The Effects of Diet and Exercise Interventions in Peripheral Artery Disease
NCT ID: NCT03845036
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-09-16
2029-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
60 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
National Institute on Aging (NIA)
NIH
Case Western Reserve University
OTHER
University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Andrew Gardner, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Professor, Department of Medicine, Cardiology
Locations
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O'Donoghue Research Building, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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16383
Identifier Type: -
Identifier Source: org_study_id
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