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. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4
Methods Parallel group RCT
Participants N Randomised: 50 (exercise 25; control 25)
Diagnosis (% of participants):
Aetiology: IHD 100%
NYHA: Class II: exercise 56%; control 60%; Class III: exercise 44%; control 40%
LVEF: exercise mean 27.4% (SD 5.7); control: 28.5% (SD 5.2)
Case mix: 100% as above
Age (yr): exercise 59.6 (SD 10.2); control 61.2 (SD 9.5)
Male: exercise 80%; control 72% White: not reported
Inclusion/exclusion criteria
Inclusion: ischaemic HF in NYHA Classes II and III of > 6 months, clinically stable > 6 wk and LVEF < 35%
Exclusion: uncontrolled arterial hypertension; history of major ventricular arrhythmias, acute coronary syndrome, percutaneous coronary intervention or brain event 3 months prior to the study; AF or other arrhythmia making it impossible to perform MRI; previous coronary artery bypass grafting; implantable cardiodefibrillator; permanent pacemaker or the presence of metal parts in the body; signs of osteoarticular dysfunction excluding participation in physical training; DM; COPD and anaemia
Interventions Exercise:Total duration: 6 months
Aerobic/resistance/mix: aerobic
Frequency: 3 sessions/wk
Duration: 25 min/session
Intensity: 80% predicted HR at VO2 max
Modality: cycling
Setting: centre‐based
Other: none reported
Outcomes Mortality
Comparison Standard medical care only
Country and setting Poland
Single centre
Follow‐up 26 wk (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? Low risk Not implicit but numbers used suggest that groups analysed according to randomised allocation
Incomplete outcome data? Low risk No participants lost to follow‐up
Groups balanced at baseline? Low risk "At baseline the groups did not differ significantly in clinical characteristics. The only exception was smoking, the training group consisted of significantly more ex‐smokers"
Groups received same intervention? Unclear risk Not reported