van Wetering 2010.
| Study characteristics | ||
| Methods | RCT; follow‐up: 24 months, control group: usual care | |
| Participants | Eligible: 199 Randomised: 199, I: 102, C: 97 Completed: I: 77, C: 81 Mean age: I: 66 years, C: 67 years Sex:: I: 71%, C: 71% Inclusion criteria: diagnosis of COPD according to guidelines, other inclusion criteria: impaired exercise capacity, W‐max < 70%, GOLD 2 + 3, clinically stable at inclusion Major exclusion criteria: prior rehabilitation, patients with serious comorbidity that precluded exercise therapy |
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| Interventions | Community‐based COPD management programme ‐ Intensive 4‐month standardised, supervised physiotherapy 2/week (30 minutes), with home‐based exercise ‐ Participation in an individualised education programme ‐ All smokers were offered smoking cessation counselling ‐ Nutritionally depleted patients received counselling from a dietician ‐ During 20‐month active maintenance phase, patients were instructed to train at home and visited the physiotherapist once a month. Dietician support was continued Intervention duration: 16 weeks followed by 20 months ' maintenance Involved disciplines: nurse, physiotherapist, dietician |
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| Outcomes | SGRQ, total score, number of exacerbations, mMRC, exercise performance (measured as maximum Watts: W‐max), 6MWD, muscle strength, isometric quadriceps peak torque, maximum inspiratory mouth pressure, fat‐free mass, lung function | |
| Notes | Dominant component of programme: exercise | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "patients were randomised to INTERCOM or usual care using a computerised procedure with concealed patient allocation" |
| Allocation concealment (selection bias) | Low risk | Quote: "patients were randomised to INTERCOM or usual care using a computerised procedure with concealed patient allocation" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: p articipants and treating therapists not likely to have been blinded to group allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "all outcome measurements were assessed single blind" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: results were analysed by intention‐to‐treat |
| Selective reporting (reporting bias) | Low risk | Comment: study protocol is not available, but it is clear that published reports include all expected outcomes, including those that were pre‐specified |