RECRUITING

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Talk to us

Conditions

ClaudicationPeripheral Artery Disease

Quick Navigation

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

This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the DASH dietary program combined with a home-based exercise program, quantified by a step activity monitor, to improve exercise and vascular outcome measures in patients with PAD.

Official Title

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Quick Facts

Study Start:2024-09-16
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03845036

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:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. History of claudication,
  2. 2. Presence of PAD, defined by meeting at least one of the following criteria (ABI at rest \< 0.90, or \> 20% decrease in ABI following a heel-rise exercise test in patients with a normal ABI at rest (\> 0.90), or history of peripheral revascularization.
  1. 1. absence of PAD, defined by meeting all of the following 3 criteria (ABI at rest \> 0.90), \< 20% decrease in ABI following a heel-rise exercise test, and no history of peripheral revascularization,
  2. 2. non-compressible vessels (ABI \> 1.40),
  3. 3. rest pain due to PAD (Fontaine stage III; Rutherford Grade II),
  4. 4. tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III),
  5. 5. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
  6. 6. peripheral revascularization within one month prior to investigation,
  7. 7. active cancer,
  8. 8. end stage renal disease defined as stage 5 chronic kidney disease,
  9. 9. medical conditions that are contraindicative for exercise according to the American College of Sports Medicine,
  10. 10. cognitive dysfunction (mini-mental state examination score \< 24), and
  11. 11. failure to complete the baseline tests within three weeks.

Contacts and Locations

Study Contact

Andrew Gardner, Ph.D.
CONTACT
405-271-4742
andrew-gardner@ouhsc.edu

Principal Investigator

Andrew Gardner, Ph.D.
PRINCIPAL_INVESTIGATOR
Professor, Department of Medicine, Cardiology

Study Locations (Sites)

O'Donoghue Research Building, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Andrew Gardner, Ph.D., PRINCIPAL_INVESTIGATOR, Professor, Department of Medicine, Cardiology

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 Date2024-09-16
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Claudication
  • Peripheral Artery Disease