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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 35%; DCM 65%
NYHA: Class II 65%; Class III 35%
LVEF: exercise mean 24% (SD 13); control mean 23% (SD 10%)
Case mix: as above
Age (yr): exercise 54 (SD 9); control 56 (8)
Male: 100% White: not reported
Inclusion/exclusion criteria
Inclusion: age < 70 yr, with CHF as a result of DCM or IHD, LVEF < 40%
Exclusion: DM, hypertension, overt atherosclerotic PVD, hypercholesterolaemia, ventricular tachycardia, COPD and primary valvular disease
Interventions Exercise:Total duration: 6 months
Aerobic/resistance/mix: aerobic
Frequency: 2‐6 sessions/day
Duration: 10‐20 min/session
Intensity: 70% VO2 max
Modality: bike ergometer
Setting: supervised hospital‐based sessions and unsupervised home‐based sessions
Other: not reported
Outcomes Mortality
Comparison Description: stayed on previous medication, continued sedentary lifestyle, and supervised by their private 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) 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 It appears that groups are analysed according to original randomised allocation
Incomplete outcome data? Low risk Detailed description of losses to follow‐up and drop‐outs reported
Groups balanced at baseline? Low risk "At baseline, patients in the control group did not differ significantly from those in the training group with respect to age, aetiology of heart failure, NYHA functional class, duration of heart failure, LVEF [lett ventricular ejection fraction] or LVEDD [Left Ventricular End Diastolic Diameter]"
Groups received same intervention? Low risk "Patients were on angiotensin‐converting enzyme inhibitors (100% in both groups), diuretics (training group 82%, control 70%), and digoxin (training 73%, control 70%, P5NS). Drug treatment did not change between 4 weeks before enrolment and study termination"