Community-based Exercise Following Revascularization for PAD
Community-based Exercise to Improve Physical Functioning and Cardiovascular Health Following Revascularization for Peripheral Artery Disease
University of Minnesota
30 participants
Apr 8, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria13
- 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
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Interventions
Community-based structured exercise therapy (CB-SET) programs for PAD have potential merit as an alternative to hospital-based SET, as they may provide similar benefit to hospital-based programs but in a convenient location for the exercise to be completed
Endovascular revascularization is a primary treatment option for patients with PAD
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04252950