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NCT Number: NCT03845036

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Oklahoma City, Oklahoma, 73117, United States

Location status: Recruiting

Location contact

Andrew W Gardner, PhD

CONTACT

[email protected]

405-271-4742

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

DASH Diet plus Home-Based Exercise

Behavioral

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 Exercise

Behavioral

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.

Primary outcomes

  1. Peak Walking Time

    Time frame: 3 months

    The change in the time walked on a treadmill test

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

    Time frame: 3 months

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

Secondary outcomes

  1. calf muscle oxygen saturation

    Time frame: 3 months

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

  2. 6-minute walk distance

    Time frame: 3 months

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

  3. high-sensitivity C-reactive protein

    Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Gardner, Ph.D.

CONTACT

[email protected]

405-271-4742

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Case Western Reserve University
  • Milton S. Hershey Medical Center
  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Feb 19, 2019
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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