Methods | Parallel group RCT | |
Participants |
N Randomised: 73 (exercise 36; control 37) Diagnosis (% of participants): Aetiology: IHD 16%; DCM 84% NYHA: Class I and II 74%; Class III 26% LVEF: 29% (SD 9) Case mix: 100% as above Age (yr): exercise 54 (SD 9); control 54 (SD 8) Male: 100% White: not reported Inclusion/exclusion criteria Inclusion: documented HF by signs, symptoms and angiographic evidence of reduced left ventricular function (LVEF < 40%) as a result of DCM or IHD; physical work capacity at baseline > 25 watts, clinical stability >=3 months before study start Exclusion: significant valvular heart disease, uncontrolled hypertension, DM, hypercholesterolaemia, PVD, pulmonary disease, musculoskeletal abnormalities precluding exercise training |
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Interventions |
Exercise:Total duration: 6‐months Aerobic/resistance/mix: aerobic Frequency: 6 or 7 sessions/wk Duration: 10‐20/session Intensity: 70% of peak VO2 Modality: cycle ergometer Setting: first 2 wk in hospital, remainder home based Other: plus group sessions 1 hr twice weekly, walking, ball games and callisthenics |
|
Outcomes | Mortality | |
Comparison | Continued individually tailored cardiac medications, supervised by their physicians | |
Country and setting | Germany Single centre |
|
Follow‐up | 6 months (after randomisation) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were randomly assigned to either a training group or an inactive group sing a list of random numbers" |
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 reported in results |
Intention‐to‐treat analysis? | Low risk | Not reported |
Incomplete outcome data? | Low risk | QUORUM diagram and details of losses to follow‐up reported |
Groups balanced at baseline? | Low risk | "No significant differences were observed between the two groups with regard to demographic or clinical data, including age, weight, LVEF, LVEDD [Left Ventricular End Diastolic Diameter], NYHA or maximum oxygen uptake" |
Groups received same intervention? | Unclear risk | The co‐interventions in the control group not reported |