Methods | Parallel group RCT | |
Participants |
N Randomised: 99 (exercise 50; control 49) Diagnosis (% of participants): Aetiology: ischaemic cardiomyopathy 85%; idiopathic DCM 15% NYHA: Class II 49%; Class III 34%; Class IV 17% LVEF: exercise 28.4 (SD 6); control 27.9 (SD 5) Case mix: see above Age (yr): exercise 56 (SD 7); control 53 (SD 9) Male: 89% White: not reported Inclusion/exclusion criteria Inclusion: HF, LVEF < 40%, and sinus rhythm, diagnosis of CHF based on clinical symptoms and signs with or without radiological evidence of pulmonary congestion Exclusion: unstable angina, recent acute MI, decompensated congestive HF, haemodynamically significant valvular heart disease, significant chronic pulmonary illness, uncontrolled hypertension, renal insufficiency (serum creatinine > 2.5 mg/dL), and orthopaedic or neurological limitations) |
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Interventions |
Exercise:Total duration: 14 month; 8 wk supervised then 12 months maintenance Aerobic/resistance/mix: aerobic Frequency: 2‐3 sessions/wk Duration: 40 min/session Intensity: 60% max VO2 Modality: cycling Setting: hospital‐based programme Other: all sessions were supervised by a cardiologist |
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Outcomes | HRQoL (MLWHFQ); mortality; morbidity; cost‐effectiveness | |
Comparison | Standard medical care | |
Country and setting | Italy Single centre |
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Follow‐up | 14 and 26 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 | Losses to follow‐up reported |
Groups balanced at baseline? | Low risk | "The baseline characteristics of the study population are shown in Table 1. The 2 groups were well balanced with respect to most characteristics, including peak VO2, New York Heart Association functional class, and left ventricular ejection fraction. There were no differences in type and doses of medications, blood chemistry, and previous cardiac events" |
Groups received same intervention? | Unclear risk | Not reported |