Intermittent claudication is common in older individuals and often substantially limits physical activity. Physical activity levels in the elderly strongly predict cardiovascular and other morbidity. Despite claudication's prevalence, there remains controversy regarding the roles of revasculanzation and exercise therapy to improve physical functioning. The BROAD, LONG-TERM OBJECTIVE of the proposal is to optimize physical functioning, increase activity levels, and reduce cardiovascular disease risk in older individuals with peripheral arterial disease.
The SPECIFIC AIM of the proposed trial is to test the primary hypothesis that aortoiliac stenting/pharmacotherapy improves maximum walking duration (MWD) better than supervised exercise rehabilitation/exercise maintenance/pharmacotherapy for those with aortoiliac artery obstruction at 6 months.
Other aims are to compare these two treatment groups with a third group, usual care/pharmacotherapy, at 6 months, and to compare all 3 groups with regard to the following variables: MWD change score at 18 months, changes in free-living daily activity levels, patient-perceived quality of life, and cost-effectiveness. We also will perform exploratory analyses of demographic and biochemical risk factors for atherosclerosis, including BMI, blood pressure, lipid profile, HgbAlc, fibrinogen, and C-reactive protein. The HEALTH-RELATEDNESS of this project is that claudication is common in older individuals will increase in prevalence as our population ages, is chronic, and disabling. It limits physical activity and thereby increases cardiovascular disease risk. Optimum therapy is controversial, and varies by region and practitioner. The RESEARCH DESIGN AND METHODS is to divide 246 patients (at 9 study sites) with aortoiliac insufficiency and intermittent claudication randomly into 3 groups: usual care/pharmacotherapy, exercise rehabilitation/maintenance/pharmacotherapy, and stent/pharmacotherapy. Recruitment will be done over 28 months and patients will be followed for 18 months;the total study duration will be 5 years.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project--Cooperative Agreements (U01)
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Clinical Trials Review Committee (CLTR)
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Goldberg, Suzanne H
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Rhode Island Hospital
United States
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