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. 2021 Sep 8;2021(9):CD009437. doi: 10.1002/14651858.CD009437.pub3

Cambach 1997.

Study characteristics
Methods RCT with cross‐over design; follow‐up: 6 months; control group: drug treatment only
Participants Eligible (asthma and COPD) : 89
Analysed (COPD) : 23 (COPD) , I: 15, C: 8
Mean age: I: 62 years, C: 62 years
Sex (% male): I: 47, C: 75
Inclusion criteria: diagnosis of asthma or COPD according to guidelines, evidence of dyspnoea and decreased exercise tolerance as a result of obstructive lung disease, 18 to 75 years of age, ability to travel independently to the physiotherapy practice, medication prescribed by a pulmonary physician, motivation to improve self‐care, informed consent
Major exclusions: manifested cardiac complaints, hypercapnia and/or hypoxia
Interventions 3‐month rehabilitation programme including drug treatment
Exercise group sessions of 3 to 4 participants including techniques of breathing retraining and evacuation of mucus, exercise training, patient education, relaxation techniques, and recreational activities. Training was provided 3 days a week for 90 minutes. Exercise training was performed twice a week on a cycle ergometer and by stair‐walking. Recreational activities were provided once a week for 45 minutes. Educational sessions were provided every week for 45 minutes
Intervention duration: 12 weeks
Involved disciplines: nurse, physiotherapist
Outcomes 6MWD, incremental cycle ergometer test, CRQ
Notes Dominant component: exercise
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "block randomisation procedure; four closed envelopes for condition RC and four closed envelopes for condition CR"
Allocation concealment (selection bias) Low risk Quote: "four closed envelopes"
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: participants and treating therapists not likely to have been blinded to group allocation
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: outcome assessors not likely to have been blinded to intervention, as patients were tested for exercise capacity in their practices, by their treated physiotherapist, who was probably not blinded to group allocation
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: “data obtained from patients who did not return for one or more of the assessments (i.e. baseline (t0), after 3 months (t3) and/or after 6 months (t6), or patients who were not measured within 3 weeks (from t0, t3 and t6) were excluded from data analysis"
Comment: exclusion of non‐responders may have affected outcome data
Selective reporting (reporting bias) Low risk Comment: study protocol is not available, but it is clear that published reports include all expected outcomes, including those that were pre‐specified