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. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4
Methods Parallel group RCT
Participants N Randomised: 73 (exercise 36; control 37)
Diagnosis (% of participants):
Aetiology: IHD 16%; DCM 84%
NYHA: Class I and II 74%; Class III 26%
LVEF: 29% (SD 9)
Case mix: 100% as above
Age (yr): exercise 54 (SD 9); control 54 (SD 8)
Male: 100% White: not reported
Inclusion/exclusion criteria
Inclusion: documented HF by signs, symptoms and angiographic evidence of reduced left ventricular function (LVEF < 40%) as a result of DCM or IHD; physical work capacity at baseline > 25 watts, clinical stability >=3 months before study start
Exclusion: significant valvular heart disease, uncontrolled hypertension, DM, hypercholesterolaemia, PVD, pulmonary disease, musculoskeletal abnormalities precluding exercise training
Interventions Exercise:Total duration: 6‐months
Aerobic/resistance/mix: aerobic
Frequency: 6 or 7 sessions/wk
Duration: 10‐20/session
Intensity: 70% of peak VO2
Modality: cycle ergometer
Setting: first 2 wk in hospital, remainder home based
Other: plus group sessions 1 hr twice weekly, walking, ball games and callisthenics
Outcomes Mortality
Comparison Continued individually tailored cardiac medications, supervised by their physicians
Country and setting Germany
Single centre
Follow‐up 6 months (after randomisation)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Patients were randomly assigned to either a training group or an inactive group sing a list of random numbers"
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 Not reported
Incomplete outcome data? Low risk QUORUM diagram and details of losses to follow‐up reported
Groups balanced at baseline? Low risk "No significant differences were observed between the two groups with regard to demographic or clinical data, including age, weight, LVEF, LVEDD [Left Ventricular End Diastolic Diameter], NYHA or maximum oxygen uptake"
Groups received same intervention? Unclear risk The co‐interventions in the control group not reported