Mendes 2010.
Study characteristics | ||
Methods | RCT; follow‐up 12 weeks; 2 intervention groups (at‐home PR vs outpatient PR); 1 control group: usual care | |
Participants | Eligible: 117 Randomised: 117 (intervention I: 42, intervention II: 46, control: 29) Analysed: 85 (intervention group I: 33, intervention II: 23, control: 29) Mean age: intervention I: 66 years, intervention II: 71, control: 71 Sex (% male): intervention I: 82, intervention II: 83, control: 66 Inclusion criteria: diagnosis of COPD according to GOLD, stable at inclusion Major exclusions: hospitalisation or COPD instability; presence of neuromuscular disease, associated respiratory disease, orthopaedic or neurological disease that affected gait; recent impairment due to comorbidities such as myocardial infarction, heart failure, stroke, or neoplasm; prior pneumonectomy or other thoracic surgery |
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Interventions | Home ‐ based or outpatient self‐monitored pulmonary rehabilitation program me ‐ Both intervention groups received 1 session of education about COPD, treatment and relevance of PR ‐ Both intervention groups trained 3 mornings a week for 3 months, with aerobic and strengthening exercises. Patients in the outpatient clinic trained under supervision; patients who trained at home were instructed in the clinic and received support through telephone calls Intervention duration: 3 months Disciplines involved: physiotherapist, pulmonologist |
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Outcomes | 6MWD, MRC, FEV₁, BMI, all included in BODE index (body mass, obstruction, dyspnoea, exercise tolerance) | |
Notes | Dominant component: exercise | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were randomised electronically by a computer" |
Allocation concealment (selection bias) | High risk | Comment: distribution of patients was unequal: 42 in at‐home group, 46 in outpatient group vs 29 in control group |
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 | Quote: "two duly trained health care professionals were responsible for the evaluations, which were performed by the same evaluators for all patients" Comment: not clear whether these professionals were blinded to group allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "19 out of 46 of outpatient intervention group were lost to follow up, compared to 7 out of 42" Comment: reasons for missing outcome data likely to be related to true outcome, with imbalance in quantities of missing 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 |