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A community-based exercise program to improve walking outcomes in patients with peripheral artery disease

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Patients with peripheral artery disease (PAD) have significant walking impairment and a decreased quality of life. This is in part due to the classic symptom of PAD called claudication. Patients describe claudication as pain, aching, and cramping in the leg muscles during walking that goes away with rest. Walking exercise in supervised hospital settings is a primary therapy, however, these programs are unavailable due to a number of issues (e.g., no reimburesement, proximity to clinics). Programs of exercise in community settings are ineffective, largely due to primarily advice given by providers for patients to go home and walk. Thus, successful community-based walking exercise programs for PAD are needed. We will test the hypothesis that PAD patients randomized to an exercise program in the community setting incorporating training, monitoring, and coaching (TMC) components commonly used in supervised exercise programs will improve peak walking time (PWT) (the length of time a patient can walk on a graded treadmill) compared with control group patients who only receive the standard of care (upfront advice to walk). Secondary hypotheses include a significant improvement in patient perceived quality of life and a significant increase in volume of physical activity for patients who complete community-based walking exercise when compared with controls. Exploratory hypotheses include an improvement in PWT for patients who receive community exercise in addition to revascularization (a procedure that opens up the arteries of the legs; a standard treatment composed of endovascular therapy or open surgery for PAD provided separately from this study). Specifically, we will explore 1) patients receiving a combination of endovascular therapy (e.g., stenting, angioplasty) and community-based walking exercise, 2) open surgery and community-based walking exercise and compare outcomes to 3) patients who do not receive endovascular therapy or open intervention regardless of randomization to exercise or control groups.

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This study is NOT accepting healthy volunteers

Peripheral Artery Disease

claudication, community walking exercise, community-based participatory research, endovascular therapy, exercise adherence

Ryan Mays - rjmays@umn.edu
Ryan Mays
Clinical Outcomes Research
1612M01961
NCT02075502
See this study on ClinicalTrials.gov

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