Methods

Study design: RCT

Study grouping: Parallel group

Participants

Baseline characteristics

Exercise training

• Number enrolled: 10

• Gender (male/female): 0/10

• Age (years): 53 (13)

• Body Mass Index: 30.2 (7)

• Haemodynamics: mPAP (mmHG, RHC): 40.3 (13.8)

• Haemodynamics: PVR (Wood Units, RHC): 508 (293)

• Height (cm):

• Weight (kg):

• Medications (mono/dual/triple): 5/1/4

• NYHA, WHO Functional Class (I/II/III/IV): 1/4/4/1

Control

• Number enrolled: 13

• Gender (male/female): 0/13

• Age (years): 55.5 (8.5)

• Body Mass Index: 31.8 (7.4)

• Haemodynamics: mPAP (mmHG, RHC): 43.8 (14.2)

• Haemodynamics: PVR (Wood Units, RHC): 583 (409)

• Height (cm):

• Weight (kg):

• Medications (mono/dual/triple): 2/5/5 (one had no therapy)

• NYHA, WHO Functional Class (I/II/III/IV): 0/208/5/0

Included criteria: Quote "Patients with World Health Organization (WHO) group 1 PH were recruited from local outpatient clinics and enrolled between September 2009 and October 2011. Men and women were eligible if they were between 21 and 82 years of age, had PH diagnosed by a resting mean pulmonary arterial pressure ≥ 25 mm Hg as measured by right‐sided heart catheterization, were on stable PH therapies for at least 3 months, were sedentary, and had no pulmonary rehabilitation for 6 months prior to enrolment".

Excluded criteria: Quote "To avoid “ceiling” or “floor” effects, patients were excluded if they were classified ed as WHO and New York Heart Association (NYHA) functional class I and could walk 400 m during a 6MWT, or classified as functional class IV and could not walk 50 m during a 6MWT. Additional exclusion criteria included FEV1 /FVC ratio ≤ 65%; history of ischaemic heart disease; ejection fraction < 40%; documented pulmonary capillary wedge pressure ≥ 18 mm Hg; significant hepatic, renal, or mitochondrial dysfunctions; severe psychiatric disease; use of medications that may limit exercise capacity or ability to adapt to exercise training; antiretroviral therapies; illicit drugs; tobacco use; or pregnancy".

Pretreatment: Control group had worse lung function

Interventions

Intervention characteristics

Exercise training

• Setting: outpatient programme

• Components: exercise training and education

• Training dose (frequency number/week): 2‐3 times/week (24‐30 sessions in total, 10‐week programme). Mean number of sessions 28 ± 2

• Training dose (duration ‐ min): 30‐45 min

• Training dose (intensity): quote: "A target exercise intensity of 70% to 80% of each patient’s heart rate (HR) reserve obtained from the baseline CPET was used to guide each exercise session. Target HR range was calculated ....in accordance with the method of Karvonen."

• Training dose (mode): treadmill walking

• Education (total hours): 10, "The education sessions consisted of weekly 1‐hour lectures on anatomy and physiology, lung disease processes, medication use, oxygen therapy, sleep disorders, preventing infection, airway clearance, interpreting pulmonary function tests, energy conservation, panic control, relaxation techniques, breathing retraining, community resources, advance directives, social well being, nutrition, and benefits of exercise."

Control

• Education only

Outcomes

6MWD

VO₂peak

Anaerobic threshold
HRQoL (SF‐36): Physical functioning

HRQoL (SF‐36): Role physical

HRQoL (SF36): Bodily pain

HRQoL (SF‐36): General health

HRQoL (SF‐36): Vitality

HRQoL (SF‐36): Social function

HRQoL (SF‐36): Role emotional

HRQoL (SF‐36): Mental health

HRQoL: Physical summary score (SF‐36)

HRQoL: Mental summary score (SF‐36)

HRQol (CAMPHOR): Symptoms

HRQol (CAMPHOR): Activities

HRQol (CAMPHOR): QoL

NYHA Class

Identification

This work was supported by the US National Institutes of Health (Intramural Funds 1 Z01 CL060068‐05 CC)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Patients who enrolled in the protocol were sequentially assigned subject numbers that randomly corresponded to a group receiving concurrent patient education plus aerobic exercise training (EXE) or to a group that received only the patient education portion of the regimen (EDU)."

