Exercise training is safe in heart failure patients, does not significantly reduce hospitalization or death, but is associated with several improved clinical outcomes, even in those already receiving optimal medical care, researchers reported at the American Heart Association’s Scientific Sessions 2008. The Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) was presented as a late-breaking clinical trial.

The trial is the world’s largest study of exercise training versus usual care in heart failure (HF) patients, said Christopher M. O’Connor, M.D., principal investigator and director of the Heart Center and professor of medicine at Duke University Medical Center in Durham, N.C.

The U.S.-government-funded, randomized, Phase III trial followed 2,331 heart failure patients (average age 59) at 82 sites in the United States, Canada and Europe for an average of 2.5 years. The patients were randomized to an exercise training program aimed at increasing workout intensity and duration or to usual care, in which they were encouraged to exercise, but without any specific program.

Researchers found no excess risk for heart attack, arrhythmia (abnormal heart rhythm), angina (chest pain) or fractures in the exercise training group.

Although exercise training of heart failure patients was not associated with a statistically significant reduction of the primary endpoint of composite of all-cause hospitalization and death, the prespecified secondary analyses with adjustment for prespecified major prognostic factors revealed an 11 percent reduction (p-value = 0.03) in the study’s primary endpoint and a 15 percent (p-value = 0.03) reduction in the secondary endpoint of cardiovascular mortality and heart failure hospitalization compared to the usual care group.

The exercise group received a multi-stage, guided exercise program that began with 36 supervised training sessions with a goal of 30 minutes of exercise three times a week. At the 18th session, patients received a treadmill or exercise bicycle for home use, learned how to monitor their heart rate during exercise and were encouraged to try to complete five weekly exercise sessions of similar intensity and 40 minute duration.

The 36 supervised exercise sessions were modeled on the cardiac rehabilitation sessions provided to heart attack survivors, which are usually covered by insurance, O’Connor said. Patients in the usual care group received instructions based on the American College of Cardiology/American Heart Association recommendation to perform 30 minutes of moderate intensity exercise most days of the week.

An unusually high proportion of the patients received optimal medical care with more than 90 percent of them getting evidenced-based medical therapy for their heart disease. A significant number also had implantable cardioverter defibrillators (ICDs), devices that help maintain the heart’s rhythm, said David Whellan, M.D., M.H.S., co-principal investigator and associate professor of medicine (cardiology) at Thomas Jefferson Medical College in Philadelphia, Penn.

After three months in the study, 52 percent of the exercise group were exercising at least three times a week for 40 minutes, a percentage that held fairly steady through the first year and then dropped off slightly, Whellan said. The median exercise time was maintained from 76 minutes per week at three months to 74 minutes per week at one year. At the one-year follow-up, 25 percent of the patients in the exercise group reported completing five sessions per week, he said.

Forty percent of the trial participants were members of minority groups and 28 percent were women. O’Connor credited the diversity to the medical centers involved and the U.S. government’s encouragement for including populations that have traditionally been under represented in medical trials.

SOURCE American Heart Association

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