RECRUITING

Community-based Exercise Following Revascularization for PAD

Conditions

Peripheral Artery Disease PAD claudication revascularization community-based exercise

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-04-08

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04252950

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.

Ages Eligible for Study:40 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Courtney Farland-Johnson, MS

CONTACT

612-626-9551

farla128@umn.edu

Principal Investigator

Ryan Mays, PhD, MPH, MS

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

University of Minnesota

Minneapolis, Minnesota, 55455

United States

Collaborators and Investigators

Sponsor: University of Minnesota

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-08

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2022-04-08

Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

PAD
peripheral artery disease
claudication
revascularization
community-based exercise

Additional Relevant MeSH Terms

Peripheral Artery Disease