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 in the April 8 issue of the Journal of the American Medical
Association, 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 the
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 2,331 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 arrhythmias. 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 an average three-point gain on the KCCQ score and those
in the exercise group showing an average five-point gain (p <.001 for
difference between the groups). Previous reports had defined a five-point gain
as clinically significant.

Researchers
also looked at how individual patients responded to exercise training and found
that a higher percentage of those in the exercise group experienced clinical
meaningful improvement. 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 < .001).

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. Arrhythmias
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 five 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;  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, National Heart, Lung, and Blood
Institute.