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 |
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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 |
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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 |