Methods | Parallel group RCT | |
Participants |
N Randomised: 22 (exercise 12; control 10) Diagnosis (% of participants): Aetiology: DCM 86%, ischaemic heart disease 14% NYHA: Class II (55%); Class III (45%) LVEF: exercise 26% (SD 9); control 27% (SD 10) Case mix: 100% as above Age (yr): exercise 50 (SD 12); control 52 (SD 8) Male: 100% White: not reported Inclusion/exclusion criteria Inclusion: EF < 40% as assessed by radionucleotide scintigraphy, and a reduced fractional shortening < 30% assessed by echocardiography; willingness to participate in the study for the next 6 months; and a permanent residence within 25 km of the training facility. Physical work capacity at baseline > 25 watts without signs of myocardial ischaemia (i.e. angina or ST segment depression). Clinically stable > 3 months Exclusion: exercise‐induced myocardial ischaemia or ventricular tachyarrhythmias (higher then Lown Class IVa), valvular heart disease, uncontrolled hypertension, peripheral vascular disease, COPD, and orthopaedic or other conditions precluding regular participation in exercise sessions |
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Interventions |
Exercise:Total duration: 6 months Aerobic/resistance/mix: aerobic Frequency: 4‐6 sessions/wk Duration: 10‐60 min/session, 1 hr at home Intensity: 70% VO2max Modality: cycling, walking, ball games and callisthenics Setting: first 3 wk supervised hospital‐based training; thereafter home‐based Other: none |
|
Outcomes | Morbidity and mortality | |
Comparison | After discharge medical therapy continued and participants supervised by private physician | |
Country and setting | Germany Single centre |
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Follow‐up | 6 months (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, reported in results |
Intention‐to‐treat analysis? | Unclear risk | Not reported |
Incomplete outcome data? | Low risk | Drop‐outs and clinical events are fully reported for both groups. No imputation undertaken |
Groups balanced at baseline? | Low risk | "There were no significant differences in baseline variables between the training and control groups" |
Groups received same intervention? | Unclear risk | The exercise group had 3 wk of hospital stay, the control only 3 days. The control group follow‐up with private physician. No comment on follow‐up of intervention group |