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 |
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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 |
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Outcomes | Mortality | |
Comparison | Description: stayed on previous medication, continued sedentary lifestyle, and supervised by their private physicians | |
Country and setting | Germany Single centre |
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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" |