Hambrecht 2000.
| 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, years: 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 |
|
| Interventions |
Exercise: Total duration: 6 months Aerobic/resistance/mix: aerobic Frequency: 6 or 7 sessions/week Duration: 10 to 20 minutes/session Intensity: 70% of peak VO₂ Modality: cycle ergometer Setting: first 2 weeks in hospital, remainder home based Other: plus group sessions 1 hour twice weekly, walking, ball games, and calisthenics Control group / Comparison: Continued individually tailored cardiac medications, supervised by physicians |
|
| Outcomes | Mortality | |
| Country and setting | Germany Single centre |
|
| Follow‐up | 6 months (after randomisation) | |
| Notes | Source of funding: Grant Ha 2155/3‐2, from the Deutsche Forschungsgemeinschaft (DFG), Bonn, Germany | |
| 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 using 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 the methods were reported in the results |
| Intention‐to‐treat analysis? | Low risk | Not reported |
| Incomplete outcome data? | Low risk | QUORUM diagram and details of losses to follow‐up were 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 | Co‐interventions in the control group were not reported |