Bendstrup 1997.
Study characteristics | ||
Methods | RCT; follow‐up: 24 weeks; control group: no treatment | |
Participants | Randomised: 47, I: 22, C: 20 Completed: 32, I: 16, C: 16 Mean age: I: 64 years, C: 65 years Sex (% male) both groups: 56 Inclusion criteria: diagnosis of COPD according to GOLD, FEV₁ 25% to 55% of predicted value, Tiffeneau index < 70%, stable condition for 4 weeks (no change in exercise status, sputum colour/quantity, no change in medication) Major exclusions: heart disease, musculoskeletal disease limiting exercise, intermittent claudication limiting exercise |
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Interventions | Comprehensive outpatient rehabilitation programme ‐ Exercise training (strength training, backwards/sideways walking, endurance training): 3 times per week for 1 hour during 12 weeks. Patients were encouraged to train at home ‐ Occupational therapy: 2 group sessions ‐ Education: 12 sessions, including proper administration, inhalation techniques, psychological education, socioeconomic problems, and nutrition ‐ Smoking cessation: free nicotine patches, education Intervention duration: 12 weeks Involved disciplines: practice nurse, physiotherapist, dietician, psychologist, occupational therapist, social worker, physician |
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Outcomes | CRDQ, YQLQ, 6MWD, lung function, patient attendance, staff working hours | |
Notes | Dominant component: exercise | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "the patients were randomly allocated to either an intervention or a control group" Comment: no information on allocation procedure provided |
Allocation concealment (selection bias) | Unclear risk | Comment: methods used to conceal the sequence of treatment group allocation were not available |
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 | Unclear risk | Comment: we could not ascertain how and whether outcome assessors were blinded to treatment group assignment |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: high dropout rate (31%) |
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 |