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RECRUITINGINTERVENTIONAL

Oxygen-guided Supervised Exercise Therapy

Oxygen-guided Supervised Exercise Therapy in Peripheral Artery Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic atherosclerosis, which blocks the leg arteries and results in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgery service at the Omaha Veterans' Affairs Medical Center. PAD also accounts for one-third of the operations performed in the VA Medical Centers nationwide. This project aims to establish the feasibility and acceptability of a muscle oxygen-guided supervised exercise program for patients with PAD. The investigators will determine the potential benefits of using this intervention over standard supervised exercise therapy. This modified intervention may enable patients to increase overall physical activity without the negative impacts on muscle structure and function. Increasing physical activity will decrease cardiovascular morbidity and mortality. If proven beneficial, the findings will lead to an improved exercise program that directly benefits veterans nationwide.

Who May Be Eligible (Plain English)

Who May Qualify: At entry into the study, all subjects must: - Be able to give written, willing to sign a consent form - Have documented lower extremity arterial occlusive disease based on ankle/brachial index measurements and/or arterial imaging - Demonstrate positive history of chronic claudication - Have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks Who Should NOT Join This Trial: Any potential subjects will be excluded if they have: - Rest pain or tissue loss due to PAD (Fontaine stage III and IV) - Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma - Walking capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: At entry into the study, all subjects must: * Be able to give written, informed consent * Have documented lower extremity arterial occlusive disease based on ankle/brachial index measurements and/or arterial imaging * Demonstrate positive history of chronic claudication * Have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks Exclusion Criteria: Any potential subjects will be excluded if they have: * Rest pain or tissue loss due to PAD (Fontaine stage III and IV) * Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma * Walking capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology

Treatments Being Tested

BEHAVIORAL

Supervised exercise therapy

Subjects will be enrolled in a 12-week intervention program of either modified supervised exercise therapy or standard supervised exercise therapy. The program will be 3 sessions/week for 12 weeks. Each session will consist of 50 minutes plus 5 minutes warm up and cool down.

Locations (1)

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States