Methods | Parallel group RCT | |
Participants |
N Randomised: 21 (exercise 15; control 6) Diagnosis (% of participants): Aetiology: ischaemic 71%; non‐ischaemic 29% NYHA: Class II 39%; Class III 52%; Class IV 9% LVEF: exercise 27.9% (SD 7.0); control 29.7% (SD 8.7) Case mix: 100% as above Age (yr): exercise 66.3 (SD 9.6); control 66 (SD 12.6) Male: 90% White: 100% Inclusion/exclusion criteria Inclusion: able to speak and read English; stable NYHA Class II‐IV no change in medical therapy for 30 days; resting LVEF < 40% measured by echocardiography or gated equilibrium radionuclide angiography; medical diagnosis of HF either ischaemic or non‐ischaemic; and standard pharmacological therapy for HF (diuretics, angiotensin‐converting enzyme inhibitors and beta‐blockers) Exclusion: participation in a formal exercise programme < 30 days prior to this study; clinical evidence decompensated HF; and any of the following medical conditions: AF, acute MI < 3 months, unstable angina pectoris, end‐stage renal disease or orthopaedic impediments to exercise |
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Interventions |
Exercise:Total duration: 24 wk Aerobic/resistance/mix: mix Frequency: 3 sessions/wk Duration: 30 min aerobic, 20 min resistance Intensity: 60‐85% max VO2, 12‐14 Borg scale Modality: aerobic: treadmill, stationary bike, rower, arm ergometer; resistance: light upper‐body exercises (military press, biceps curl and lateral deltoid raises) and lower‐body exercises (knee extension, side hip raise and hip extension) with 1‐10 lb hand and ankle weights. Wall push‐ups, abdominal curl‐ups, pelvic tilts, or a combination Setting: first 12 wk at the hospital and remaining sessions were unsupervised at rehabilitation centre Other: strategies from social learning theory (goal‐setting, feedback and problem‐solving guidance) utilised to facilitate, improve adherence to the training programme |
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Outcomes | Mortality | |
Comparison | Usual medical care | |
Country and setting | USA 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 | Outcomes described in methods are reported in results |
Intention‐to‐treat analysis? | Low risk | Although not stated, groups appear to analysed according to initial randomised allocation |
Incomplete outcome data? | Low risk | "One subject in the control group died of myocardial infarction and one subject in the exercise training group was diagnosed with cancer and unable to continue the exercise training."No imputation undertaken |
Groups balanced at baseline? | Low risk | "Subjects did not differ in fatigue or dyspnea by type of HF (ischemic vs. nonischemic) or years since diagnosis of HF (length of time since diagnosis)" |
Groups received same intervention? | Unclear risk | Not reported |