Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale.
BACKGROUND: Although there are limited clinical data to support the use of exercise training as a means to reduce mortality and morbidity in patients with heart failure, current guidelines state that exercise is beneficial. TRIAL DESIGN: The objective of this trial is to determine whether exercise training reduces all-cause mortality or all-cause hospitalization for patients with left ventricular systolic dysfunction and heart failure symptoms. After undergoing baseline assessments to determine whether they can safely exercise, patients are randomized to either usual care or exercise training. Patients in the exercise training arm attend 36 supervised facility-based exercise training sessions. Exercise modalities are cycling or walking. After completing 18 sessions, patients initiate home-based exercise and then transition to solely home-based exercise after completing all 36 sessions. Patients return for facility-based training every 3 months to reinforce their exercise training program. Patients are followed for up to 4 years. Physiologic, quality-of-life, and economic end points that characterize the effect of exercise training in this patient population will be measured at baseline and at intervals throughout the trial. Blood samples will be collected to examine biomarkers such as brain natriuretic peptide, tumor necrosis factor, and C-reactive protein. CONCLUSIONS: Because of its relatively low cost, high availability, and ease of use, exercise training is an intervention that could be accessible to most patients with heart failure. The HF-ACTION trial is designed to definitively assess the effect of exercise training on the clinically relevant end points of mortality, hospitalization, and quality of life in patients with heart failure.
Whellan, DJ; O'Connor, CM; Lee, KL; Keteyian, SJ; Cooper, LS; Ellis, SJ; Leifer, ES; Kraus, WE; Kitzman, DW; Blumenthal, JA; Rendall, DS; Houston-Miller, N; Fleg, JL; Schulman, KA; Piña, IL; HF-ACTION Trial Investigators,
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