- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03845036
The Effects of Diet and Exercise Interventions in Peripheral Artery Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrew Gardner, Ph.D.
- Phone Number: 405-271-4742
- Email: andrew-gardner@ouhsc.edu
Study Locations
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73117
- O'Donoghue Research Building, University of Oklahoma Health Sciences Center
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Contact:
- Andrew W Gardner, PhD
- Phone Number: 405-271-4742
- Email: andrew-gardner@ouhsc.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Function subscale of quality of life from the Medical Outcomes Study Short-Form 36 questionnaire
Time Frame: 3 months
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The change in the Physical Function subscale from the pre-test value to the post-test value
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3 months
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Peak Walking Time
Time Frame: 3 months
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The change in the time walked on a treadmill test
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6-minute walk distance
Time Frame: 3 months
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The change in 6-minute walk distance from the pre-test value to the post-test value
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3 months
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calf muscle oxygen saturation
Time Frame: 3 months
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The change in the calf muscle oxygen saturation value during exercise from the pre-test value to the post-test value
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3 months
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high-sensitivity C-reactive protein
Time Frame: 3 months
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The change in the high-sensitivity C-reactive protein value from the pre-test value to the post-test value
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3 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew Gardner, Ph.D., Professor, Department of Medicine, Cardiology
Publications and helpful links
General Publications
- 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/CIRCULATIONAHA.110.963066. Epub 2011 Jan 24.
- 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(5):e001107. doi: 10.1161/JAHA.114.001107.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16383
- R01AG070086-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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