The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Not Applicable

Recruiting

• Conditions: Peripheral Artery Disease; Claudication
• Interventions: Behavioral: Home-Based Exercise; Behavioral: DASH Diet plus Home-Based Exercise

• Registration Number: NCT03845036
• Lead Sponsor: University of Oklahoma

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.

Detailed Description

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 Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Study Start: 2024-09-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-16
• Primary Completion: 2029-05-31
• Study Completion: 2029-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-Based Exercise	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.
DASH Diet plus Home-Based Exercise	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.

Primary Outcome Measures

Name	Time	Method
Physical Function subscale of quality of life from the Medical Outcomes Study Short-Form 36 questionnaire	3 months	The change in the Physical Function subscale from the pre-test value to the post-test value
Peak Walking Time	3 months	The change in the time walked on a treadmill test

Secondary Outcome Measures

Name	Time	Method
calf muscle oxygen saturation	3 months	The change in the calf muscle oxygen saturation value during exercise from the pre-test value to the post-test value
6-minute walk distance	3 months	The change in 6-minute walk distance from the pre-test value to the post-test value
high-sensitivity C-reactive protein	3 months	The change in the high-sensitivity C-reactive protein value from the pre-test value to the post-test value

Trial Locations

Locations (1)

O'Donoghue Research Building, University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States