and three AECOPD" (9 participants)

Nolan 2017

Physical activity counselling with PR vs. PR

  • 1 participant not randomised after allergic reaction to nickel baseplate of accelerometer

  • Deaths: Physical activity counselling with PR 2 deaths in 56 participants; PR 2 deaths in 57 participants

  • Hospital admissions: Physical activity counselling with PR 23 admissions; PR 33 admissions; P = 0.50

    • COPD‐related admissions: Physical activity counselling with PR 14 admissions; PR 16 admissions; P = 0.29

O'Neill 2018

Physical activity counselling vs. PR

Study‐related and unexpected AEs; no withdrawals

  • PAC (23 participants): 1 participant heel/toe blister; 1 participant knee swelling; 1 participant nickel reaction (pedometer)

  • PR (27 participants): 1 participant dizziness leaving appointment

Orme 2018

Feedback and education vs. no intervention;

Education vs. no intervention;

Feedback with education vs. education

(post‐admission)

Hospital admissions (at least 1 overnight stay, not study‐related): education 2 admissions in 6 participants (1 respiratory, 1 non‐respiratory)

Hospital re‐admissions for AECOPD (not considered AE, withdrawn from study): education and feedback 3 admissions in 8 participants; no intervention 1 admission in 6 participants

No deaths

Polkey 2018

Tai Chi vs. PR

AEs: "No difference in AEs was observed between the groups" (undefined); Tai Chi 2 events in 60 participants; PR 2 events in 60 participants

Reasons for hospitalisation (SAE) P = 0.769

  • Tai Chi: 3 admissions with AECOPD; 1 admission upper respiratory tract infection, 1 admission stroke, 1 admission difficulty in urine excretion

  • PR: 3 admissions with AECOPD; 1 admission trauma, 1 admission chest pain, 1 admission coronary heart disease, 1 admission oedema of unknown origin

Sandland 2008

Supplemental oxygen vs. placebo (air)

AEs: 1 death during walking test at baseline assessment

Schuz 2015

Self‐management (health mentoring) vs. sham

AEs: self‐management 2 deaths in 47 participants; sham 2 deaths in 73 participants

Respiratory AEs (at least 1 admission for COPD): self‐management 11 (12.2%) participants; sham 5 (5.4%) participants; P = 0.11

Troosters 2014

LAMA (tiotropium) with behavioural management vs. placebo with behavioural management

"No SAEs were considered related to study drug and patients recovered from all events"; no deaths

TEAEs

  • Respiratory (AECOPD, nasopharyngitis, upper respiratory tract infection, cough, bronchitis, influenza, respiratory tract infection, rhinitis, dyspnoea, chronic bronchitis): LAMA 63 events in 238 participants; placebo 53 events in 219 participants; AECOPD "lower incidence in intervention group" OR 0.42 (95% CI 0.21 to 0.84); cough, bronchitis and dyspnoea "lower incidence in intervention group"

  • Musculoskeletal (arthralgia, back pain): LAMA 2 events; placebo 13 events

  • Other (diarrhoea, headache, dry mouth, hypertension, nausea, herpes zoster, hyperglycaemia, epistaxis): LAMA 20 events; placebo 14 events

Troosters 2018

LAMA vs. placebo;

LAMA/LABA vs. placebo;

LAMA/LABA and exercise training vs. placebo;

LAMA/LABA vs. LAMA;

LAMA/LABA and exercise training vs. LAMA;

LAMA/LABA and exercise training vs. LAMA/LABA

N.B. all groups received behavioural modification

Any AE: placebo 46 events in 60 participants; LAMA 51 events in 76 participants; LAMA/LABA 44 events in 76 participants; LAMA/LABA and exercise training 49 events in 76 participants

TEAE: placebo 4 events; LAMA 6 events; LAMA/LABA 3 events; LAMA/LABA and exercise training 2 events

Severe AE: placebo 5 events; LAMA 10 events; LAMA/LABA 3 events LAMA/LABA and exercise training 8 events

"Specific AEs with incidence > 2%"

  • Respiratory ("COPD", dyspnoea, cough, infections and infestations, nasopharyngitis, pneumonia, bronchitis): placebo 46 events; LAMA 53 events; LAMA/LABA 37 events; LAMA/LABA and exercise training 50 events

