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. 2021 Sep 8;2021(9):CD009437. doi: 10.1002/14651858.CD009437.pub3

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
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
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