Allocation concealment (selection bias)

Unclear risk

Not specified. Quote " Following the baseline evaluations, patients were informed of the group to which they were randomly assigned"

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Quote: "Study personnel were blind to the randomization of patients during all baseline evaluations."

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "Investigators administering the CPET, 6MWT, and questionnaires were blind to randomization at baseline."

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "criterion (Fig. 1). All 29 of these patients performed base‐ line testing. Based on their test responses, two of these patients were required to obtain additional medical clearance prior to beginning the intervention. One patient declined further participation while the other patient was cleared for participation and subsequently assigned a new subject number upon re‐entry into the protocol. This patient was originally assigned a subject number corresponding to EXE, but at re‐entry the randomization procedure resulted re‐assignment to EDU. As such, 28 patients in total participated in either the EXE or EDU groups (Fig. 1). Of the 14 patients allocated to the EXE group, two patients withdrew due to changes in medication and one withdrew due to low attendance at the exercise sessions. One patient in the EDU group was withdrawn from the study due to medication changes."

Selective reporting (reporting bias)

High risk

Comment: Trial protocol at clinicaltrials.gov states that they were also going to collect IPAQ, stages of exercise change, exercise self efficacy, profile of mood states and near infrared spectroscopy

Other bias

Low risk

Methods

Study design: RCT

Study grouping: Parallel group

Participants

Baseline characteristics

Exercise

• Number enrolled: 46

• Gender (male/female): 20/26

• Type of PH: CTEPH n = 11, PAH n = 35

• Haemodynamics: PASP (mmHG, Echo):

• Haemodynamics: CI (L/min/m2, Echo):

• Haemodynamics: mPAP (mmHG, RHC): 41 (11.7)

• Haemodynamics: PVR (Dyne.s/cm5, RHC): 540 (267)

• Age: 55(15)

• Height (cm): 170 (9)

• Weight (kg): 75( 18)

• Medications (single/double/triple): 13/20/6

• NYHA, WHO Functional Class (I/II/III/IV): 0/8/36/0

• B‐type natriuretic peptide (pg/mL): 1163+2520

Control

• Number enrolled: 41

• Gender (male/female): 20/21

• Type of PH: CTEPH n = 15, PAH n = 26

• Haemodynamics: PASP (mmHG, Echo):

• Haemodynamics: CI (L/min/m2, Echo):

• Haemodynamics: mPAP (mmHG, RHC): 37.6(11.8)

• Haemodynamics: PVR (Dyne.s/cm5, RHC): 512(338)

• Age: 57(15)

• Height (cm):171 (8)

• Weight (kg): 79 (18)

• Medications (single/double/triple): 14/22/4

• NYHA, WHO Functional Class (I/II/III/IV): 0/6/30/4

• B‐type natriuretic peptide (pg/mL): 1114+1386

Included criteria: participants with PAH and inoperable or persistent CTEPH and chronic right heart failure who were stable on disease‐targeted medication for at least 2 months prior to inclusion were randomly assigned to a control and a training group. Medication remained unchanged during the study period.

Excluded criteria: not specified

Pretreatment: Nil evident

Interventions

Intervention characteristics

Exercise

• Setting: 3 weeks inpatient training, followed by 12 weeks unsupervised outpatient training at home

• Components: exercise training, mental training, psychological support

• Training ose frequency: inpatient, walking and cycling 7 d/week, resistance exercises and respiratory training 5 d/week. Outpatient, cycling 5 x/week, walk twice a week, respiratory training and resistance ex second daily.

• Intervention (mode): interval bicycle ergometer training, walking, respiratory training, resistance training

• Training dose: duration: 10‐25 min cycle ergometer, 60 min walking, 30 min resistance training, 30 min respiratory training

• Training dose: intensity: cycle ergometer: 60%‐80% of HR on CPET. HR maintained < 120 bpm, oxygen saturation > 85%

Control

• Continued usual lifestyle

Outcomes

6MWD

VO₂peak

W_peak (peak power)

Morbidity ‐ adverse events

Disease Progression

Precluded from Training

HRQoL (SF‐36): Physical functioning

HRQoL (SF‐36): Role physical

HRQoL (SF36): Bodily pain

HRQoL (SF‐36): General health

HRQoL (SF‐36): Vitality

HRQoL (SF‐36): Social function

HRQoL (SF‐36): Role emotional

HRQoL (SF‐36): Mental health

Discontinued training

Haemodynamics ‐ mPAP (mmHg), PVR (Dynes), cardiac output (L/min)

