Li 2018.
| Study characteristics | ||
| Methods | RCT, parallel group. Setting: China. Study duration: 12 months | |
| Participants | 151 participants Intervention: n = 82, Control: n = 69 Male: n = 126, Female: n = 25 Age, mean and SD: Intervention: 65.1 ± 8.7, Control: 66 ± 9.3 FEV1% predicted, mean and SD: Intervention: 48.7 ± 11.7, Control: 49.2 ± 11.0 Inclusion criteria: Diagnosis of COPD according to GOLD guideline, clinically stable in the first 4 weeks, able to complete the PR programme and questionnaire survey successfully and independently, willing to participate in the PR and maintenance program, and willing to sign informed consent. Exclusion criteria: Participants having asthma, obstructive sleep apnea syndrome, or underdiagnosis of cancer; diagnosed with Alzheimer’s disease or depression and anxious disorder; unavailable for exercise even during the stable stage; having severe dysfunction of the heart, liver, or kidney; and suffering emotional trauma in the previous 6 months such as relative death and divorce. The exit criteria included exacerbation during PR and maintenance, frequent accident events during PR and maintenance, and death. |
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| Interventions | Intervention group: Components: exercise and education home‐based Supervision: Step 1: Home‐visit once every 2 weeks to conduct rehabilitation exercise strategy and provide health education for 2 months. Step 2: Home‐visit every 4 weeks and phone contact once a week for 4 months. Step 3: Phone contact once a week for 6 months. Phone contact once a week for 6 months. Control group: usual care. |
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| Outcomes | Exercise capacity: 6MWD, HRQoL: CAT, mortality and exacerbation rate. | |
| Notes | Grants from the National Natural Science Foundation of China (No. 81270144, 81570084, 30800507), and the Science and Technology Plan Project of Tianjin (13ZCZDSY02000). | |
| 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 | Insufficient information. Method of concealment not described. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Percentage attrition was 17% for intervention group and 37% in control group. There were more participants lost to follow up in the control group compared to the intervention group |
| Selective reporting (reporting bias) | Unclear risk | No protocol or trial registry information found, unclear if outcomes were reported as planned. |
| Other bias | Unclear risk | Any self‐reported outcomes are likely to be affected any bias. |