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Heart failure patients who regularly exercise fare better
and feel better about their lives than do similar patients who
do not work out on a regular basis, say researchers at Duke
University Medical Center.

The findings, reported today at the annual meeting of the
American Heart Association's Scientific Sessions 2008, go a
long way toward addressing concerns about the value of exercise
for the nation's five million patients with heart failure. They
also raise important policy questions for the country's
Medicare program and other insurers.

"Past studies have sent mixed signals about the merit of
exercise for patients with heart failure. The HF-ACTION study
(A Controlled Trial Investigating Outcomes Exercise TraiNing)
shows that exercise is not only safe for patients, but also
helps to improve the quality of their lives, overall," says
Kathryn Flynn, PhD, a health services researcher at Duke
Clinical Research Institute (DCRI) and lead author of the
study.

HF-ACTION is the largest clinical trial to date examining
the value of exercise in the treatment of heart failure.
Investigators enrolled 2331 patients with moderate to severe
heart failure at 82 sites throughout the U.S., Canada and
France from 2003 to 2008.

Funded by a $37 million grant from the National Heart,
Blood, and Lung Institute, researchers randomized participants
to receive either standard care or standard care plus an
exercise program. The exercise regimen consisted of three
months of supervised aerobic training on a bicycle or
treadmill, followed by instruction for continued home-based
training. Researchers set the exercise goal at five, 40-minute
workouts, or 200 minutes of exercise per week. Participants
reached about 60 percent of that goal at one year.

Participants had significant heart failure upon entering the
study, measured by diminished left ventricular ejection
fraction (mean, 25 percent). Ninety-five per cent of the
patients were taking medications for heart failure, such as
ACE-inhibitors or beta-blockers, and 40 percent were using
mechanical devices to boost their hearts' ability to pump or to
treat arrythmias. The average age of the patients was 59; 28
percent were women.

Upon enrollment, patients filled out the Kansas City
Cardiomyopathy Questionnaire (KCCQ), a 23-item measure shown to
be responsive to underlying clinical changes in patients with
heart failure. The KCCQ generated an overall measure of quality
of life and subscale measures reflecting the patients' physical
limitations, symptoms, quality of life and social restrictions.
Participants completed the questionnaire at three-month
intervals for the first 12 months, and annually thereafter. The
average time of follow-up was two and one-half years.

There were no significant differences between the two
patient groups at baseline. The average overall KCCQ score
among patients in both groups was 66.

At three months, patients in both groups showed improvement,
with patients in the usual care group registering a three-point
gain on the KCCQ score and those in the exercise group showing
a five-point gain (p =.0005). Previous reports had
defined a five-point gain as clinically significant.

Researchers also found that a higher percentage of those in
the exercise group experienced more robust gains. At three
months, 54 percent of those in the exercise group saw a
five-point gain in overall KCCQ score, while only 28 percent of
those in the usual care group met that goal. (p =
.0001).

Exercise group members consistently outscored those in the
usual care group on all subscale measures on the KCCQ, as well.
"And the best news is that while the gains were modest, they
were sustained over time," says Flynn.

During the study period, the incidence of adverse effects
was similar between the two groups. There were 41 heart attacks
among patients in the exercise arm and 45 heart attacks among
those receiving usual care. Arrythmias occurred in about 14
percent of the patients in each group.

Researchers say the findings are important because they
demonstrate that a relatively low-cost and readily available
intervention can significantly improve the quality of life for
heart failure patients, a finding that may be important for the
country's Medicare program, which currently does not pay for
exercise therapy for patients with heart failure.

"We found that a majority of those who exercised reported a
five-point improvement in the KCCQ scale. That means that they
experienced significant improvement in many aspects of their
day-to-day activities, such as working, walking, being able to
dress, bathe, and getting out to visit family and friends,"
says Ileana Piña, MD, a professor of medicine at Case Western
Reserve University and chair of the HF-ACTION Steering
Committee. Piña, who is a Quality Scholar at the Cleveland VA,
says clinicians should consider using the KCCQ inventory on a
regular basis. "It is a quick and easy method to find out
valuable information about patients' health status. It only
takes about eight minutes to fill out, which is a small burden
for patients."

"This study has important implications for the 5 million
Americans who have heart failure," noted Elizabeth G. Nabel,
MD, NHLBI director. "As the number of people affected by heart
failure is expected to rise with the aging U.S. population, it
is promising to know that regular aerobic activity can not only
help patients extend their lives, but exercise can also
positively impact their everyday activities and outlook."

Additional authors on the study include senior author, Kevin
Weinfurt, DCRI, Steven Keteyian, co-chair of the HF-ACTION
Steering Committee, Henry Ford Hospital; Kerry Lee, Christopher
O'Connor, Kevin Schulman, Li Lin, James Blumenthal, Stephen
Ellis, and William Kraus, from DCRI; David Whellan, Jefferson
Medical College; Nancy Houston Miller, Stanford University;
Jonathan Howlett, Dalhousie University; Dalane Kitzman, Wake
Forest University, John Spertus, Mid America Heart Institute;
and Lawrence Fine and Lawton Cooper; National Heart, Lung, and
Blood Institute.