HF ACTION 2009.
| Methods | Parallel group RCT | |
| Participants |
N randomised: 2331 (exercise 1159, control 1172) Diagnosis (% of participants): Aetiology: IHD 51% NYHA: Class II 63%, Class III 35%, Class IV 1% LVEF: 25% (SD not reported) Case mix: 100%, as above Age, years: exercise 59 (SD not reported), control 59 (SD not reported) Male: 72% White: 62% Inclusion/exclusion criteria: Inclusion: LVEF < 35%; NYHA Class II to IV HF for previous 3 months despite a 6‐week period of treatment; optimal HF therapy at stable doses for 6 weeks before enrolment or documented rationale for variation, including intolerance, contraindication, participant preference, and personal physician's judgement; sufficient stability, by investigator judgement, to begin an exercise programme Exclusion: (selected) age < 18 years; co‐morbid disease or behavioural or other limitations that interfere with performing exercise training or preventing the completion of 1 year of exercise training; major cardiovascular event or cardiovascular procedure, including implantable cardioverter‐defibrillator use and cardiac re‐synchronisation, within previous 6 weeks |
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| Interventions |
Exercise: Total duration: 30 months Aerobic/resistance/mix: aerobic Frequency: 3 to 5 sessions/week Duration: 15 to 35 minutes/session Intensity: 60% to 70% HR reserve Modality: cycling or walking Setting: first 36 sessions were supervised, then participant was advised to follow a 5 days/week home‐based exercise programme Other: none reported Control group / Comparison: Usual care: all participants, regardless of group allocation, received self‐management educational materials consistent with guidelines of American College of Cardiology and American Heart Association |
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| Outcomes | Mortality, hospitalisation, HRQoL (KCCQ), cost‐effectiveness | |
| Country and setting | USA Multi‐centre |
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| Follow‐up | Median 30.1 months (after randomisation) | |
| Notes | Study authors were contacted for further details of outcome findings, but no information was provided Source of funding: Study authors were funded by various bodies, including National Institutes of Health and various pharmaceutical companies, particularly GE Medical and Roche |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The trial uses a permuted block randomization scheme stratified by center and by the etiology of the patient's heart failure (ischemic vs nonischemic)" |
| Allocation concealment (selection bias) | Low risk | "Patients are randomized at the enrolling centers using an interactive voice response" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Event outcomes were blinded |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods were reported in the results |
| Intention‐to‐treat analysis? | Low risk | "Statistical comparisons of the treatment arms with respect to clinical outcomes were performed according to the intention‐to‐treat principle" |
| Incomplete outcome data? | Low risk | QUORUM diagram and details of losses to follow‐up were reported |
| Groups balanced at baseline? | Low risk | Table 1 of the publication shows that the 2 groups were well balanced |
| Groups received same intervention? | Low risk | "All patients, regardless of group allocation, received self‐management educational materials...consistent with guidelines of American College of Cardiology and American Heart Association" |