  • Musculoskeletal disorders, back pain: placebo 16 events; LAMA 9 events; LAMA/LABA 12 events; LAMA/LABA and exercise training 9 events

  • Other (gastrointestinal disorders, nervous system disorders, headache, vascular disorders, hypertension): placebo 17 events; LAMA 15 events; LAMA/LABA 20 events; LAMA/LABA and exercise training 16 events

Vasilopoulou 2017

Maintenance (telerehabilitation) vs. no intervention;

Maintenance (centre‐based) vs. no intervention;

Maintenance (telerehabilitation) vs. maintenance (centre‐based)

AEs: none reported

Wan 2017

Physical activity counselling with pedometer vs. pedometer

SAEs (not study‐related: abdominal pain, anxiety, mental health crisis, headache, congestion, ear pain, rash, skin abscess, kidney problems, toe fracture, car accident): Physical activity counselling with pedometer 14 events in 9 of 57 participants; pedometer 10 events in 8 of 52 participants; P = 0.54

Respiratory AEs: Physical activity counselling with pedometer 15 events in 13 participants; pedometer 9 events in 8 participants; P = 0.29

Watz 2016

LAMA/LABA vs. placebo

All TEAEs: LAMA/LABA 73 events in 44 of 193 participants (4 participants discontinued); placebo 48 events in 43 of 188 participants (2 participants discontinued)

Suspected‐related TEAEs: LAMA/LABA 12 events in 11 participants; placebo 4 events in 4 participants

  • "The only suspected related TEAE to occur in more than one patient in either group was cough" LAMA/LABA 5 (2.6%) participants, placebo 1 (0.5%) participant

Serious TEAEs: LAMA/LABA 4 participants, 1 death (not study‐related: suspected myocardial infarction); placebo 2 participants

Watz 2017

LAMA/LABA vs. placebo

TEAEs: LAMA/LABA 42.5%, placebo 45.1%

SAEs leading to discontinuation: LAMA/LABA 1.5%, placebo 2.3%

AEs leading to discontinuation: LAMA/LABA 3%, placebo 4.5%

Events reported by > 5% of participants: nasopharyngitis (LAMA/LABA 10.4%; placebo 9.8%), headache (LAMA/LABA 3.0%; placebo 9.0%)

Wootton 2017

Exercise training (ground‐based walking) vs. no intervention

AEs: none reported

Physical activity counselling with pedometer vs. no intervention (following ground‐based walking)

"No AEs were reported during the study"

ACE: angiotensin‐converting enzyme; AE: adverse event; AECOPD: acute exacerbation of COPD; COPD: chronic obstructive pulmonary disease; ICS: inhaled corticosteroid; LABA: long‐acting beta2‐agonist; LAMA: long‐acting muscarinic antagonist; n: number; NMES: neuromuscular electrical stimulation; OR: odds ratio; PR: pulmonary rehabilitation; SAE: serious adverse event; SPACE: self‐management programme of activity, coping and education; TEAE: treatment‐emergent adverse event

Figuras y tablas -
Table 6. Adverse events
Comparison 1. Physical activity: intervention vs. no intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in step count (steps per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 End intervention

3

180

Mean Difference (IV, Random, 95% CI)

208.24 [‐164.91, 581.39]

2 time/change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 End intervention

3

190

Mean Difference (IV, Random, 95% CI)

3.62 [‐1.90, 9.14]

3 change in time in light‐intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 End intervention

3

182

Mean Difference (IV, Random, 95% CI)

‐1.87 [‐28.35, 24.61]

4 change in total energy expenditure (kcal); Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 End intervention

2

144

Mean Difference (IV, Random, 95% CI)

‐41.54 [‐89.97, 6.90]

5 change in time in physical activity (total; minutes per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 End intervention

2

88

Mean Difference (IV, Random, 95% CI)

23.01 [6.12, 39.90]

6 change in sedentary time (minutes per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

6.1 End intervention

2

137

Mean Difference (IV, Random, 95% CI)

16.56 [‐27.06, 60.18]

7 time in "lifestyle" physical activity (minutes per day); Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

7.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

9.40 [3.87, 14.93]

8 time in light‐intensity physical activity (minutes per day); Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

8.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

28.12 [15.64, 40.60]

9 time in moderate‐to‐vigorous intensity physical activity (minutes per day); Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

9.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

6.24 [4.00, 8.48]

10 sedentary time (minutes per day); Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

