NCT04252950 Community-based Exercise Following Revascularization for PAD
| NCT ID | NCT04252950 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Peripheral Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-04-08 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-04-08 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary goal of this clinical trial is to evaluate whether a community-based structured exercise therapy (CB-SET) intervention, which could be accessible and easily disseminated, adds benefit to peripheral artery disease (PAD) patients undergoing revascularization (REVASC) to improve their function and cardiovascular health.
Eligibility Criteria
Inclusion Criteria: * Patients receiving Revascularization for aorto-iliac and/or femoral-popliteal disease in at least one limb * Patients with focal and/or diffuse peripheral artery disease * Bilateral Revascularization patients will also be included * Ability to participate in an exercise program Exclusion Criteria: * Lower extremity amputation(s) which interfere(s) with walking on the treadmill * Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities * PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis). * Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening * Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure * Individuals who have had a myocardial infarction within 3 months prior to screening * Individuals who have had a transient ischemic attack or stroke 3 months prior to screening * Individuals with uncontrolled hypertension (≥180 systolic or ≥100 diastolic resting blood pressure) during screening * Treatment with pentoxifylline or cilostazol for the treatment of claudication 4 weeks prior to screening. Patients can be reconsidered for study inclusion following a 1-month washout period * Poorly controlled diabetes defined as glycated hemoglobin \>12% * Abnormal results of blood work not conducive to safely participate in an exercise trial (e.g., anemic, electrolyte abnormalities) * Inability to speak English * Other clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study
Contact & Investigator
Ryan Mays, PhD, MPH, MS
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT04252950 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 90 Years, studying Peripheral Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04252950 currently recruiting?
Yes, NCT04252950 is actively recruiting participants. Contact the research team at farla128@umn.edu for enrollment information.
Where is the NCT04252950 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT04252950 clinical trial?
NCT04252950 is sponsored by University of Minnesota. The principal investigator is Ryan Mays, PhD, MPH, MS at University of Minnesota. The trial plans to enroll 30 participants.