Respiratory muscle training for cystic fibrosis

Gemma Stanford; Harrigan Ryan; Arturo Solis-Moya

doi:10.1002/14651858.CD006112.pub5

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Comparison 1: RMT (80% of maximal effort) versus control, Outcome 1: FEV1 (L)

Analysis 1.1

Comparison 1: RMT (80% of maximal effort) versus control, Outcome 1: FEV₁ (L)

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Analysis 1.2

Comparison 1: RMT (80% of maximal effort) versus control, Outcome 2: FVC (L)

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Analysis 1.3

Comparison 1: RMT (80% of maximal effort) versus control, Outcome 3: Chronic Respiratory Disease Questionnaire (mastery)

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Analysis 1.4

Comparison 1: RMT (80% of maximal effort) versus control, Outcome 4: Chronic Respiratory Disease Questionnaire (emotion)

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Comparison 2: RMT (60% of maximal effort) versus control, Outcome 1: FEV1 (L)

Analysis 2.1

Comparison 2: RMT (60% of maximal effort) versus control, Outcome 1: FEV₁ (L)

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Analysis 2.2

Comparison 2: RMT (60% of maximal effort) versus control, Outcome 2: PImax (cm H₂O)

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Comparison 3: RMT (40% of maximal effort) versus control, Outcome 1: FEV1 (L)

Analysis 3.1

Comparison 3: RMT (40% of maximal effort) versus control, Outcome 1: FEV₁ (L)

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Comparison 3: RMT (40% of maximal effort) versus control, Outcome 2: FEV1 (% predicted)

Analysis 3.2

Comparison 3: RMT (40% of maximal effort) versus control, Outcome 2: FEV₁ (% predicted)

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Analysis 3.3

Comparison 3: RMT (40% of maximal effort) versus control, Outcome 3: FVC (L)

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Analysis 3.4

Comparison 3: RMT (40% of maximal effort) versus control, Outcome 4: FVC (% predicted)

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Analysis 3.5

Comparison 3: RMT (40% of maximal effort) versus control, Outcome 5: Inspiratory muscle endurance (% PImax)

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Comparison 4: RMT (30% of maximal effort) versus control, Outcome 1: FEV1 (% predicted) absolute

Analysis 4.1

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 1: FEV₁ (% predicted) absolute

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Comparison 4: RMT (30% of maximal effort) versus control, Outcome 2: FEV1 (% predicted) change from baseline

Analysis 4.2

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 2: FEV₁ (% predicted) change from baseline

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Analysis 4.3

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 3: FVC (%) absolute

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Analysis 4.4

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 4: FVC (%) change from baseline

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Analysis 4.5

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 5: Peak expiratory flow (%) absolute

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Analysis 4.6

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 6: Peak expiratory flow (%) change from baseline

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Analysis 4.7

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 7: Six‐minute walk test absolute

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Analysis 4.8

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 8: Six‐minute walk test change from baseline

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Analysis 4.9

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 9: Maximal inspiratory pressure (PI_max) absolute

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Analysis 4.10

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 10: Maximal inspiratory pressure (PI_max) change from baseline

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Analysis 4.11

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 11: Maximal expiratory pressure (PE_max) absolute

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Analysis 4.12

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 12: Maximal expiratory pressure (PE_max) change from baseline

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Analysis 4.13

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 13: Adherence

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Analysis 4.14

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 14: Resting oxygen saturations absolute

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Analysis 4.15

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 15: Resting oxygen saturations change from baseline

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Analysis 4.16

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 16: Oxygen saturation change during test (absolute)

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Analysis 4.17

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 17: Oxygen saturation change during test (change from baseline)

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Analysis 4.18

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 18: Postural stability test absolute values after treatment (8 weeks)

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Analysis 4.19

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 19: Postural stability test change from baseline (8 weeks)

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Analysis 4.20

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 20: Limits of stability test absolute values after treatment (8 weeks)

