By Ed Susman
NEW ORLEANS -- November 11, 2008 -- Exercise training combined with optimal medical therapy can lead to reduced overall mortality and hospitalisation for heart failure patients, according to results of an international, phase 3, multicentre, randomised trial.
"We were able to show in this study that exercise is safe [in heart failure patients] and that there is a modest benefit in addition to all the benefit achieved by medications," said co-author Steven Keteyian, PhD, Division of Cardiovascular Medicine, Department of Internal Medicine, Henry Ford Hospital, Detroit, Michigan.
Results from A Randomized Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) in patients with heart failure should help convince doctors to "get by the dogma that 'you do not exercise these patients because you will harm them'," Dr. Keteyian said in a presentation on November 11.
In the HF-ACTION trial, the researchers enrolled 2,331 patients at 82 study sites throughout the United States, Canada, and France. Patients were randomised to receive usual care or usual care plus an exercise training program.
The exercise program consisted of mainly use of a treadmill or stationary bicycle or free walking, said Dr. Keteyian. After 18 sessions of training, the patients were then allowed to exercise unsupervised at home. Patients in the usual care group were asked to exercise about 30 minutes per day for 3 to 4 days weekly.
Enrolled patients had chronic heart failure, New York Heart Association Class II-IV, with a left ventricular ejection fraction of 35% or less, and were capable of exercising. Their average age was 59 years, and approximately one-third of the patients were women.
After an average of 2.5 years, researchers observed a 7% reduction in the primary endpoint of all-cause hospitalisation and death (P = .13).
When they adjusted for clinical characteristics strongly predictive of outcomes (ie, history of atrial fibrillation, depression, left ventricular ejection status) and the patient's initial capacity for exercise, the investigators found that exercise led to a significant 11% reduction in the risk of hospitalisation or death for those in the exercise group (P = .03).
About half the patients were able to maintain an exercise schedule that averaged about 74 minutes a week after 1 year.
During the study, 796 (68%) of patients in the usual care arm died or were hospitalised compared with 759 (65%) of patients in the exercise arm. There were 198 deaths in the usual care arm and 189 in the exercise arm (17% vs 16%, respectively).
"Exercise training confers clinical benefits without excess risk for heart failure patients," said Dr. Christopher O'Connor, MD, Duke Heart Center, Duke University Medical Center, Durham, North Carolina, during a press briefing.
"There was a real question in the literature as to whether these high-risk patients could safely attempt exercise training and whether doctors should prescribe exercise training for these patients outside of a highly supervised environment."
The discussant of the trial, Philip Poole-Wilson, MD, Imperial College, London, United Kingdom, said that despite the missed primary endpoint, "I find the data compelling. They do support the use of exercise in these patients."
"Before this study," Dr. Keteyian said, "doctors may have suggested exercise to heart failure patients. Now doctors can tell their patients 'you need to exercise'."
Funding for this study was provided in part by GE Healthcare and Roche Diagnostics.
[Presentation title: Efficacy and Safety of Exercise Training as a Treatment Modality in Patients With Chronic Heart Failure: Results of a Randomized Controlled Trial Investigating Outcomes of Exercise Training. Late breaking clinical trial 3318]
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