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HF-ACTION Randomized Controlled Trial

Kathryn E. Flynn, PhD; Ileana L. Piña, MD; David J. Whellan, MD, MHS; Li Lin, MS; James A. Blumenthal, PhD; Stephen J. Ellis, PhD; Lawrence J. Fine, MD, DrPH; Jonathan G. Howlett, MD; Steven J. Keteyian, PhD; Dalane W. Kitzman, MD; William E. Kraus, MD; Nancy Houston Miller, RN, BSN; Kevin A. Schulman, MD; John A. Spertus, MD, MPH; Christopher M. O’Connor, MD; Kevin P. Weinfurt, PhD

JAMA. 2009;301(14):1451-1459.

Context  Findings from previous studies of the effects of exercise training on patient-reported health status have been inconsistent.

Objective  To test the effects of exercise training on health status among patients with heart failure.

Design, Setting, and Patients  Multicenter, randomized controlled trial among 2331 medically stable outpatients with heart failure with left ventricular ejection fraction of 35% or less. Patients were randomized from April 2003 through February 2007.

Interventions  Usual care plus aerobic exercise training (n = 1172), consisting of 36 supervised sessions followed by home-based training, vs usual care alone (n = 1159). Randomization was stratified by heart failure etiology, which was a covariate in all models.

Main Outcome Measures  Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary scale and key subscales at baseline, every 3 months for 12 months, and annually thereafter for up to 4 years. The KCCQ is scored from 0 to 100 with higher scores corresponding to better health status. Treatment group effects were estimated using linear mixed models according to the intention-to-treat principle.

Results  Median follow-up was 2.5 years. At 3 months, usual care plus exercise training led to greater improvement in the KCCQ overall summary score (mean, 5.21; 95% confidence interval, 4.42 to 6.00) compared with usual care alone (3.28; 95% confidence interval, 2.48 to 4.09). The additional 1.93-point increase (95% confidence interval, 0.84 to 3.01) in the exercise training group was statistically significant (P < .001). After 3 months, there were no further significant changes in KCCQ score for either group (P = .85 for the difference between slopes), resulting in a sustained, greater improvement overall for the exercise group (P < .001). Results were similar on the KCCQ subscales, and no subgroup interactions were detected.

Conclusions  Exercise training conferred modest but statistically significant improvements in self-reported health status compared with usual care without training. Improvements occurred early and persisted over time.

Trial Registration  clinicaltrials.gov Identifier: NCT00047437.

Author Affiliations: Duke Clinical Research Institute (Drs Flynn, Whellan, Ellis, Schulman, O’Connor, and Weinfurt and Ms Lin) and Departments of Psychiatry and Behavioral Sciences (Drs Flynn, Blumenthal, and Weinfurt) and Medicine (Drs Kraus, Schulman, and O’Connor), Duke University School of Medicine, Durham, North Carolina; Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio (Dr Piña); Department of Medicine, Jefferson Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania (Dr Whellan); Division of Prevention and Population Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland (Dr Fine); Department of Medicine, Stanford University, Stanford, California (Ms Houston Miller); Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, Nova Scotia, Canada (Dr Howlett); Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, Michigan (Dr Keteyian); Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina (Dr Kitzman); Mid America Heart Institute, Saint Luke's Health System, Kansas City, Missouri (Dr Spertus); and University of Missouri–Kansas City (Dr Spertus).

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