Community-based Exercise Following Revascularization for PAD

Description

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.

Conditions

Peripheral Artery Disease

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Study Overview

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Study Details

Study overview

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.

Community-based Exercise to Improve Physical Functioning and Cardiovascular Health Following Revascularization for Peripheral Artery Disease

Community-based Exercise Following Revascularization for PAD

Condition
Peripheral Artery Disease
Intervention / Treatment

-

Contacts and Locations

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

40 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Minnesota,

Ryan Mays, PhD, MPH, MS, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2025-08-31