10.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

‐34.25 [‐55.90, ‐12.60]

11 step count (steps per day); Intervention: physical activity counselling Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

11.1 Step count: in‐person (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11.2 Change in step count: telecoaching (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11.3 Step count: 'Urban Training' (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12 "IMA" (counts per minute); Intervention: self‐management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

12.1 Mid‐intervention (4 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.2 Mid‐intervention (12 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 physical activity level; Intervention: nutritional supplement Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

13.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 total energy expenditure (MJ); Intervention: nutritional supplement Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

14.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 subgroup analysis (supervised vs. unsupervised); change in step count (steps per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

15.1 Supervised pulmonary rehabilitation/exercise training

2

144

Mean Difference (IV, Random, 95% CI)

68.86 [‐386.29, 524.01]

15.2 Unsupervised pulmonary rehabilitation/exercise training

1

36

Mean Difference (IV, Random, 95% CI)

494.0 [‐157.70, 1145.70]

16 supgroup analysis (supervised vs. unsupervised); change in time in light‐intensity physical activity (minutes per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

16.1 Supervised pulmonary rehabilitation/exercise training

2

146

Mean Difference (IV, Random, 95% CI)

9.87 [‐9.22, 28.96]

16.2 Unupervised pulmonary rehabilitation/exercise training

1

36

Mean Difference (IV, Random, 95% CI)

‐44.0 [‐87.04, ‐0.96]

17 subgroup analysis (supervised vs. unsupervised); change in total energy expenditure (kcal); Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Totals not selected

17.1 Supervised pulmonary rehabilitation/exercise training

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.2 Unsupervised pulmonary rehabilitation/exercise training

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18 subgroup analysis (supervised vs. unsupervised); change in sedentary time (minutes per day); Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Totals not selected

18.1 Supervised pulmonary rehabilitation/exercise training

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18.2 Unsupervised pulmonary rehabilitation/exercise training

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 1. Physical activity: intervention vs. no intervention
Comparison 2. Physical activity: intervention vs. placebo/sham

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 step count (steps per day); Intervention: self‐management (health mentoring) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in step count (steps per day); Intervention: LAMA/LABA Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 End intervention

2

426

Mean Difference (IV, Random, 95% CI)

531.30 [167.10, 895.49]

3 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day): Intervention: LAMA/LABA Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 End intervention

2

423

Mean Difference (IV, Random, 95% CI)

9.74 [4.23, 15.24]

4 change in active energy expenditure (kcal); Intervention: LAMA/LABA Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 End intervention

2

423

Mean Difference (IV, Random, 95% CI)

43.89 [17.92, 69.86]

5 step count (steps per day); Intervention: nutritional supplement Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

5.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 energy expenditure for ambulation (kcal/step/FFM kg); Intervention: nutritional supplement Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

6.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 change in step count (steps per day); Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

7.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 change in up/down transitions (number); Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

8.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9 change in time upright (hours); Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

9.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 2. Physical activity: intervention vs. placebo/sham
Comparison 3. Physical activity: intervention with common intervention vs. common intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 movement intensity (m/s2); Interventions: nordic walking with education vs. education Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Follow‐up (6 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Follow‐up (9 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in step count (steps per day); Interventions: exercise training (COPE‐active) with self‐management vs. self management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Follow‐up (18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Follow‐up (24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in time in light‐intensity physical activity (minutes per day); Interventions: upper body resistance training with health education vs. health education Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 step count (steps per day); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 time walking (minutes per day); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

5.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 walking intensity (m/s2); Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

6.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 step count (steps per day); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

7.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 time walking (minutes per day); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

8.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9 walking intensity (m/s2); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

9.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10 step count (steps per day); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

10.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11 time walking (minutes per day); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

11.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12 walking intensity (m/s2); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

12.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 change in step count (steps per day); Interventions: exercise training and physical activity counselling with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

13.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 Follow‐up (3 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.3 Follow‐up (12 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 change in step count (weekday, steps per day); Interventions: physical activity counselling with optional supervised exercise vs. optional supervised exercise Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

14.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.3 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 METs; Interventions: physical activity counselling with optional supervised exercise vs. optional supervised exercise Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

15.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.3 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16 step count (steps per day); Interventions: physical activity counselling with pedometer vs. pedometer Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Totals not selected

16.1 Step count: web‐based (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.2 Step count: app (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.3 Step count: app (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.4 Change in step count: web‐based (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.5 Change in step count: web‐based (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17 time active (minutes per day); Interventions: physical activity counselling (app) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

