Linneberg 2012.
| Study characteristics | ||
| Methods | RCT, parallel group. Setting: Denmark. Study duration: 12 months | |
| Participants | 118 participants Intervention: n = 59, Control: n = 59 Male: n = 45, Female: n = 73 Age, years (%) Intervention: 60 (11.9%), 60 – 69 (30.5%), 70 – 79 (40.7%) and > 80 (16.9%); Control: < 60 (10.2%), 60 – 69 (27.1%), 70 – 79 (54.2%) > 80 (8.5%) FEV1% predicted, mean: Intervention: 42.5, Control: 41.9 Inclusion criteria: Participants should be able to walk, no significant cognitive impairment, no symptomatic ischaemic heart disease, should be able to understand Danish. No exacerbation of COPD within 4 weeks prior to start of rehabilitation. Exclusion criteria: Participants in need of supplementary oxygen. |
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| Interventions | Intervention group: Components: aerobic and strength training These supplemental exercise sessions were similar to the ones that were part of the initial 7‐week rehabilitation programme. The participants were encouraged to train and walk every day at home and the walking time was recorded in a diary. The sessions started with a warm‐up exercise followed by individually planned walking and cycle training. In addition, the participants were taught about four exercise activities aimed to strengthen legs, arms, abdominal and thoracic muscles. The participants were encouraged to train and walk every day at home and the walking time was recorded in a diary. Supervision: Manteinance group received six supervised exercise sessions at week 9, 11, 13, 18, 26 and 52. These supplemental exercise sessions were similar to the ones that were part of the initial 7‐week rehabilitation programme. The intervention group was asked to complete a diary with home‐based training time, and this was checked by the study nurses. Control group: Usual care without receive any additional exercise sessions, were not further encouraged to do home‐based exercise and not asked to complete a diary. |
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| Outcomes | Exercise capacity: ESWT and HRQoL: SGRQ (global score) | |
| Notes | No study sponsor. This trial is registered at ClinicalTrials.gov (Protocol ID: KA20060179) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Patients were randomised (in blocks of 20) for the intervention group or the control group. No further information. |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information. Method of concealment not described. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label study. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar attrition in both groups (17% in the intervention arm and 15% in the control arm). |
| Selective reporting (reporting bias) | Unclear risk | There is a register of CT. Reported the primary outcomes, all outcomes reported as planned except for hospital data not reported. |
| Other bias | Unclear risk | Any self‐reported outcomes are likely to be affected any bias. |