RecruitingNot ApplicableNCT03845036

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Sponsor

University of Oklahoma

Enrollment

150 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

Claudication Peripheral Artery Disease

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

Min Age: 60 Years

Inclusion Criteria2

History of claudication,
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 Criteria11

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,
non-compressible vessels (ABI \> 1.40),
rest pain due to PAD (Fontaine stage III; Rutherford Grade II),
tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III),
use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
peripheral revascularization within one month prior to investigation,
active cancer,
end stage renal disease defined as stage 5 chronic kidney disease,
medical conditions that are contraindicative for exercise according to the American College of Sports Medicine,
cognitive dysfunction (mini-mental state examination score \< 24), and
failure to complete the baseline tests within three weeks.

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Interventions

BEHAVIORALDASH Diet plus Home-Based Exercise

The DASH dietary program consists of a diet emphasizing foods rich in fruits, vegetables, whole grains, and low-fat dairy, in which patients record daily servings of fruits and vegetables. The home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.

BEHAVIORALHome-Based Exercise

The home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.