The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Peripheral Artery Disease Clinical Trial

Official title:

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03845036
• Other study ID #: 16383
• Secondary ID: R01AG070086-01A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: February 2024
• Source: University of Oklahoma
• Contact: Andrew Gardner, Ph.D.
• Phone: 405-271-4742
• Email: andrew-gardner[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	O'Donoghue Research Building, University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (4)

Lead Sponsor	Collaborator
University of Oklahoma	Case Western Reserve University, Milton S. Hershey Medical Center, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Gardner AW, Bright BC, Ort KA, Montgomery PS. Dietary intake of participants with peripheral artery disease and claudication. Angiology. 2011 Apr;62(3):270-5. doi: 10.1177/0003319710384395. — View Citation

Gardner AW, Parker DE, Montgomery PS, Blevins SM. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J Am Heart Assoc. 2014 Sep 18;3( — View Citation

Gardner AW, Parker DE, Montgomery PS, Scott KJ, Blevins SM. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation. 2011 Feb 8;123(5):491-8. doi: 10.1161/CI — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Walking Time	The change in the time walked on a treadmill test	3 months
Primary	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	3 months
Secondary	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	3 months
Secondary	6-minute walk distance	The change in 6-minute walk distance from the pre-test value to the post-test value	3 months
Secondary	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	3 months