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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG024296 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Oklahoma Center for the Advancement of Science and Technology | OTHER |
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function.
This study seeks to 1) compare the changes in ambulatory function, vascular function, and health-related quality of life in patients limited by intermittent claudication following a home-based exercise rehabilitation program, a supervised exercise program, and a light resistance training exercise program; and 2) determine whether changes in walking efficiency, calf muscle circulation, and calf muscle oxygen are the reasons by which both home-based and supervised exercise rehabilitation improve ambulatory function.
We hypothesize that a home-based exercise program utilizing new physical activity monitoring technology that can accurately quantify exercise adherence as well as the intensity, duration, and volume of exercise sessions will result in similar changes in ambulatory function, vascular function, and health-related quality of life compared to a standard, supervised exercise program. Further, both the home-based and supervised exercise rehabilitation programs will result in greater changes in ambulatory function, vascular function, and health-related quality of life than a light resistance training exercise program. Finally, we hypothesize that the changes in walking efficiency, calf muscle circulation, and calf muscle oxygen will each be predictive of improved ambulation following the home-based exercise program as well as the supervised exercise program.
The 3-month program will consist of walking 3 times per week, with progressive increases in duration and intensity. The two walking exercise programs will be matched on the estimated caloric expenditure during the training sessions. Patients in the control group will perform light resistance training without any walking exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Home-based program with progressive increases in exercise duration and intensity (i.e., cadence); walking duration will be longer for the home-based group because the intensity of walking will be lower than the graded treadmill walking performed by the supervised group |
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| 2 | Experimental | Supervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 70% of exercise capacity |
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| 3 | Active Comparator | Light resistance training without any walking exercise |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking Exercise | Behavioral | Three times per week for 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in walking efficiency | 3 months | |
| Change in calf muscle circulation and calf muscle oxygen | 3 months | |
| Change in health-related quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew W Gardner, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Center, University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7674529 | Background | Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80. | |
| 11454114 | Background | Gardner AW, Katzel LI, Sorkin JD, Bradham DD, Hochberg MC, Flinn WR, Goldberg AP. Exercise rehabilitation improves functional outcomes and peripheral circulation in patients with intermittent claudication: a randomized controlled trial. J Am Geriatr Soc. 2001 Jun;49(6):755-62. doi: 10.1046/j.1532-5415.2001.49152.x. |
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| ID | Term |
|---|---|
| D007383 | Intermittent Claudication |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
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| Control--Resistance Training |
| Behavioral |
Three times per week for 3 months |
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| 3 months |
| 12042688 | Background | Gardner AW, Katzel LI, Sorkin JD, Goldberg AP. Effects of long-term exercise rehabilitation on claudication distances in patients with peripheral arterial disease: a randomized controlled trial. J Cardiopulm Rehabil. 2002 May-Jun;22(3):192-8. doi: 10.1097/00008483-200205000-00011. |
| 14981444 | Background | Gardner AW, Killewich LA, Montgomery PS, Katzel LI. Response to exercise rehabilitation in smoking and nonsmoking patients with intermittent claudication. J Vasc Surg. 2004 Mar;39(3):531-8. doi: 10.1016/j.jvs.2003.08.037. |
| 16242558 | Background | Gardner AW, Montgomery PS, Flinn WR, Katzel LI. The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. J Vasc Surg. 2005 Oct;42(4):702-9. doi: 10.1016/j.jvs.2005.05.049. |
| 37929770 | Derived | Gardner AW, Montgomery PS, Wang M, Liang M. Effects of Long-Term Home Exercise in Participants With Peripheral Artery Disease. J Am Heart Assoc. 2023 Nov 7;12(21):e029755. doi: 10.1161/JAHA.122.029755. Epub 2023 Nov 6. |
| 30922751 | Derived | Gardner AW, Parker DE, Montgomery PS. Changes in vascular and inflammatory biomarkers after exercise rehabilitation in patients with symptomatic peripheral artery disease. J Vasc Surg. 2019 Oct;70(4):1280-1290. doi: 10.1016/j.jvs.2018.12.056. Epub 2019 Mar 25. |
| 28116164 | Derived | Gardner AW, Parker DE, Montgomery PS. Predictors of Improved Walking after a Supervised Walking Exercise Program in Men and Women with Peripheral Artery Disease. Int J Vasc Med. 2016;2016:2191350. doi: 10.1155/2016/2191350. Epub 2016 Dec 25. |
| 26240075 | Derived | Gardner AW, Parker DE, Montgomery PS. Sex-specific predictors of improved walking with step-monitored, home-based exercise in peripheral artery disease. Vasc Med. 2015 Oct;20(5):424-31. doi: 10.1177/1358863X15596237. Epub 2015 Aug 3. |
| 25237048 | Derived | 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. |
| 24102029 | Derived | Gardner AW, Alaupovic P, Parker DE, Montgomery PS, Esponda OL, Casanegra AI. Influence of peripheral artery disease and statin therapy on apolipoprotein profiles. Int J Vasc Med. 2013;2013:548764. doi: 10.1155/2013/548764. Epub 2013 Sep 11. |
| 21262997 | Derived | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |