Actively Recruiting
Oxygen-guided Supervised Exercise Therapy
Led by VA Office of Research and Development · Updated on 2026-01-13
12
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
U
University of Nebraska
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Oxygen-guided Supervised Exercise Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give written, informed consent
- Documented lower extremity arterial occlusive disease confirmed by ankle/brachial index or arterial imaging
- Positive history of chronic claudication
- Stable blood pressure, lipid, diabetes regimens and controlled risk factors for at least 6 weeks
You will not qualify if you...
- Presence of rest pain or tissue loss due to PAD (Fontaine stage III and IV)
- Recent acute lower extremity ischemic event caused by thromboembolic disease or trauma
- Walking ability limited by other conditions than claudication such as joint, musculoskeletal, neurologic, heart, or lung diseases
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States, 68105-1850
Actively Recruiting
Research Team
F
Farahnaz Fallahtafti, PhD
CONTACT
S
Sara A Myers, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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