This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Peripheral arterial occlusive disease (PAOD) patients with critical limb-threatening ischemia have improved peripheral circulation following infrainguinal revascularization. Despite this hemodynamic benefit, little change in functional status occurs, and many patients have residual ambulatory dysfunction. The lack of functional improvement in revascularized patients may be due to extreme physical deconditioning secondary to their pre-existing critical limb-threatening ischemia. Therefore, we hypothesize that a program of aerobic exercise training is necessary to optimize ambulation, free-living daily physical activity, and health-related quality of life through the mechanisms of improved walking economy, cardiopulmonary function, and further gains in peripheral circulation. This randomized controlled clinical trial comparing an exercise group undergoing a program of graded treadmill walking, and a delayed-entry non-exercise control group will address the following two aims: (1) to determine whether a 3-month exercise rehabilitation program will improve claudication distances, free-living daily physical activity, and health-related quality of life of older, revascularized patients with PAOD, and (2) to determine whether the primary mechanisms by which exercise rehabilitation affects the above functional outcomes are through alterations in walking economy, peripheral circulation, and cardiopulmonary function. Eighty revascularized PAOD patients will be randomized and complete either the exercise group (N=40) or the delayed-entry non-exercise group (N=40). The 3-month exercise program will consist of graded treadmill walking 3 times per week with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 80% of exercise capacity. We believe this study will demonstrate that exercise rehabilitation is an important adjuvant to revascularization surgery to achieve clinically meaningful gains in ambulation, free-living daily physical activity, and quality of life in PAOD patients with critical limb-threatening ischemia.
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