Community-based exercise program for patients after revascularization for PAD
Community-based Exercise to Improve Physical Functioning and Cardiovascular Health Following Revascularization for Peripheral Artery Disease
NA · University of Minnesota · NCT04252950
This study is testing if a community-based exercise program can help people with peripheral artery disease feel better and improve their health after they have had surgery to restore blood flow.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT04252950 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a community-based structured exercise therapy (CB-SET) for patients with peripheral artery disease (PAD) who have undergone revascularization. Participants will be divided into two groups: one receiving supervised exercise training for one week followed by 11 weeks of community-based exercise, and the other receiving only verbal advice to exercise. The study will monitor participants' activity levels using accelerometers to assess compliance and outcomes related to cardiovascular health and functional improvement. The goal is to determine if the structured exercise program provides additional benefits compared to standard advice.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing revascularization for aorto-iliac and/or femoral-popliteal disease who can participate in an exercise program.
Not a fit: Patients with lower extremity amputations, critical limb ischemia, or other significant comorbidities limiting exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the functional capacity and cardiovascular health of PAD patients after revascularization.
How similar studies have performed: Previous studies have shown success with community-based exercise interventions for similar patient populations, suggesting potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Ryan Mays, PhD, MPH, MS — University of Minnesota
- Study coordinator: Courtney Farland-Johnson, MS
- Email: farla128@umn.edu
- Phone: 612-626-9551
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.
Conditions: Peripheral Artery Disease, PAD, peripheral artery disease, claudication, revascularization, community-based exercise