Methods | Parallel group RCT | |
Participants |
N Randomised: 85 (training 44; control 41) Diagnosis (% of participants): * Aetiology: ischaemic 59%; DCM 41% NYHA: Class I 16%; Class II 69%; Class III 34% LVEF: training: 35% (SD 9.3); control 32.3 (SD 14.1) Case mix: 100% as above Age (yr): exercise 60 (SD 13); control 61 (SD 13) Male: 87% White: not reported Inclusion/exclusion criteria Inclusion: impaired left ventricular systolic function (EF < 45%) and exercise capacity (peak VO2 < 25 mL/min/kg) Exclusion: NYHA Class IV, MI or unstable angina < 6 months before the examination, exercise‐limiting diseases, and severe pulmonary or renal disease * baseline data only available for 85 participants |
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Interventions |
Exercise:Total duration: 9 months Aerobic/resistance/mix: aerobic Frequency: > 3 sessions/wk Duration: 30 min/session Intensity: 65% max VO2 Modality: cycle Setting: home‐based Other: not reported |
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Outcomes | HRQoL (MLWHFQ) Morbidity |
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Comparison | Not reported | |
Country and setting | Italy Not reported |
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Follow‐up | 9 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 | Exercise test assessor blinded |
Selective reporting (reporting bias) | Unclear risk | Not reported |
Intention‐to‐treat analysis? | Low risk | Although ITT not stated, groups appeared to be analysed according to original randomisation |
Incomplete outcome data? | Low risk | Outcomes described in methods reported in results |
Groups balanced at baseline? | Low risk | "The two groups did not differ as to age, gender, NYHA functional class, EF, pharmacologic treatment, or HF etiology (Table 1)" |
Groups received same intervention? | Low risk | "Patients in [control] group underwent follow‐up visits at the third and ninth month to exclude changes in their usual lifestyle and physical activity" |