Community-based Exercise Following Revascularization for PAD

NCT04252950 | Recruiting

• 1 other identifier: SON-2020-28532
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Peak Walking Time (PWT)

  Participants will perform graded exercise tests conducted on a treadmill with continuous electrocardiogram monitoring. Participants will run at a constant speed of 2.0 miles/hour, starting at 0% grade. Every 2 min the grade is increased 2% until maximal claudication limits exercise. PWT (reported in minutes) will be recorded as the maximal time a participant can walk on the treadmill before having to stop due to severe claudication (assessed using the Claudication Symptom Rating Scale which ranges from 1-5 with 1=no pain, 2=onset claudication, 3=mild, 4=moderate, and 5=severe).

  Baseline, 12 weeks

Secondary Outcomes (17)

• Change in Claudication Onset Time (COT)

  Baseline, 12 weeks

• Change in VO2max

  Baseline, 12 weeks

• Total Volume of Exercise

  12 weeks

• Adherence to Exercise

  12 weeks

• Change in Walking Impairment Questionnaire (WIQ) Distance Subcategory

  Baseline, 12 weeks

Study Arms (2)

CB-SET Treatment

EXPERIMENTAL

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

Behavioral: CB-SET; Procedure: Revascularization

Control

ACTIVE COMPARATOR

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

Procedure: Revascularization

Interventions

CB-SET BEHAVIORAL

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

CB-SET Treatment

Revascularization PROCEDURE

Endovascular revascularization is a primary treatment option for patients with PAD

CB-SET Treatment; Control

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ryan Mays, PhD, MPH, MS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Farland-Johnson, MS

CONTACT

612-626-9551; farla128@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: April 8, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)