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Analysis 4.21

Comparison 4: RMT (30% of maximal effort) versus control, Outcome 21: Limits of stability test change from baseline (8 weeks)

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Comparison 5: RMT (20% of maximal effort) versus control, Outcome 1: FEV1 (L)

Analysis 5.1

Comparison 5: RMT (20% of maximal effort) versus control, Outcome 1: FEV₁ (L)

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Analysis 5.2

Comparison 5: RMT (20% of maximal effort) versus control, Outcome 2: FVC (L)

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Summary of findings 1. Summary of findings: respiratory muscle training compared with control for cystic fibrosis

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
Respiratory muscle training compared with control for cystic fibrosis
Patient or population: adults and children with cystic fibrosis Settings: outpatients Intervention: respiratory muscle training^a Comparison: control^a
	Assumed risk	Corresponding risk
	Control	Respiratory muscle training
FEV₁ % predicted Follow‐up: 1 ‐ 3 months	No study reported any differences between the respiratory muscle training group and the control group.		NA	83 (4)	⊕⊝⊝⊝ very low^b,c	1 study reported data for FEV₁ % predicted at 40% of maximal capacity (de Jong 2001). 2 studies reported FEV₁ % predicted at 30% of maximal capacity (Amelina 2006; Zeren 2019). 1 study reported FEV₁ % predicted, but did not specify the resistance used (Asher 1983). 3 studies reported FEV₁ measured in L and 1 measured z score; 1 study did not report the units of measurement. Results were similar to those for FEV₁ % predicted.
FVC: % predicted Follow‐up: 1 ‐ 3 months	No study reported any differences between the respiratory muscle training group and the control group.		NA	72 (3)	⊕⊝⊝⊝ very low^b,c	1 study reported data for analysis for FVC (% predicted) at 40% of maximal capacity (de Jong 2001) and two studies at 30% of maximal capacity (Amelina 2006; Zeren 2019). 2 studies reported FVC in L and 1 measured z score; 1 study did not report the units of measurement. Results were similar to those for FVC % predicted.
Exercise capacity: VO_2max (mL/kg/min) Follow‐up: 1 ‐ 3 months	No study reported any differences between the respiratory muscle training group and the control group.		NA	54 (3 studies including 1 cross‐over study)	⊕⊝⊝⊝ very low^b,c	One study with an unspecified level of resistance reported an improvement within the respiratory muscle training group.
HRQoL: total score Follow‐up: 1 ‐ 3 months	2 studies reported no differences between the respiratory muscle training group and the control group. 1 study reported improvements in the parameters of mastery and emotion in the respiratory muscle training group compared to the control group.		NA	69 (3 studies including 1 cross‐over study)	⊕⊝⊝⊝ very low^b,c	2 studies used the Chronic Respiratory Disease Questionnaire (CRDQ) and 1 study used the cystic fibrosis questionnaire (CFQ).
Respiratory muscle function: maximal inspiratory pressure (PI_max) Follow‐up: 1 ‐ 3 months	There was a greater improvement in the respiratory muscle training groups in 2 of the 4 studies measuring this outcome: MD 26.00 (95% CI 8.63 to 43.47) (Sawyer 1993); and MD 14.63 (95% CI 5.63 to 23.63) (Zeren 2019). The remaining 2 studies reported no differences between the respiratory muscle training group and the control group (Amelina 2006; Asher 1983).		NA	87 (4 studies including 1 cross‐over study)	⊕⊝⊝⊝ very low^b,c	Of the studies reporting a difference, the Sawyer study measured at 60% of maximal effort (Sawyer 1993) and the Zeren study measured at 30% resistance (Zeren 2019). 1 of the remaining studies reported at 30% of maximal effort (Amelina 2006) and 1 did not specify the level of resistance (Asher 1983).
Respiratory muscle function: inspiratory capacity Follow‐up: 1 ‐ 3 months	No studies reported this outcome.				NA
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; FEV₁ : forced expiratory volume in 1 second; FVC: forced vital capacity; HRQoL: health related quality of life;NA: not applicable; VO₂_max : maximal oxygen uptake.
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.
a. The resistance level of the respiratory muscle training intervention was variable; three studies used 80% of maximal effort, one study used 60% of maximal effort, one study used 40% of maximal effort, one study used 30% of maximal effort and three studies did not specify the level of resistance. Control groups were also variable; cycle ergometer, H₂0, treatment as usual, standard chest physiotherapy, low resistance threshold loading device, no training or sham training. b. Downgraded twice due to serious risk of bias: the included studies lacked methodological detail relating to methods of randomisation, allocation concealment and blinding. Most of the studies were at high risk of bias due to lack of blinding, incomplete outcome data or selective reporting, or both. c. Downgraded due to imprecision: studies included a small number of participants and numerical results were not available for some of the studies.

