Oxygen-guided exercise program for patients with peripheral artery disease
Oxygen-guided Supervised Exercise Therapy in Peripheral Artery Disease
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT06003855 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with documented lower extremity arterial occlusive disease and a history of chronic claudication.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Omaha, Nebraska
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.