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. 2021 Aug 17;2021(8):CD013569. doi: 10.1002/14651858.CD013569.pub2

Du Moulin 2009.

Study characteristics
Methods RCT, parallel group. Setting: Germany. Study duration: 6 months
Participants 20 participants
Intervention: n = 10, Control: n = 10
Males: n = 14, Female: n = 6
Age, mean (95% CI): Intervention: 67 (63 ‐ 72), Control: 72 (69 ‐ 77)
FEV1% predicted, mean (95% CI): Intervention: 58.6 (53.8 ‐ 63.5), Control: 62.5 (57.7 ‐ 67.3)
Inclusion criteria: Participants diagnosed with moderate COPD and that completed a comprehensive, multidisciplinary, 3‐week outpatient pulmonary rehabilitation programme. Only participants not planning to attend some other form of structured maintenance programme were included.
Exclusion criteria: Participants who were not capable of carrying out the exercise training because of cardiac, pulmonary or orthopedic problems.
Interventions Intervention group:
Components: This group received an individualized training plan, based on their last 6MWT.
Participants were instructed to quickly walk a distance equivalent to 125% of their last 6MWT three times a day with each training walk not exceeding 15 min. Alternatively, these three training walks could be combined to one training walk a day. The training was carried out independently in a home‐based setting. Participants were given a pedometer so that the training could be better incorporated into daily activities. Patients kept a training diary. The diary was returned by post and was renewed every 4 weeks.
Supervision: Participants were contacted by telephone every 4 weeks.
Control group: Usual care. No instructions were given regarding physical activities during the period following rehabilitation.
Outcomes Exercise capacity: 6MWD and HRQoL: CRQ domains
Notes No study sponsor.
Trial is registered at the Hamburg Chamber of Physicians (No. 2617)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Reported as randomised, but no further information.
Allocation concealment (selection bias) Unclear risk For randomization purposes, were prepared 20 envelopes, 10 with a plus, indicating intervention group, and 10 with a minus, indicating control group. Patients drew these envelopes themselves.
Blinding of participants and personnel (performance bias)
All outcomes High risk This trial only observer was blind
Blinding of outcome assessment (detection bias)
All outcomes Low risk Observer was blinded.
Incomplete outcome data (attrition bias)
All outcomes High risk Percentage attrition was high in both groups: intervention group: 50% and control group 60%.
Selective reporting (reporting bias) Unclear risk Could not find in trial registry, and could not find a protocol so unclear if outcomes were reported as planned.
Other bias Unclear risk Any self‐reported outcomes are likely to be affected any bias