17.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18 time inactive (minutes per day); Interventions: physical activity counselling (app) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

18.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19 peak performance (steps per minute); Interventions: physical activity counselling (app) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

19.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20 step count (steps per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Totals not selected

20.1 End intervention (7 days including PR)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.2 End intervention (6 days excluding PR)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.3 End intervention (4 days excluding PR)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.4 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.5 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21 time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

21.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22 time in physical activity (total, minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

22.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

23 time sedentary (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

23.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

23.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

24 change in step count (steps per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

24.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

24.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

25 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

25.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

25.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26 change in time walking (minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

26.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27 change in time in physical activity (total, minutes per day); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

27.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

28 change in time in light‐intensity physical activity (minutes per day); Interventions: exercise‐specific self‐efficacy training with upper body resistance training vs. upper body resistance training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

28.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

28.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

29 step count (steps per day); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

29.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

29.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

30 time walking (minutes per day); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

30.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

30.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

31 walking intensity (m/s2); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

31.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

31.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

32 step count (steps per day); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

32.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

32.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

33 time walking (minutes per day); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

33.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

33.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

34 walking intensity (m/s2); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

34.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

34.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

35 step count (steps per day); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

35.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

35.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

36 time walking (minutes per day); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

36.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

36.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

37 walking intensity (m/s2); Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

37.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

37.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

38 change in step count (steps per day); Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

38.1 End intervention (stage 1)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

38.2 End intervention (stage 2)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

38.3 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

39 change in step count (steps per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

39.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

39.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

40 change in time in moderate‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

40.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

40.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

41 change in time in vigorous‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

41.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

41.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

42 change in time in light‐intensity physical activity (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

42.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

42.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

43 change in total energy expenditure (kcal); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

43.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

43.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

44 change in sedentary time (minutes per day); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

44.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

44.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 3. Physical activity: intervention with common intervention vs. common intervention
Comparison 4. Physical activity: intervention vs. intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in step count (steps per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in time in moderate‐to‐vigorous intensity physical activity (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in number of bouts of moderate‐to‐vigorous intensity physical activity; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 change in time in bouts of moderate‐to‐vigorous intensity physical activity(minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 change in sedentary time (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

5.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 change in sedentary time (awake; minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

6.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 change in number of sedentary bouts; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

7.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 change in time in sedentary bouts (minutes per day); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

8.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9 change in METs; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

9.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10 change in total energy expenditure (kcal); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

10.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11 change in step count (steps per day); Interventions: water‐based exercise training vs. land‐based exercise training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

11.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12 change in total energy expenditure (kcal); Interventions: water‐based exercise training vs. land‐based exercise training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

12.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 step count (steps per day); Interventions: Tai Chi vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

13.1 Mid‐intervention (6 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 Mid‐intervention (22 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 step count (steps per day); Interventions: outdoor walking vs. cycle ergometry Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

14.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 step count (steps per day); Interventions: physical activity counselling vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

15.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16 total energy expenditure (kcal); Interventions: exercise training with tapered supervision vs. supervised exercise training Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

16.1 End intervention

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.2 Follow‐up

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

17 mid day activity (vector magnitude units per minute); Interventions: supplemental oxygen (lightweight ambulatory) vs. supplemental oxygen (E‐cylinder) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

17.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 4. Physical activity: intervention vs. intervention
Comparison 5. Health‐related quality of life: intervention vs. no intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in SGRQ total score; Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 End intervention

2

144

Mean Difference (IV, Random, 95% CI)

‐8.79 [‐14.08, ‐3.51]

2 change in SGRQ domain scores. Intervention: pulmonary rehabilitation/exercise training (ground‐based walking) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in CRQ domain scores; Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Dyspnoea (end intervention)

3

182

Mean Difference (IV, Random, 95% CI)

1.69 [0.02, 3.36]

3.2 Emotional function (end intervention)

3

182

Mean Difference (IV, Random, 95% CI)

2.41 [0.48, 4.35]

3.3 Fatigue (end intervention)

3

182

Mean Difference (IV, Random, 95% CI)

1.34 [‐0.16, 2.83]

3.4 Mastery (end intervention)

3

182

Mean Difference (IV, Random, 95% CI)

0.61 [‐0.47, 1.69]