B‐type natriuretic peptide

Identification

Sponsorship Source: funding to pay the open access publication charges for this article was provided by Centre for Pulmonary Hypertension, Thorax clinic at the University of Heidelberg, Germany

Comments Author's contact details Nicola Ehlken University Hospital Heidelberg, [email protected]‐heidelberg.de Amalienstrasse 5, Heidelberg D‐69126, Germany

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Does not specify methods of randomisation

Allocation concealment (selection bias)

Unclear risk

Does not specify whether allocation was concealed

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Not possible to blind participants to intervention

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Quote: "Assessment of 6MWD, SF‐36 and other efficacy parameter were performed by investigators who were blinded to the clinical data"

Not clear whether assessors were blinded to group allocation, especially for primary outcome

Incomplete outcome data (attrition bias)
All outcomes

High risk

Differential attrition ‐ 17% lost to follow‐up in exercise group, none lost to follow‐up in control group

Selective reporting (reporting bias)

High risk

Not all outcomes specified in the trial protocol are reported

Other bias

High risk

CONSORT diagram does not report how many people were assessed to arrive at the 95 participants enrolled

Methods

Study design: RCT

Study grouping: Parallel group

Participants

Baseline characteristics

Exercise

• Number enrolled: 5

• Gender (male/female): 0/5

• Age (years): 51 (40–53)

• Body Mass Index: 26 (23–41)

• Haemodynamics: mPAP (mmHG, RHC): 23 (19‐29)

• Haemodynamics: PVR (Dynes, RHC):

• FVC (% predicted): 98 (92–102)

• NYHA WHO Functional Class (I/II/III/IV): 0/3/2/0

• Medications (single/double/triple): 3/2

• Median sessions 31 of 26

Control

• Number enrolled: 5

• Gender (male/female): 1/4

• Age (years): 53 (42–57)

• Body Mass Index: 28 (26–31)

• Haemodynamics: mPAP (mmHG, RHC): 49 (20‐65)

• Haemodynamics: PVR (Dynes, RHC):

• FVC (% predicted): 78 (72–110)

• NYHA Functional Class (I/II/III/IV): 0/3/2/0

• Medications (single/double/triple): 3/2

Included criteria: participants were included in the study if they had a confirmed diagnosis of idiopathic PAH, familial PAH or PAH associated with connective tissue disorders, based on elevated pulmonary artery pressures (> 25 mmHg at rest or > 30 mmHg during exercise) measured by right heart catheterisation; were medically stable and had been on PAH‐specific pharmaceutical therapy for 3 months prior to enrolment into the study; were in WHO functional class II or III; and were willing to complete the 12‐week supervised and 12‐week home exercise training programmes.

Excluded criteria: participants were excluded if they had:

• resting hypoxaemia requiring supplemental oxygen therapy;

• significant musculoskeletal disease, claudication pain, neurological or cognitive impairment, psychiatric/psychological or mood disorders that may have affected their ability to undertake exercise testing or training;

• a history of moderate or severe chronic lung disease;

• cardiac disease associated with cardiac failure, poorly controlled angina, unstable cardiac rhythm;

• participated in a supervised exercise training programme within the last 12 months

Pretreatment: nil

Interventions

Intervention characteristics

Exercise

• Setting: outpatient

• Components: exercise only

• Training dose (frequency number per week): 3 times per week, 12 weeks

• Training dose (duration ‐ min): 60 min class

• Training dose (intensity): 12 weeks. "Intensity for the lower limb endurance exercises will be prescribed with the aim of achieving 60‐70% HR max (based on age predicted maximum,220‐age [37]), while maintaining SpO2 ≥ 92% and symptom intensity (Borg CR10 dyspnoea < 4 and RPE < 4). Exercise intensity will be progressed, based on the individual’s response to training to maintain HR within the target HR range."

