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 (yr): exercise 59 (SD not reported); control 59 (SD not reported) Male: 72% White: 62% Inclusion/exclusion criteria Inclusion: LVEF < 35%, NYHA Class II‐IV HF for the previous 3 months despite a 6‐wk period of treatment, optimal HF therapy at stable doses for 6 wk before enrolment or documented rationale for variation, including intolerance, contraindication, participant preference and personal physicians judgement, sufficient stability, by investigator judgement, to begin an exercise programme Exclusion: (selected) age <18 yr, co‐morbid disease or behavioural or other limitations that interfere with performing exercise training or prevent the completion of 1 yr of exercise training, major cardiovascular event or cardiovascular procedure, including implantable cardioverter defibrillator use and cardiac resynchronisation, within the previous 6 wk
Interventions	Exercise:Total duration: 30 months Aerobic/resistance/mix: aerobic Frequency: 3‐5 sessions/wk Duration: 15‐35 min/session Intensity: 60‐70% of HR reserve Modality: cycling or walking Setting: First 36 sessions were supervised then advised to follow 5 day/wk home‐based exercise programme Other: none reported
Outcomes	Mortality, hospitalisation, HRQoL (KCCQ), cost‐effectiveness
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
Country and setting	USA Multicentre
Follow‐up	Median 30.1 months (after randomisation)
Notes	Authors contacted for further details of outcome findings but no information provided
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 methods reported in results
Intention‐to‐treat analysis?	Low risk
Incomplete outcome data?	Low risk	QUORUM diagram and details of losses to follow‐up reported
Groups balanced at baseline?	Low risk	Table 1 of the publication shows 2 groups are 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"