An interventional study of DASH Diet plus Home-Based Exercise and Home-Based Exercise in Claudication and Peripheral Artery Disease, sponsored by University of Oklahoma. Recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Treatment
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.
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.
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's planned enrollment of 150 is above the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: DASH Diet plus 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.
Behavioral: 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 home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.
Peak Walking Time
The change in the time walked on a treadmill test
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
6-minute walk distance
The change in 6-minute walk distance from the pre-test value to the post-test value
Time frame: 3 months
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
Time frame: 3 months
Plan to share: No
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