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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG070086-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Milton S. Hershey Medical Center | OTHER |
| National Institute on Aging (NIA) | NIH |
| Case Western Reserve University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DASH Diet plus Home-Based Exercise | Experimental | 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. |
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| Home-Based Exercise | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DASH Diet plus Home-Based Exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Walking Time | The change in the time walked on a treadmill test | 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 6-minute walk distance | The change in 6-minute walk distance from the pre-test value to the post-test value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Gardner, Ph.D. | Contact | 405-271-4742 | andrew-gardner@ouhsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Gardner, Ph.D. | Professor, Department of Medicine, Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| O'Donoghue Research Building, University of Oklahoma Health Sciences Center | Recruiting | Oklahoma City | Oklahoma | 73117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21262997 | Result | 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. | |
| 25237048 | Result | 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. |
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| ID | Term |
|---|---|
| D007383 | Intermittent Claudication |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000073601 | Dietary Approaches To Stop Hypertension |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Prospective, randomized controlled clinical trial
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| Home-Based Exercise | Behavioral | 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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| 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 | 3 months |
| 21406424 | Result | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |