RECRUITING

Oxygen-guided Supervised Exercise Therapy

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

Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic atherosclerosis, which blocks the leg arteries and results in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgery service at the Omaha Veterans' Affairs Medical Center. PAD also accounts for one-third of the operations performed in the VA Medical Centers nationwide. This project aims to establish the feasibility and acceptability of a muscle oxygen-guided supervised exercise program for patients with PAD. The investigators will determine the potential benefits of using this intervention over standard supervised exercise therapy. This modified intervention may enable patients to increase overall physical activity without the negative impacts on muscle structure and function. Increasing physical activity will decrease cardiovascular morbidity and mortality. If proven beneficial, the findings will lead to an improved exercise program that directly benefits veterans nationwide.

Official Title

Oxygen-guided Supervised Exercise Therapy in Peripheral Artery Disease

Quick Facts

Study Start:2023-10-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06003855

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:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be able to give written, informed consent
  2. * Have documented lower extremity arterial occlusive disease based on ankle/brachial index measurements and/or arterial imaging
  3. * Demonstrate positive history of chronic claudication
  4. * Have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks
  1. * Rest pain or tissue loss due to PAD (Fontaine stage III and IV)
  2. * Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
  3. * Walking capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology

Contacts and Locations

Study Contact

Farahnaz Fallahtafti
CONTACT
(402) 995-3542
Farahnaz.Fallahtafti@va.gov
Sara A Myers, PhD
CONTACT
(402) 554-3246
Sara.Myers2@va.gov

Principal Investigator

Iraklis I Pipinos, MD
PRINCIPAL_INVESTIGATOR
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Study Locations (Sites)

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Iraklis I Pipinos, MD, PRINCIPAL_INVESTIGATOR, Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

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 Date2023-10-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • peripheral arterial disease
  • atherosclerosis
  • arterial occlusive disease
  • gait

Additional Relevant MeSH Terms

  • Peripheral Artery Disease