• Training dose (mode): lower limb endurance training (walking and cycling). Lower limb functional strength training (step ups and sit to stands) and endurance training of the upper limbs

• Education (total hours): 0

Control

• Training dose (frequency number per week): nil

• Training dose (duration ‐ min): nil

• Training dose (intensity): nil

• Training dose (mode): nil

• Education (total hours): 0

Outcomes

6MWD

VO₂peak

W_peak

Anaerobic threshold

HRQoL (SF‐36): Physical functioning

HRQoL (Sf‐36): Role physical

HRQoL (SF36): Bodily pain

HRQoL (SF‐36): General health

HRQoL (SF‐36): Vitality

HRQoL (SF‐36): Social function

HRQoL (SF‐36): Role emotional

HRQoL (SF‐36): Mental health

HRQol (CAMPHOR): Symptoms

HRQol (CAMPHOR): Activities

HRQol (CAMPHOR): QoL

Morbidity

Disease progression

Symptoms precluding training

Discontinued training

NYHA class

HRQoL: Physical summary score (SF‐36)

HRQoL: Mental summary score (SF‐36)

Assessed at baseline, 12 weeks (post intervention) and 24 weeks (follow‐up)

Identification

Sponsorship source: Advanced Lung Disease Unit at Royal Perth Hospital and the Lung Institute of Western Australia

Country: Australia

Setting: Outpatient, hospital

Comments:

Author's name: Louise Ganderton

Institution: Curtin University

Email: [email protected]

Address: School of Physiotherapy, Faculty of Health Sciences, The University of Sydney

Notes

Protocol paper published: Ganderton 2011

Thesis available: http://espace.library.curtin.edu.au:80/R?func=dbin‐jump‐full&local_base=gen01‐era02&object_id=198083

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

From thesis: "Permuted block randomisation with block sizes of four was used to generate a randomisation chart. Fourteen blocks were created in total using a web‐based research randomiser."

Allocation concealment (selection bias)

Unclear risk

Not specified

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Not possible to blind participants to intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

From thesis: "The primary investigator (LG) carried out all assessments at baseline, 12 weeks and 24 weeks and was blinded to the participants group allocation...The physiotherapists responsible for conducting the exercise training sessions were not involved in any of the formal assessments"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Data available on all recruited participants for ITT. However planned to enrol 34 and only recruited 10

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

Low risk

Methods

Study design: RCT

Study grouping: Parallel group

Participants

Baseline characteristics

Exercise

• Number enrolled: 10

• Gender (male/female): 2/8

• Age (years): 47 (8)

• Type of PH: Group 1 PH n = 9, CTEPH n = 1

• Haemodynamics: mPAP (mmHG, RHC):

• Haemodynamics: PVR (Wood Units, RHC):

• Height (cm): 168 (12)

• Weight (kg): 69 (11)

• Medications (mono/dual/triple): 2/6/2

• NYHA, WHO Functional Class (I/II/III/IV): 0/3/7/0

Control

• Number enrolled: 10

• Gender (male/female): 4/6

• Age (years): 54 (14)

• Type of PH: Group 1 PH n = 7, CTEPH n = 3

• Haemodynamics: mPAP (mmHG, RHC):

• Haemodynamics: PVR (Wood Units, RHC):

• Height (cm): 165 (5)

• Weight (kg): 76 (17)

• Medications (mono/dual/triple): 3/6/1

• NYHA, WHO Functional Class (I/II/III/IV): 0/1/9/0

Included criteria: adults (≥ 18 years) with confirmed PAH and CTEPH who underwent complete clinical work‐up including RHC. All participants were stable under optimised medical therapy (such as endothelin antagonists, iloprost, sildenafil, calcium channel blockers, anticoagulants, diuretics and supplemental oxygen) for at least 3 months before entering the study. Additional inclusion criteria were WHO functional class II to III

Excluded criteria: no recent syncope, and no skeletal or muscle abnormalities prohibiting participation in an exercise training programme

Pretreatment: nil

Interventions

Intervention characteristics

Exercise

• Setting: inpatient

• Components: "specialized respiratory and exercise training programme"

• Training dose: frequency: cycle ergometry and walking daily, resistance training 5 x/week, 3 weeks

• Training dose: duration: 10‐25 min/day cycle ergo, 60 mins walking/day, 30 mins respiratory training, light weights (500‐1000 g)

• Training dose: intensity: commence at 60%‐80% of HR on CPET, progress as per individual tolerability and improvement

• Intervention (mode): respiratory and exercise training programme as per Mereles 2006 ‐ interval training on cycle ergometer, walking, resistance training, respiratory training (PLB, body perception, yoga, respiratory muscle training)

Control

• "Patients in the control group received a programme without specific exercise training."

