Recruiting

Diet & Exercise

Sponsor:

University of Oklahoma

Code:

NCT03845036

Conditions

Claudication

Peripheral Artery Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

DASH Diet plus Home-Based Exercise

Home-Based Exercise

Study Details

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.

Conditions

Claudication

Peripheral Artery Disease

Study ID

NCT03845036

Start date

Sep 16, 2024

Status verified date

Apr, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DASH 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.

active comparator: Home-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.

Interventions

DASH 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.

Home-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.

Primary outcome measure

  • Peak Walking Time [ Time Frame: 3 months ]
  • Physical Function subscale of quality of life from the Medical Outcomes Study Short-Form 36 questionnaire [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Contacts

More Information

Sponsor

University of Oklahoma

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-04-17.