O'Donoghue Research Building, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117, United States
Location status: Recruiting
NCT Number: NCT03845036
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.
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Not applicable
Oklahoma City, Oklahoma, 73117, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months
The change in the time walked on a treadmill test
Time frame: 3 months
The change in the Physical Function subscale from the pre-test value to the post-test value
Time frame: 3 months
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
The change in 6-minute walk distance from the pre-test value to the post-test value
Time frame: 3 months
The change in the high-sensitivity C-reactive protein value from the pre-test value to the post-test value
Contact information is provided by the study sponsor or research team.
University of Oklahoma
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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