The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

University of Oklahoma150 enrolled

Overview

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.

This study seeks to (1) compare the changes in 6-minute walk distance (6MWD) and physical function quality of life in patients with peripheral artery disease (PAD) following a combined intervention of the dietary approaches to stop hypertension (DASH) dietary program plus a home-based exercise program, and following a home-based exercise program alone; and (2) compare the changes in microvascular function and inflammation in patients following the combined DASH diet and home-based exercise program, and the home-based exercise program alone. The investigators hypothesize that the combined DASH diet and exercise program will result in greater increases in 6MWD and in the physical function quality of life than the exercise program alone. Further, it is hypothesized that the combined DASH diet and exercise program will result in greater improvements in calf muscle oxygen saturation \[StO2\] following exercise, and in high-sensitivity C-reactive protein (hsCRP\]) than the exercise program alone. The home-based exercise program consists of intermittent walking to moderate claudication pain in a home-based setting. The DASH dietary program consists of the dietary approaches to stop hypertension diet emphasizing foods rich in fruits, vegetables, whole grains, and low-fat dairy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Claudication Peripheral Artery Disease

Interventions

DASH Diet plus Home-Based ExerciseBEHAVIORAL

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.

Home-Based ExerciseBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

O'Donoghue Research Building, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

RECRUITING

Outcomes

Primary Outcomes

Peak Walking Time

The change in the time walked on a treadmill test

Time frame: 3 months

Physical Function subscale of quality of life from the Medical Outcomes Study Short-Form 36 questionnaire

The change in the Physical Function subscale from the pre-test value to the post-test value

Time frame: 3 months

Secondary Outcomes

calf muscle oxygen saturation

The change in the calf muscle oxygen saturation value during exercise from the pre-test value to the post-test value

Time frame: 3 months

6-minute walk distance

The change in 6-minute walk distance from the pre-test value to the post-test value

Time frame: 3 months

high-sensitivity C-reactive protein

The change in the high-sensitivity C-reactive protein value from the pre-test value to the post-test value

Time frame: 3 months

Central Contacts

Andrew Gardner, Ph.D.

CONTACT

405-271-4742 andrew-gardner@ouhsc.edu

Data from ClinicalTrials.gov

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