Oxygen-guided Supervised Exercise Therapy
Recruiting now · Not applicable
Conditions studied: Peripheral Artery Disease
In brief
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.
Key facts
- Study ID
- NCT06003855
- Run by
- VA Office of Research and Development
- People needed
- 12
- Starts
- 2023-10-01
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2026-01-13
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska, United States (enrolling)
Full record on ClinicalTrials.gov
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