Methods | Parallel group RCT | |
Participants |
N Randomised: 25 (exercise 12; control 13) Diagnosis (% of participants): Aetiology: ischaemic 100% NYHA: not reported LVEF: exercise 31.5% (SD 7); control 33.3% (SD 6) Case mix: 100% as above Age (yr): exercise 56 (SD 5); control 55 (SD 7) Male: 100% White: not reported Inclusion/exclusion criteria Inclusion: MI, diagnosis of HF and stable symptoms, LVEF < 40% Exclusion: pulmonary disease |
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Interventions |
Exercise:Total duration: 2 months Aerobic/resistance/mix: aerobic Frequency: walking: 2 sessions/daily; cycling: 4 sessions/wk Duration: walking: 1 hr; cycling: 45 min Intensity: walking: not reported; cycling: 60‐70% peak VO2 Modality: walking and cycling Setting: centre based with supervised by physicians Other: exercise groups received education sessions and low‐fat meals prepared 3 times daily |
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Outcomes | Hospitalisation and mortality | |
Comparison | Usual clinical follow‐up | |
Country and setting | Switzerland Single‐centre |
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Follow‐up | 2 and 12 months (after randomisation) | |
Notes | "After the initial 2‐months exercise training or control period, both groups were encouraged to remain physically active over the subsequent 10 months, although no formal program was implemented" | |
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? | Low risk | Although not explicit, participants appeared to be analysed according to initial random allocation |
Incomplete outcome data? | Low risk | Lost to follow‐up reported |
Groups balanced at baseline? | Low risk | "No differences were observed between the 2 groups initially in clinical or demographic data, including age, height, weight, resting blood pressure, pulmonary function, ejection fraction, or maximal oxygen uptake" |
Groups received same intervention? | Low risk | Yes, both groups appeared to receive same interventions apart from CR intervention |