Mueller 2007.
Methods | Parallel‐group RCT | |
Participants |
N randomised: 50 (exercise 25, control 25) Diagnosis (% of participants): Aetiology: ischaemic, DCM (% not reported) NYHA: not reported LVEF: < 40% (% not reported) Case mix: 100%, as above Age, years: 55 (SD 10) Male: 100% White: not reported Inclusion/exclusion criteria: Inclusion: CHF documented by clinical, angiographic, or echocardiographic criteria; resting EF < 40% Exclusion: not reported |
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Interventions |
Exercise: Total duration: 1 month Aerobic/resistance/mix: aerobic Frequency: 5 sessions/week Duration: 30 minutes/session cycling, 90 minutes walking each day Intensity: Borg 12 to 14 (60% to 80% max HR) Modality: cycling and walking Setting: indoor cycling sessions were supervised directly by a medical resident; outdoor walking sessions were supervised by exercise physiologists Other: resided at the rehabilitation centre for 1 month; programme also included education and low‐fat meals prepared daily by the centre's cook Control group / Comparison: Usual medical care |
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Outcomes | Morbidity, mortality | |
Country and setting | Switzerland Single centre |
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Follow‐up | 6.2 years (after randomisation) | |
Notes | Source of funding: RAHN‐Medizinfonds, Zurich; Schweizerische Herzstiftung, Switzerland | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
Selective reporting (reporting bias) | Low risk | Outcomes described in the methods were reported in the results |
Intention‐to‐treat analysis? | Low risk | ITT was not stated explicitly; however, groups appear to have been analysed according to the original allocation |
Incomplete outcome data? | Low risk | "Data from one patient in the control group was not available at the two‐month evaluation due to refusal to complete testing." "Among subjects in the exercise group, 9 died, and one refused repeat testing. Among patients in the control group, 12 died and two refused repeat testing. Therefore, 14 and 13 patients performed six‐year evaluations in the exercise and control groups, respectively" QUORUM diagram reported and detailed text provided; no imputation undertaken |
Groups balanced at baseline? | Low risk | "No differences were observed between the exercise and control groups initially in clinical or demographic data, including age, height, weight, pulmonary function or medication status" |
Groups received same intervention? | Unclear risk | "Patients in the exercise group resided at the rehabilitation centre for one month. Control subjects received usual clinical care, including verbal encouragement to remain physically active" |