Outcomes

Morbidity ‐ adverse events

Disease progression

Precluded from training

6MWD

Identification

Sponsorship source: this work was supported by the German National Research Agency (DFG): “Image‐based V/Q analysis” (FOR 474‐2)

Country: Germany

Setting: inpatient rehabilitation

Comments:

Author's name: Sebastian Ley

Institution: University Hospital Heidelberg

Email: [email protected]

Address: Department of Diagnostic and Interventional Radiology, University Hospital Heidelberg, Im Neuenheimer Feld 430,69120 Heidelberg, Germany

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "patients were randomly assigned to either a training or a control group using a permuted block randomization procedure."

Allocation concealment (selection bias)

Unclear risk

The method of allocation was not specified.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Unabel to blind participants or personnel due to the to intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "Assessment of 6MWD and MR examination were performed by investigators who were blinded to the clinical data and group assignment of the patients. Evaluation of the MR data was done blinded to the clinical setting and in random order."

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All randomised patients were analysed

Selective reporting (reporting bias)

Low risk

Unclear whether trial was registered but reporting does not appear selective

Other bias

Low risk

Methods

Study design: RCT

Study grouping: Parallel group

Participants

Baseline characteristics

Exercise

• Number enrolled: 15

• Gender (male/female): 5/10

• Age (years): 47 (12)

• Type of PH: PAH n = 13, CTEPH n = 2

• Haemodynamics: PASP (mmHG, Echo): 61 (18)

• Haemodynamics: CI (L/min/m2, Echo):

• Haemodynamics: mPAP (mmHG, RHC): 49.5 (17.6)

• Haemodynamics: PVR (Dyne.s/cm5, RHC): 968.7 (444.1)

• Height (cm): 171 (11)

• Weight (kg): 75 (13)

• Medications (single/double/triple): 6/5/4

• NYHA, WHO Functional Class (I/II/III/IV): 0/2/12/1

Control

• Number enrolled: 15

• Gender (male/female): 5/10

• Age (years) 53 (14)

• Type of PH: PAH n = 11, CTEPH n = 4

• Haemodynamics: PASP (mmHG, Echo): 61 (18)

• Haemodynamics: CI (L/min/m2, Echo):

• Haemodynamics: mPAP (mmHG, RHC): 49.6 (12.3)

• Haemodynamics: PVR (Dyne.s/cm5, RHC): 901.8 (358.0)

• Height (cm): 166 (5)

• Weight (kg): 78 (18)

• Medications (single/double/triple): 7/5/3

• NYHA, WHO Functional Class (I/II/III/IV): 0/4/10/1

Included criteria: people with severe chronic PH who were stable and compensated under optimised medical therapy (such as endothelin antagonists, iloprost, sildenafil, calcium channel blockers, anti‐coagulants, diuretics, and supplemental oxygen) for at least 3 months before entering the study were invited to participate. Additional inclusion criteria were age 18‐75 years, WHO functional class II to IV.

Excluded criteria: no recent syncope, and no skeletal or muscle abnormalities prohibiting participation in an exercise programme

Pretreatment: Nil evident

Interventions

Intervention characteristics

Exercise

• Setting: 3 weeks inpatient followed by 12 weeks outpatient, unsupervised training

• Components: exercise training (see below), mental training to improve perception of physical abilities and limits to keep physical exercise safe even in demanding situations, dumbbell training of single muscle groups with low weights (500‐1000 g) and 30 min of respiratory training, including stretching, breathing techniques such as pursed lip breathing, body perception, yoga, and strengthening of respiratory muscles

• Training dose: frequency: inpatient: walking and cycling 7 d/week, resistance ex and respiratory training 5 d/week. Outpatient: cycling 5 x/week, walk twice a week, respiratory training and resistance ex second daily

• Intervention (mode): interval bicycle ergometer training, walking, respiratory training, resistance training

• Training dose: duration: 10‐25 min cycle ergometer, 60 min walking, 30 min resistance training, 30 min respiratory training

• Training dose: intensity: cycle ergometer; 60%‐80% of HR on CPET. HR maintained < 120 bpm, oxygen saturation > 85%

Control

• Intervention (mode): "Patients in the control group received a common rehabilitation program based on healthy nutrition, physical therapy such as massages, inhalation, counselling, and muscular relaxation without exercise and respiratory training but were allowed to perform daily activity as usual. All patients were advised to avoid heavy exercise"