3.5 Total score (end intervention)

3

182

Mean Difference (IV, Random, 95% CI)

6.70 [2.55, 10.86]

4 CAT score; Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

‐3.15 [‐4.82, ‐1.47]

5 SGRQ domain scores (%change); Intervention: exercise training [inpatient] Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

5.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.4 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.5 Symptoms (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.6 Activity (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.7 Impacts (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.8 Total score (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 SGRQ domain scores; Intervention: physical activity counselling Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

6.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.4 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 CCQ domain scores: Intervention: physical activity counselling Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

7.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Functional state (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Mental state (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.4 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 change in CCQ domain scores; Intervention: physical activity counselling (telecoaching) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

8.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Functional state (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Mental state (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9 change in CRQ domain and total scores; Intervention: physical activity counselling Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

9.1 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.5 Total (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10 change in SGRQ domain and total scores; Intervention: physical activity counselling Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

10.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Total (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11 change in CRQ domain scores; Intervention: self‐management (SPACE) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

11.1 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.2 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.5 Dyspnoea (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.6 Emotional domain (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.7 Fatigue (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.8 Mastery (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12 CCQ total score; Intervention: self‐management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

12.1 Mid‐intervention (4 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.2 Mid‐intervention (12 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 EQ5D index score; Intervention: self‐management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

13.1 Mid‐intervention (4 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 Mid‐intervention (12 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 EQ5D visual analogue scale score; Intervention: self‐management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

14.1 Mid‐intervention (4 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 Mid‐intervention (12 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 SGRQ domain scores; Intervention: self‐management (telephone health coaching) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

15.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.4 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.5 Symptoms (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.6 Activity (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.7 Impacts (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.8 Total score (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16 EQ5D score; Intervention: self‐management (telephone health coaching) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

16.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17 CRQ domain scores; Intervention: four‐wheeled walker Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

17.1 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.2 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 5. Health‐related quality of life: intervention vs. no intervention
Comparison 6. Health‐related quality of life: intervention vs. placebo/sham

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in SF36 component scores; Intervention: singing Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 Physical component (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Mental component (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in CRQ total score; Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in SGRQ total score; Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 change in EQ5D index score; Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 change in EQ5D visual analogue scale score; Intervention: neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

5.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 6. Health‐related quality of life: intervention vs. placebo/sham
Comparison 7. Health‐related quality of life: intervention with common intervention vs. common intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 SF36 component scores (score < 50); Interventions: Nordic walking with education vs. education Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 Physical component score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Physical component score (follow‐up, 6 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Physical component score (follow‐up, 9 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Mental component score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.5 Mental component score (follow‐up, 6 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.6 Mental component score (follow‐up, 9 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in CRQ domain scores; Interventions: exercise training (COPE‐active) with self‐management vs. self management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.6 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.9 Dyspnoea (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.10 Emotional function (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.11 Fatigue (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.12 Mastery (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.13 Dyspnoea (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.14 Emotional function (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.15 Fatigue (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.16 Mastery (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in CCQ domain scores; Interventions: exercise training (COPE‐active) with self‐management vs. self management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 Symptoms (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Functional state (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Mental state (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Total (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Functional state (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.7 Mental state (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Total (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Symptoms (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Functional state (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.11 Mental state (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.12 Total (follow‐up, 18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.13 Symptoms (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.14 Functional state (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.15 Mental state (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.16 Total (follow‐up, 24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 CRQ domain scores; Interventions: LAMA/LABA and exercise training with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 CRQ domain scores; Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

5.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.3 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.6 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 CRQ domain scores; Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

6.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.6 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 change in SGRQ domain and total scores; Intervention: exercise training and physical activity counselling with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

7.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.4 Total (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.5 Symptoms (follow‐up, 3 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.6 Activity (follow‐up, 3 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.7 Impacts (follow‐up, 3 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.8 Total (follow‐up, 3 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.9 Symptoms (follow‐up, 12 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.10 Activity (follow‐up, 12 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.11 Impacts (follow‐up, 12 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.12 Total (follow‐up, 12 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 change in CRQ domain scores; Interventions: physical activity counselling (app) with optional supervised exercise vs. optional supervised exercise Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

8.1 Dyspnoea (12 weeks, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Emotional function (12 weeks, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Fatigue (12 weeks, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.4 Mastery (12 weeks, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.5 Dyspnoea (6 months, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.6 Emotional function (6 months, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.7 Fatigue (6 months, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.8 Mastery (6 months, mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.9 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.10 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.11 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.12 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9 change in SGRQ total score; Interventions: physical activity counselling with pedometer vs. pedometer Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Totals not selected

