Theander 2009.
Study characteristics | ||
Methods | RCT; 3 months; control group: usual care | |
Participants | Eligible: 30 Randomised: 30, I: 15, C: 15 Completed: 26, I: 12, C: 14 Mean age: I: 66 years, C: 64 years Sex (% male): I: 25, C: 71 Inclusion criteria: diagnosis of COPD according to British guidelines, with FEV₁ between 60% and 25% post bronchodilation, age ≤ 75 years Major exclusions: disabling or severe disease other than COPD, impaired pulmonary function due to other disease, long‐term oxygen therapy, alpha₁‐antitrypsin deficiency, cancer disease, untreated obstructive sleep apnoea syndrome, no COPD‐related symptoms affecting activities of daily life |
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Interventions | Multi‐disciplinary programme ‐ Physiotherapy 2 days per week (1 hour) for 12 weeks, with additional home training after 1 month ‐ Dietician support (3 sessions of 1 hour): education and, if needed, additional nutritional supplementation ‐ Occupational therapist: education and teaching ‐ Nurse (2 sessions of 1 hour): education and self‐care advice Intervention duration: 3 months Disciplines involved: physiotherapist, dietician, occupational therapist, nurse |
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Outcomes | BMI, FEV₁, fatigue impact scale, 6MWD, grip strength, SGRQ, SF‐36 | |
Notes | Dominant component: exercise | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "for the randomisation we prepared 80 sealed opaque envelopes with assignment information: 40 for the rehabilitation group and 40 for the control group" |
Allocation concealment (selection bias) | Low risk | Quote: "randomization procedures were performed by an independent person from the research group, who took a random envelope from the prepared box with sealed envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: p articipants and treating therapists not likely to have been blinded to group allocation |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "the data collection was performed by members of the rehabilitation group. The data collection was not blinded to the data collector" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: c omparable dropout rates |
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 |