Summary of findings 1. Summary of findings: respiratory muscle training compared with control for cystic fibrosis

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Comparison 1. RMT (80% of maximal effort) versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 FEV₁ (L) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.1.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.2 FVC (L) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.2.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.3 Chronic Respiratory Disease Questionnaire (mastery) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.3.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.4 Chronic Respiratory Disease Questionnaire (emotion) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.4.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 1. RMT (80% of maximal effort) versus control

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Comparison 2. RMT (60% of maximal effort) versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 FEV₁ (L) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

2.1.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
2.2 PImax (cm H₂O) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

2.2.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 2. RMT (60% of maximal effort) versus control

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Comparison 3. RMT (40% of maximal effort) versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 FEV₁ (L) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.1.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
3.2 FEV₁ (% predicted) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.2.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
3.3 FVC (L) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.3.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
3.4 FVC (% predicted) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.4.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
3.5 Inspiratory muscle endurance (% PImax) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.5.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 3. RMT (40% of maximal effort) versus control

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Comparison 4. RMT (30% of maximal effort) versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 FEV₁ (% predicted) absolute Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.1.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.2 FEV₁ (% predicted) change from baseline Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.2.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.3 FVC (%) absolute Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.3.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.4 FVC (%) change from baseline Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.4.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.5 Peak expiratory flow (%) absolute Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.5.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.6 Peak expiratory flow (%) change from baseline Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.6.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.7 Six‐minute walk test absolute Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.7.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.8 Six‐minute walk test change from baseline Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.8.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.9 Maximal inspiratory pressure (PI_max) absolute Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.9.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.10 Maximal inspiratory pressure (PI_max) change from baseline Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.10.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.11 Maximal expiratory pressure (PE_max) absolute Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.11.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.12 Maximal expiratory pressure (PE_max) change from baseline Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.12.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.13 Adherence Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.13.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.14 Resting oxygen saturations absolute Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.14.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.15 Resting oxygen saturations change from baseline Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.15.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.16 Oxygen saturation change during test (absolute) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.16.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.17 Oxygen saturation change during test (change from baseline) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.17.1 Two to six months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.18 Postural stability test absolute values after treatment (8 weeks) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.18.1 Overall score	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.18.2 Anterior/posterior SI	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.18.3 Medial/lateral SI	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.19 Postural stability test change from baseline (8 weeks) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.19.1 Overall score	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.19.2 Anterior/posterior SI	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.19.3 Medial/lateral SI	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.20 Limits of stability test absolute values after treatment (8 weeks) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.20.1 Overall score	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.20.2 Forward DS	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.20.3 Backward DS	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.20.4 Left DS	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.20.5 Right DS	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.21 Limits of stability test change from baseline (8 weeks) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.21.1 Overall score	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.21.2 Forward DS	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.21.3 Backward DS	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.21.4 Left DS	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.21.5 Right DS	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 4. RMT (30% of maximal effort) versus control

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Comparison 5. RMT (20% of maximal effort) versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 FEV₁ (L) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.1.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.2 FVC (L) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.2.1 One to three months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 5. RMT (20% of maximal effort) versus control

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