Engstrom 1999.
Study characteristics | ||
Methods | RCT; follow‐up: 12 months; control group: usual outpatient care | |
Participants | Eligible: 58 Randomised: 55 Completed: 50, I: 26, C: 24 Mean age: I: 66 years, C: 67 years Sex (% male): I: 54, C: 50 Inclusion criteria: clinical diagnosis of COPD, developing after ≥ 10 years of smoking, FEV₁ < 50%, debut of symptoms after 40 years of age, dyspnoea mainly elicited by exercise or infection, no allergy Major exclusions: disabling or severe disease, coexistence of other causes of impaired pulmonary function |
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Interventions | 12‐month rehabilitation programme including ‐ Exercise training sessions (bicycle, arm, and breathing techniques), 2/week for 6 weeks, once weekly for 6 weeks, once every second week for 6 weeks, and then once a month for remaining period. Every session: 45 minutes. Furthermore, instructions for daily walks and an individualised daily 30‐minute home training programme ‐ Individualised educational programme with outpatient team (nurse and physician) on visit every 3 months ‐ Occupational therapist gave 2 group sessions about energy‐saving techniques and 2 global educational sessions ‐ Dietician gave information about nutrition for COPD patients and intervened in malnutrition Intervention duration: 12 months Involved disciplines: physiotherapist, nurse, physician, dietician, occupational therapist |
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Outcomes | SGRQ, 6MWD, W‐max, days in hospital, SIP, MACL | |
Notes | Dominant c omponent: exercise | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: no information reported |
Allocation concealment (selection bias) | High risk | Quote: "patients with COPD were recruited consecutively and, when a sufficient number had been collected, randomised to produce a rehab group and a control group of equal size" |
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 | Low risk | Quote: "all the physiological and QOL assessments were blinded, except the walking test, which was performed by the nurse in the rehabilitation team" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: missing outcome data balanced in numbers across intervention and control groups (2 vs 3 persons) |
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 |