Recruiting

Exercise

Sponsor:

University of Minnesota

Code:

NCT04252950

Conditions

Peripheral Artery Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

CB-SET

Revascularization

Study Details

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.

Conditions

Peripheral Artery Disease

Study ID

NCT04252950

Start date

Apr 8, 2022

Status verified date

Sep, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CB-SET Treatment

Participants randomized to this group will receive a community-based structured exercise therapy (CB-SET) along with the standard of care (revascularization)

active comparator: Control

Participants randomized to this group will receive standard of care (revascularization)

Interventions

CB-SET

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

Revascularization

Endovascular revascularization is a primary treatment option for patients with PAD

Primary outcome measure

  • Change in Peak Walking Time (PWT) [ Time Frame: Baseline, 12 weeks ]

Central Contacts and Locations

Central contacts

Ryan Mays, PhD, MPH, MS

612-625-0430rjmays@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Ryan Mays, PhD, MPH, MS

612-625-0430rjmays@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • PAD
  • peripheral artery disease
  • claudication
  • revascularization
  • community-based exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-09.