9.1 web‐based (12 weeks, end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 web‐based (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.3 web‐based (12 months, end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10 SGRQ total: Interventions: physical activity counselling (app) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

10.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11 SF36: Interventions: physical activity counselling (app) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

11.1 Physical component score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.2 Mental component score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12 change in SGRQ domain scores; Interventions: physical activity counselling (web‐based) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

12.1 Symptoms (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.2 Impacts (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.3 Activities (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.4 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.5 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.6 Activities (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 SGRQ domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

13.1 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.3 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 RAND36 domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

14.1 Physical function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 Vitality (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.3 Bodily pain (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.4 General health perception (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.5 Health status (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 change in CRQ dyspnoea domain score; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

15.1 Mid‐intervention (end PR)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16 SGRQ scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

16.1 Symptoms (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.2 Activity (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.3 Impacts (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.4 Total score (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.5 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.6 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.7 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.8 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17 CRQ domain scores; Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

17.1 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.2 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.5 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18 change in CRQ total score; Interventions: physical activity counselling with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

18.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19 change in CRQ scores; Interventions: self‐management (health coaching) with pulmonary rehabilitation referral vs. pulmonary rehabilitation referral Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

19.1 Physical function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19.2 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19.3 Physical function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19.4 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20 CRQ domain scores; Interventions: LAMA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

20.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.2 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.3 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.6 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21 CRQ domain scores; Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

21.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.2 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.3 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.6 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22 CRQ domain scores; Interventions: LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

22.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.2 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.3 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.5 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.6 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.8 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

23 change in SGRQ domain and total scores; Interventions: ACE inhibitor with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

23.1 Symptoms (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

23.2 Activity (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

23.3 Impacts (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

23.4 Total (end intervention)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

24 change in SGRQ total score; Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

24.1 End intervention (stage 2)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

24.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

25 change in EQ5D; Interventions: nutritional supplement with pulmonary rehabilitation vs. placebo with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

25.1 End intervention (stage 2)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

25.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26 change in CRQ domain scores; Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

26.1 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.2 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.5 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.6 Dyspnoea (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.7 Emotional function (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.8 Fatigue (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.9 Mastery (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

26.10 Total score (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27 CRQ domain scores; Interventions: non‐invasive ventilation with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

27.1 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27.2 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

27.5 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 7. Health‐related quality of life: intervention with common intervention vs. common intervention
Comparison 8. Exercise capacity: intervention vs. placebo/sham

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in 6MWD (metres); Intervention; neuromuscular electrical stimulation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 8. Exercise capacity: intervention vs. placebo/sham
Comparison 9. Exercise capacity: intervention vs. no intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in 6MWD (metres); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 End intervention

3

182

Mean Difference (IV, Random, 95% CI)

29.06 [14.38, 43.75]

2 change in ISWD (metres); Intervention: pulmonary rehabilitation/exercise training Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 End intervention

3

180

Mean Difference (IV, Random, 95% CI)

19.02 [2.20, 35.85]

3 change in ESWT (seconds); Intervention: pulmonary rehabilitation/exercise training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 End intervention

2

137

Mean Difference (IV, Random, 95% CI)

237.87 [147.59, 328.16]

4 6MWD (metres); Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

46.55 [24.66, 68.45]

5 work rate (watts); Intervention: high‐intensity interval training Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 End intervention

2

275

Mean Difference (IV, Random, 95% CI)

15.47 [8.76, 22.17]

6 change in ISWD (metres); Intervention: self‐management (SPACE) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

6.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 change in ESWT (seconds); Intervention: self‐management (SPACE) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

7.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 6MWD (metres); Intervention: exercise training [inpatient] Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