• Training dose: duration: 0 (I) 0 (O)

• Training dose: intensity: 0 (I) 0 (O)

• 10 of 15 participants entered the exercise training arm at the end of the study

Outcomes

6MWD

VO₂peak

W_peak

Morbidity ‐ adverse events

Disease progression

Precluded from training

Anaerobic threshold

HRQoL (SF‐36): Physical functioning

HRQoL (SF‐36): Role physical

HRQoL (SF36): Bodily pain

HRQoL (SF‐36): General health

HRQoL (SF‐36): Vitality

HRQoL (SF‐36): Social function

HRQoL (SF‐36): Role emotional

HRQoL (SF‐36): Mental health

HRQoL:Physical Summary score (SF36)

HRQoL:Mental Summary score (SF36)

HRQol (CAMPHOR): QoL

NYHA Class

Discontinued training

Identification

Sponsorship source: this study was funded by a grant from the German Pulmonary Hypertension Group, Pulmonale Hypertonie e.V., Rheinstetten, Germany.

Country: Germany

Setting: inpatient rehabilitation

Comments:

Author's name: Derliz Mereles

Institution: University Hospital Heidelberg

Email: [email protected]‐heidelberg.de

Address: Department of Cardiology and Pneumology, University Hospital Heidelberg, INF 410, D‐69120 Heidelberg

Notes

Adverse Outcomes
Authors report that all participants tolerated training and had no adverse events during training and no progression of the disease as defined by progression of symptoms, PH or right heart failure. Two participants perceived a short episode of dizziness without fainting immediately after bicycle ergometer training. In 1 participant, oxygen saturation dropped from 88% to 74% during exercise, although the training was performed with an oxygen mask.
Continuous Outcomes
6MWD is reported as a change from baseline at the post‐inpatient and post‐outpatient time points

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Comment: participants were randomly assigned to either a primary training group or a sedentary control group using a permuted block randomization procedure

Allocation concealment (selection bias)

Unclear risk

Comment: there is no comment regarding allocation concealment

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: unable to blind participants and personnel due to nature of intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "The completed questionnaire at baseline was compared with the results after 15 weeks by investigators who were blinded to the patients’ clinical data and group assignment. To avoid bias as far as possible in this study, all measurements and/or offline readings were performed by investigators who were blinded to patient data and group assignment."

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No dropouts reported

Selective reporting (reporting bias)

Low risk

The protocol was not registered or published however the outcome reporting is comprehensive.

Other bias

High risk

Comment: No CONSORT diagram so not possible to tell how many people were assessed in order to recruit the sample.

Methods

Study design: RCT

Study grouping: Parallel group

Participants

Baseline characteristics

Exercise

• Number enrolled: 18

• Age: unclear

• Type PH: unclear

Control

• Number enrolled: 18

• Age: unclear

• Type of PH: unclear

Included criteria: "Clinically stable PH patients in a single centre"

Excluded criteria: unclear

Interventions

Intervention characteristics

Exercise

• Setting: outpatient, 3 months, 1 supervised session followed by unsupervised home training, telephone follow‐up

• "Best practice treatment plus a physiotherapist‐led rehabilitation programme (rehabilitation group). Patients in the rehabilitation group attended a single one to one class with a physiotherapist and received a prescribed set of exercises tailored to their needs. They also received telephone support during the 3 month period and were encouraged to continue with their regular exercise regime."

Control

• "Best practice treatment"

Outcomes

Incremental shuttle walk test

Endurance shuttle walk test

Assessed at baseline and 3 months

Identification

Sponsorship source:

Country:

Setting:

Comments:

Author's name: Anna Wilkinson

Institution: Royal Hallamshire Hospital

Email:

Address:

Notes

Reported as two abstracts

In the Thorax abstract it does not specify the number in each group, only that 40 were randomised. ERS abstract says 18 in each group. Neither specifies age by allocated group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Abstract only, does not specify how sequence was generated

Allocation concealment (selection bias)

Unclear risk

Abstract only, does not specify

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Not possible to blind participants to intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "Blind assessment was undertaken pre intervention and following 3 months"

Incomplete outcome data (attrition bias)
All outcomes

High risk

Dropouts unclear. 2007 abstract specifies 40 participants and 2008 abstract specifies 36 participants.

Selective reporting (reporting bias)

High risk

Abstract only, not all outcomes reported

Other bias

High risk

Abstract only