Methods | Parallel group RCT | |
Participants |
N Randomised: 20 (exercise 10; control 10) Diagnosis (% of participants): Aetiology: IHD; DCM NYHA: Class II 90%; Class III 10% LVEF: exercise mean 26.1% (SD 6); control mean 24.7% (SD 8) Case mix: 100% as above Age (yr): exercise 55 (SD 6); control 53 (SD 9) Male: 100% White: not reported Inclusion/exclusion criteria Inclusion: age < 70 yr with CHF (NYHA II to III) as result of DCM or IHD as assessed by cardiac catheterisation. All had clinical, radiological and echocardiographic signs of CHF and an LVEF 40% as assessed by ventriculography and clinically stable condition for > 3 months before enrolment Exclusion: significant valvular heart disease, uncontrolled hypertension, peripheral vascular disease, pulmonary disease or musculoskeletal abnormalities precluding exercise training |
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Interventions |
Exercise:Total duration: 2 wk inpatient followed by 6 months as outpatient Aerobic/resistance/mix: aerobic Frequency: 7 sessions/wk Duration: 20 min/session Intensity: 70% symptom limited VO2 max Modality: cycle ergometers Setting: supervised sessions at hospital and home‐based unsupervised sessions Other: expected to participate in 1 group training session (walking, callisthenics and non‐competitive ball games) of 60 min each wk. Participants were asked to exercise for 20 min/day at home |
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Outcomes | Mortality | |
Comparison | Continued their sedentary lifestyle and remained on their individually tailored cardiac medication supervised by their private physicians | |
Country and setting | Switzerland Single centre |
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Follow‐up | 26 wk (after randomisation) | |
Notes | ||
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 | All outcomes described in methods are reported in results |
Intention‐to‐treat analysis? | Low risk | Although ITT analysis not reported, groups do appear to be analysed according to original randomised allocation |
Incomplete outcome data? | Low risk | No loss to follow‐up |
Groups balanced at baseline? | Low risk | "Patients in the training group and in the control group showed a significantly reduced left ventricular ejection fraction (training group: 26.1 ±3.1%, control group: 24.7± 2.4%; NS [not significant]) and exercise capacity as determined by peak oxygen uptake (training group: 20.3 ±1.0 ml/kg min, control group: 17.9 ±1.6 ml/kg min; P NS)" |
Groups received same intervention? | Unclear risk | Details of co‐interventions not reported |