Güell 2006.
Study characteristics | ||
Methods | RCT; follow‐up: 4 months; control group: usual care | |
Participants | Randomised: 40, I: 20, C: 29 Completed: 35, I: 18, C: 17 Mean age: I: 68 years, C: 66 years Male: I: 88%, C: 100% Inclusion criteria: age ≤ 75 years, FEV₁ < 70%, FEV₁/FVC < 65%, PaO₂ > 55 mmHg at rest with no indication for prescribing home oxygen therapy Exclusion criteria: psychiatric disturbance; no heart, bone, or joint disease; exacerbation or hospitalisation in previous 2 months |
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Interventions | Pulminary rehabilitation programme of 4 months, including ‐ First 2 months: two 30‐minute sessions each week, including relaxation techniques, breathing retraining, and chest wall and abdominal muscle wall work. Patients attended four 45‐ to 60‐minute educational sessions ‐ Month 2 to 4: five 30‐minute sessions weekly exercise training on cycle ergometer Intervention duration: 4 months Disciplines involved: nurse, physiotherapist, pulmonologist |
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Outcomes | MBHI, Revised Symptom Checklist (SCL‐90‐R), 6MWD, CRQ | |
Notes | Dominant component: exercise | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomization was done at inclusion of consecutive patients" Comment: it is not clear how the sequence was generated |
Allocation concealment (selection bias) | High risk | Quote: "randomization was not concealed" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "neither patients nor clinicians were blinded to allocation" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the technicians who collected the data were blinded to patient allocation, as were the data analysts, until the analysis was deemed complete" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: l oss to follow‐up comparable between groups (2 vs 3) |
Selective reporting (reporting bias) | Low risk | Comment: a ll outcomes reported |