Oxygen-guided exercise program for patients with peripheral artery disease
Official title: Oxygen-guided Supervised Exercise Therapy in Peripheral Artery Disease
Run by VA Office of Research and Development · NCT06003855 · Data updated 2026-11-12
This study tests a new exercise program that uses muscle oxygen levels to help people with peripheral artery disease walk better and feel healthier without the usual risks of traditional exercise.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Omaha, Nebraska) |
| Status | Recruiting |
| Started | October 1, 2023 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT06003855 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals with documented lower extremity arterial occlusive disease and a history of chronic claudication.
✕Probably not a fit
Patients experiencing rest pain or tissue loss due to PAD, or those with walking limitations from other conditions, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to assess the feasibility and acceptability of a muscle oxygen-guided supervised exercise program for patients suffering from peripheral artery disease (PAD). The intervention seeks to improve mobility and quality of life by allowing patients to engage in physical activity without the adverse effects associated with traditional supervised exercise therapy. By preventing cycles of ischemia and reperfusion during exercise, the study hopes to enhance walking performance and reduce cardiovascular risks. The research will compare the outcomes of this modified approach against standard exercise therapy.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the physical activity levels and overall health of patients with peripheral artery disease.
How similar studies have gone: While supervised exercise therapy is a common approach for PAD, this specific oxygen-guided intervention is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States Recruiting
Study contacts
- Principal investigator: Iraklis I Pipinos, MD — Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
- Study coordinator: Farahnaz Fallahtafti, PhD
- Email: ffallahtafti@unomaha.edu
- Phone: (402) 995-3542
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.