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The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Recruiting

Who can join

Ages 40 and older · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: University of Oklahoma · Participants: 150 · Started: Sep 16, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT03845036

Locations in the U.S.

OklahomaO'Donoghue Research Building, University of Oklahoma Health Sciences Center, Oklahoma City

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.