Supervised Exercise Therapy for Peripheral Arterial Disease
(MOMET Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it requires that your blood pressure, lipid, and diabetes medications be stable for 6 weeks before joining.
What data supports the effectiveness of the treatment Supervised Exercise Therapy for Peripheral Arterial Disease?
Is supervised exercise therapy safe for humans?
How is Supervised Exercise Therapy different from other treatments for peripheral arterial disease?
Research Team
Iraklis I Pipinos, MD
Principal Investigator
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Eligibility Criteria
This trial is for veterans with Peripheral Arterial Disease (PAD) who can consent, have documented artery blockages in their legs, and experience leg pain when walking. They must be on stable medication regimens for blood pressure, cholesterol, and diabetes. It's not for those with severe PAD causing rest pain or tissue loss, recent ischemic events due to clots or trauma, or walking issues caused by non-PAD conditions.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either standard supervised exercise therapy (SET) or oxygen-guided supervised exercise therapy (M-SET) for 12 weeks, with sessions three times per week.
Follow-up
Participants are monitored for exercise outcomes, muscle biochemistry, and subject-reported preferences after the intervention.
Open-label extension (optional)
Participants may opt into continuation of exercise therapy long-term if proven beneficial.
Treatment Details
Interventions
- Supervised Exercise Therapy (Behavioral Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Dr. Grant Huang
VA Office of Research and Development
Acting Chief Research and Development Officer
PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences
Dr. Erica M. Scavella
VA Office of Research and Development
Chief Medical Officer since 2022
MD from University of Massachusetts School of Medicine
University of Nebraska
Collaborator
Michael Dixon
University of Nebraska
Chief Executive Officer since 2010
PhD in Molecular Biology
Dr. Makker
University of Nebraska
Chief Medical Officer since 2020
MD from University of Nebraska Medical School