Oxygen-guided Supervised Exercise Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorVA Office of Research and Development

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Supervised exercise therapy

Treatment groups

12 Participants
are divided into 2 treatment groups

Sponsors and collaborators

VA Office of Research and Development

Lead sponsor

University of Nebraska

Collaborator