WINSTON-SALEM, NC -- Cardiologists at Wake Forest University Baptist Medical Center are helping to lead an international study involving 83 other sites that will test 3,000 patients to determine whether exercise really is good for heart failure patients and whether exercise programs should be covered by Medicare and Medicaid services.
Though 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,” writes Dr. Dalane Kitzman, a cardiologist who is principal investigator at Wake Forest Baptist, in the American Heart Journal.
Controlled clinical trials have shown that exercise training improves physiological measurements such as the distance that patients can walk in six minutes. However, none of these trials enrolled a sufficient number of patients to properly evaluate the effect of exercise training on death and hospitalization, according to the study’s authors.
“The patient population enrolled in this trial will be a broad representation of heart failure patients, including large numbers of women, minorities and people from low socio-economic status,” says Kitzman. “The trial has been designed so that if the intervention is beneficial, the treatment can be translated rapidly into general practice.”
In fact, the researchers have met with the Centers for Medicare and Medicaid Services, the office that assesses whether there is enough proof that a treatment is effective and safe to be paid for by Medicare, to help ensure that exercise programs would qualify for Medicare if the study is positive.
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’ll come back for facility-based training every three months.
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.
“Five million Americans have heart failure with 550,000 new cases diagnosed each year. Despite optimal drug treatment, many heart failure patients die and others are faced with repeated hospitalizations, and have difficulty getting around, even for a few steps,” says Vinay Thohan, MD, director of the heart failure service at Wake Forest Baptist. “Exercise training represents an intervention that if proven beneficial, should be accessible to most heart failure patients due to its relatively low cost, high availability and ease of use.”