HEARTS: Heart, Exercise, and Resistance Training Study

BACKGROUND:

The amount of functional skeletal muscle that CHF patients are able to preserve is a major
independent predictor of their ability to maintain physical function. Older patients with
CHF (who make up the vast majority of CHF patients) are least able to do this. The disease
is marked by a loss of aerobic muscle fibers, while aging is marked by a loss of glycolytic
muscle fibers. Because the disease may be physiologically different in older CHF patients
than in younger ones (due to loss of both muscle types in older CHF patients), they need
different therapeutic approaches. Strategy tests aimed at increasing muscle mass through
resistance strength training in systolic failure patients have been rare, small, and
generally lacking older participants. The studies done among younger CHF patients have shown
that both aerobic, and combination aerobic and strength training can increase work capacity,
oxidative muscle activity, and glycolytic muscle strength. Additionally, combination
training can improve cardiac measures, including LVEF.

DESIGN NARRATIVE:

An estimated 200 participants age 65 and older with Class II and III CHF and LVEF 20% to 40%
will be included in this study. Their work capacity will be measured in watts on a cycle
ergometer exercise stress test (Time 1). They will be randomized by gender, race, and
disease severity into two exercise groups: 1) resistance and aerobic training (RA); and 2)
aerobic training (A). Both groups will exercise three times a week for 4 months. At the end
of the 4 months of training, the cycle ergometer stress test will be repeated (Time 2). By
comparing changes in maximum watts achieved from Time 1 to Time 2 in each group, an
assessment can be made of the effectiveness of each exercise program in improving work
capacity. Secondarily, measures will be performed and compared of myocardial remodeling, leg
strength, and leg muscle oxidative capacity at Time 1 and Time 2. The goal of the study is
to determine the following:

1. If low resistance frequent repetition resistance training combined with aerobic
training increases aerobic work capacity more than pure aerobic training.

2. If any improvement in aerobic work capacity is due to changes in muscle fiber
composition, local blood flow, arterial endothelial function, or some combination.

The study completion date listed in this record was obtained from the "Completed Date"
entered in the Query View Report System (QVR).

Inclusion Criteria:

- Class II and III CHF that has been clinically stable for at least 6 months

- Systolic ejection fraction (LVEF) between 20% and 40%

- Under the care of a cardiologist who is willing to have the patient participate in
the study and who will continue to follow the patient medically during his/her
participation

- Willing and able to undergo the screening procedures and the 1 month observation
period to determine eligibility

- Willing and able to come to the research center three times a week for 4 months to
participate in an exercise program consisting of either aerobic exercise only, or
aerobic exercise plus resistance training

- Able to speak and read English

- Willing to participate in the study after having the study explained to him/her and
has signed an informed consent form

Exclusion Criteria:

- Eligible for a cardiac rehabilitation program under Medicare rules due to a recent
acute event

- Any medical condition that would make either exercise unsafe or uncomfortable, such
as symptomatic COPD, severe arthritis, severe peripheral vascular disease, unstable
heart disease, uncontrolled blood pressure, or neurological conditions

- Other complicating diseases, such as severe anemia or other blood dyscrasia affecting
function, chronic renal failure, progressive cancer, or unstable diabetes

- Does not otherwise meet the above inclusion criteria