WITHDRAWN

Improving Exercise Rehabilitation Efficacy Outcomes Veterans Peripheral Artery Disease

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

Physical activity is the most beneficial and cost-effective treatment for Veterans with PAD, however, issues with oxygen delivery and utilization dramatically impair exercise compliance. The cause of these oxygen delivery and utilization impairments is likely increased oxidative stress and inflammation. The proposed project will comprehensively examine the novel strategy of Nuclear Factor Erythroid-2-like 2 (Nrf2) activation using PB125, aimed at diminishing oxidative stress and inflammation, and thereby lessening the negative impacts of the disease. This therapeutic will be evaluated in isolation and in combination with exercise rehabilitation to determine if there is a complimentary benefit. The ultimate goal is to provide insight into a potential novel therapeutic treatment for this disease, therefore, improving exercise tolerance and quality of life in this growing population.

Official Title

Improving Exercise Rehabilitation Efficacy and Outcomes in Veterans With Peripheral Artery Disease: Targeting Oxidative Stress and Inflammation

Quick Facts

Study Start:2023-07-03
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:WITHDRAWN

Study ID

NCT05648630

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 40 and older with clinically diagnosed femoropopliteal PAD (ankle-brachial index \< 0.9)
  2. * Must understand the study requirements and be willing and able to sign an informed consent document
  3. * Patients with mild cognitive impairment (i.e., montreal cognitive assessment (MOCA) \<26) will be included but must have a responsible caregiver or spouse present during the informed consent
  4. * Women that are not pregnant, breastfeeding, or likely to become pregnant within the next 6 months
  1. * Patients with a bleeding disorder that would contraindicate the performance of a muscle biopsy, such as a history of clinically significant bleeding diathesis (i.e., Hemophilia A or B, Von Willebrand's Disease, or congenital Factor VII deficiency)
  2. * Patients with a complex atherosclerotic lesion such that withholding medication creates disproportionate risk
  3. * Women currently taking hormone replacement therapy
  4. * Any other condition or event considered exclusionary by the PI and faculty physician

Contacts and Locations

Principal Investigator

David W. Wray, PhD
PRINCIPAL_INVESTIGATOR
VA Salt Lake City Health Care System, Salt Lake City, UT

Study Locations (Sites)

University of Utah Dept of Vascular Surgery
Salt Lake City, Utah, 84132
United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • David W. Wray, PhD, PRINCIPAL_INVESTIGATOR, VA Salt Lake City Health Care System, Salt Lake City, UT

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 Date2023-07-03
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2023-07-03
Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

  • inflammation (D007249)
  • Skeletal muscle (D018482)
  • Antioxidants (D000975)

Additional Relevant MeSH Terms

  • Peripheral Artery Disease (D058729)
  • Oxidative Stress (D018384)
  • Inflammation (D007249)