NCT03845036 The Effects of Diet and Exercise Interventions in Peripheral Artery Disease
| NCT ID | NCT03845036 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oklahoma |
| Condition | Claudication |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-09-16 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. History of claudication, 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. Exclusion Criteria: 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. non-compressible vessels (ABI \> 1.40), 3. rest pain due to PAD (Fontaine stage III; Rutherford Grade II), 4. tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III), 5. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation, 6. peripheral revascularization within one month prior to investigation, 7. active cancer, 8. end stage renal disease defined as stage 5 chronic kidney disease, 9. medical conditions that are contraindicative for exercise according to the American College of Sports Medicine, 10. cognitive dysfunction (mini-mental state examination score \< 24), and 11. failure to complete the baseline tests within three weeks.
Contact & Investigator
Andrew Gardner, Ph.D.
PRINCIPAL INVESTIGATOR
Professor, Department of Medicine, Cardiology
Frequently Asked Questions
Who can join the NCT03845036 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Claudication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03845036 currently recruiting?
Yes, NCT03845036 is actively recruiting participants. Contact the research team at andrew-gardner@ouhsc.edu for enrollment information.
Where is the NCT03845036 trial being conducted?
This trial is being conducted at Oklahoma City, United States.
Who is sponsoring the NCT03845036 clinical trial?
NCT03845036 is sponsored by University of Oklahoma. The principal investigator is Andrew Gardner, Ph.D. at Professor, Department of Medicine, Cardiology. The trial plans to enroll 150 participants.