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. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4
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)
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
Outcomes HRQoL (MLWHFQ); mortality; morbidity; cost‐effectiveness
Comparison Standard medical care
Country and setting Italy
Single centre
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