8.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 9. Exercise capacity: intervention vs. no intervention
Comparison 10. Health‐related quality of life: intervention vs. intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in CRQ domains; Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.5 Dyspnoea (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.6 Emotional function (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.7 Fatigue (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.8 Mastery (follow‐up)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in CRQ domains; Interventions: water‐based exercise training vs. land‐based exercise training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 Dyspnoea (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Emotional function (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Fatigue (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Mastery (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.5 Total score (mid‐intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.6 Dyspnoea (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Emotional function (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.8 Fatigue (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.9 Mastery (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.10 Total score (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 SGRQ domain and total scores; Interventions: Tai Chi vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 Symptoms (mid‐intervention, 2 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Activity (mid‐intervention, 2 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Impacts (mid‐intervention, 2 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Total (mid‐intervention, 2 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Symptoms (mid‐intervention, 14 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Activity (mid‐intervention, 14 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.7 Impacts (mid‐intervention, 14 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Total (mid‐intervention, 14 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Symptoms (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Activity (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.11 Impacts (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.12 Total (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 CRQ total score; Interventions: outdoor walking vs. cycle ergometry Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Maugeri Respiratory Failure questionnaire; Interventions: exercise training with tapered supervision vs. supervised exercise training Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5.1 End intervention

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 Follow‐up

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 SF36 domain scores; Interventions: self‐management vs. education and symptom monitoring Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

6.1 Mental health (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Role emotional (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Vitality (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.4 Social functioning (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.5 Pain (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.6 Role physical (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.7 General health (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.8 Physical functioning (end intervention)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 10. Health‐related quality of life: intervention vs. intervention
Comparison 11. Exercise capacity: intervention with common intervention vs. common intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 6MWD (metres); Interventions: Nordic walking with education vs. education Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Follow‐up (6 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Follow‐up (9 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in ISWD (metres); Interventions: exercise training (COPE‐active) with self‐management vs. self management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Follow‐up (18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Follow‐up (24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in ESWT (seconds); Interventions: exercise training (COPE‐active) with self‐management vs. self management Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Follow‐up (18 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Follow‐up (24 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 6MWD (metres); Interventions: exercise training and LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 ESWT (seconds); Interventions: exercise training and LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

5.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 6MWD (metres); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

6.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 ESWT (seconds); Interventions: exercise training and LABA with LAMA and behaviour modification vs. LAMA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

7.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8 6MWD (metres); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

8.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9 ESWT (seconds); Interventions: exercise training with LAMA/LABA and behaviour modification vs. LAMA/LABA and behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

9.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10 change in ESWT (seconds); Intervention: physical activity counselling and exercise training with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

10.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Follow‐up (3 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Follow‐up (12 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11 6MWD (metres); Interventions: physical activity counselling (app) with optional supervised exercise vs. optional supervised exercise Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

11.1 Mid‐intervention (12 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.2 Mid‐intervention (6 months)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

11.3 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12 6MWD (metres); Interventions: physical activity counselling (app) with pedometer vs. pedometer Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

12.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

12.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 6MWD (metres); Interventions: physical activity counselling with pulmonary rehabilitation vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

13.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 change in 6MWD (metres); Interventions: physical activity counselling with pulmonary rehabilitation vs. sham with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

14.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 6MWD (metres); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

15.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16 ESWT (seconds); Interventions: LAMA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

16.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

16.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17 6MWD (metres); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

17.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

17.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18 ESWT (s); Interventions: LAMA/LABA with behaviour modification vs. placebo with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

18.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

18.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19 6MWD (metres); Interventions: LAMA/LABA with behaviour modification vs. LAMA with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

19.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

19.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20 ESWT (seconds); Interventions: LAMA/LABA with behaviour modification vs. LAMA with behaviour modification Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

20.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

20.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21 change in ISWD (metres); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

21.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

21.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22 change in ESWT (seconds); Interventions: supplemental oxygen with pulmonary rehabilitation vs. sham intervention with pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

22.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

22.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 11. Exercise capacity: intervention with common intervention vs. common intervention
Comparison 12. Exercise capacity: intervention vs. intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 change in 6MWD (metres); Interventions: home‐based pulmonary rehabilitation vs. centre‐based pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 change in 6MWD (metres); Interventions: water‐based exercise training vs. land‐based exercise training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 change in ISWD (metres); Interventions: water‐based exercise training vs. land‐based exercise training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 change in VO2max (ml/min); Interventions: water‐based exercise training vs. land‐based exercise training Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 Mid‐intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 6MWD (metres); Interventions: Tai Chi vs. pulmonary rehabilitation Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

5.1 Mid‐intervention (2 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Mid‐intervention (14 weeks)

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.3 End intervention

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 6MWD (metres); Interventions: exercise training with tapered supervision vs. supervised exercise training Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6.1 End intervention

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Follow‐up

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 12. Exercise capacity: intervention vs. intervention