Cardiovascular Diseases Clinical Trial
Official title:
Improving Functioning in Peripheral Arterial Disease
The purpose of this study is to compare the effects of nutrition, a supervised treadmill exercise program, and supervised progressive resistance training program on peripheral arterial disease.
BACKGROUND:
Previous work demonstrates that functional limitations associated with peripheral arterial
disease (PAD) are diverse and include slower walking speed, poorer walking endurance, and
impaired balance as compared to persons without PAD. Although treadmill-walking exercise
improves treadmill performance in patients with intermittent claudication (IC), treadmill
performance does not correlate well with community walking ability in older men and women.
In older patient populations without PAD, resistance training improves functioning and
walking endurance, but this mode of exercise has not been sufficiently studied in PAD.
Furthermore, although 65% to 70% of men and women with PAD are either asymptomatic or have
exertional leg symptoms other than IC, no prior studies have assessed the effects of
exercise interventions in PAD patients who do not have IC.
DESIGN NARRATIVE:
The randomized, control study will determine whether a 6-month supervised treadmill exercise
program and a supervised lower extremity progressive resistance training program,
respectively, improve lower extremity functioning compared to a nutrition control group
among 150 PAD patients with and without IC. The investigators hypothesize that participants
in the treadmill walking exercise program and participants in the progressive resistance
training program, respectively, will experience greater improvement in functional outcomes
than participants in the nutrition control group. The primary functional outcome measures in
descending order of importance are 6-minute walk distance and the summary performance score.
The summary performance score is a composite measure of lower extremity functioning (usual
walking speed, standing balance, and time required for five repeated chair rises) measured
on a 0-12 scale that predicts future risk of nursing home placement, mobility loss, and
mortality. The study will also identify mechanisms by which the exercise interventions
improve functioning in PAD. Mechanisms to be studied include changes in blood viscosity,
calf blood flow, brachial artery endothelial reactivity, and inflammatory cytokine levels.
By identifying the optimal exercise program for improving functioning in PAD patients with
and without IC, the findings will have substantial clinical and public health implications
for millions of patients with PAD.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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