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 |