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. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4
Methods Parallel group RCT
Participants N Randomised: 20 (exercise 10; control 10)
Diagnosis (% of participants):
Aetiology: IHD; DCM
NYHA: Class II 90%; Class III 10%
LVEF: exercise mean 26.1% (SD 6); control mean 24.7% (SD 8)
Case mix: 100% as above
Age (yr): exercise 55 (SD 6); control 53 (SD 9)
Male: 100% White: not reported
Inclusion/exclusion criteria
Inclusion: age < 70 yr with CHF (NYHA II to III) as result of DCM or IHD as assessed by cardiac catheterisation. All had clinical, radiological and echocardiographic signs of CHF and an LVEF 40% as assessed by ventriculography and clinically stable condition for > 3 months before enrolment
Exclusion: significant valvular heart disease, uncontrolled hypertension, peripheral vascular disease, pulmonary disease or musculoskeletal abnormalities precluding exercise training
Interventions Exercise:Total duration: 2 wk inpatient followed by 6 months as outpatient
Aerobic/resistance/mix: aerobic
Frequency: 7 sessions/wk
Duration: 20 min/session
Intensity: 70% symptom limited VO2 max
Modality: cycle ergometers
Setting: supervised sessions at hospital and home‐based unsupervised sessions
Other: expected to participate in 1 group training session (walking, callisthenics and non‐competitive ball games) of 60 min each wk. Participants were asked to exercise for 20 min/day at home
Outcomes Mortality
Comparison Continued their sedentary lifestyle and remained on their individually tailored cardiac medication supervised by their private physicians
Country and setting Switzerland
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 are reported in results
Intention‐to‐treat analysis? Low risk Although ITT analysis not reported, groups do appear to be analysed according to original randomised allocation
Incomplete outcome data? Low risk No loss to follow‐up
Groups balanced at baseline? Low risk "Patients in the training group and in the control group showed a significantly reduced left ventricular ejection fraction (training group: 26.1 ±3.1%, control group: 24.7± 2.4%; NS [not significant]) and exercise capacity as determined by peak oxygen uptake (training group: 20.3 ±1.0 ml/kg min, control group: 17.9 ±1.6 ml/kg min; P NS)"
Groups received same intervention? Unclear risk Details of co‐interventions not reported