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. |
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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. |
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Outcomes | Exercise capacity: 6MWD and HRQoL: CRQ domains | |
Notes | No study sponsor. Trial is registered at the Hamburg Chamber of Physicians (No. 2617) |
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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 |