The international HF-ACTION trial is beginning enrollment of the 3,000 patients with heart failure who will be the basis for an analysis of the effects of exercise on this patient population, according to an article in the February issue of the American Heart Journal.

Although doctors have promoted the value of exercise for a variety of disorders for years, “exercise training has not been definitively established as safe in the group of patients who primarily have heart failure,” said Dalane W. Kitzman MD, the cardiologist who is principal investigator.

“Controlled clinical trials have shown that exercise training improves physiological measurements” such as the distance that patients can walk in six minutes, they said after analyzing 14 trials. “None of these trials enrolled a sufficient number of patients to properly evaluate the impact of exercise training on death and hospitalization.”

The new trial, called Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) “is the largest randomized clinical trial of exercise training ever performed,” Kitzman said. “The trial represents a critical step in establishing exercise as a therapy for patients with left ventricular dysfunction. The HF-ACTION trial has been designed so that if the intervention is beneficial, the treatment can be translated rapidly into general practice.”

There are 84 clinical study sites in the trial across North America and Europe. At the Wake Forest Baptist site, 120 participants have been enrolled so far, the second-highest number across all sites.

The patients in the study will receive either exercise training or usual care. Those in the exercise arm will receive 36 supervised exercise training sessions at a facility using either bikes or walking. After the first 18 sessions, the patients will start home-based exercise and will exercise exclusively at home after the second 18 sessions. They will return for facility-based training every three months.

The supervised training protocol is based on the traditional cardiac rehabilitation program of 36 sessions currently covered by insurers for patients after heart bypass surgery.

All patients in HF-ACTION will receive a self-management education program on topics such as medicines and their side effects, managing fluids, and the importance of adhering to a low sodium diet.

The patients will be followed for up to four years through clinic visits, specialized tests, and telephone calls. In their comparison of the two groups, the investigators will record deaths and hospitalizations for all causes. They’ll also measure changes in the maximum exercise time and quality of life.