Clinical trial Recruiting at 1 site Interventional

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 typeInterventional
SexAll
Enrollment12 (estimated)
SponsorVA Office of Research and Development
Federal
Locations1 site (Omaha, Nebraska)
StatusRecruiting
StartedOctober 1, 2023
Main results expectedDecember 30, 2026
Study endsDecember 30, 2026
Registry record updatedJanuary 13, 2026
Trial IDNCT06003855 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.