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| ID | Type | Description | Link |
|---|---|---|---|
| 5K01AG019242 | U.S. NIH Grant/Contract | View source |
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This study examines the hypothesis that 6 months of treadmill aerobic exercise training improves fibrinolysis (clot defense mechanism) and vasomotor function in chronic hemiparetic (muscular weakness or partial paralysis restricted to one side of the body) stroke patients compared to a control intervention, and that these changes are associated with reduced plasma insulin levels and improved insulin sensitivity / glucose metabolism in this population.
Stroke is the leading cause of disability and third leading cause of death in the United States. Each year approximately 750,000 individuals suffer a stroke, after which they remain at high risk for recurrent stroke and cardiovascular events. Incidence of stroke nearly doubles with each successive decade in older adults, with about 90% of strokes occurring in individuals over 55 years of age.
Following stroke, physical inactivity in advancing age increases the incidence of elevated insulin levels and the insulin resistance syndrome, which are powerful factors that heighten risk for recurrent stroke and myocardial infarction (MI) by impairing fibrinolysis and vasomotor reactivity. Currently, prevention of recurrent stroke and MI depends on best medical management, including antiplatelet therapy, which has limited efficacy. Though aerobic exercise training (AEX) has been shown to improve insulin-glucose metabolism, fibrinolysis profiles, and vasomotor reactivity in healthy elderly and type 2 diabetics, there are no data on the effects of AEX on insulin sensitivity and related vascular endothelial cell function in the chronic hemiparetic stroke population. This trial addresses a significant public health gap, in that aerobic exercise rehabilitation therapy has never been systematically studied as a means to improve cardiovascular health profiles in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treadmill Exercise | Behavioral | 3 times per week for 6 months, with target of 45 minutes at 60-70% heart rate range |
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| Measure | Description | Time Frame |
|---|---|---|
| Resting and Post-Stressor Fibrinolysis | Baseline and 6 months | |
| Cerebral and lower extremity vasomotor reactivity | Baseline and 6 months | |
| Nitric oxide biomarkers | Baseline and 6 months | |
| Fasting insulin, HOMA-IR, post-load insulin response, glucose tolerance, insulin sensitivity, insulin signaling | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Peak aerobic capacity | Baseline and 6 months | |
| Mobility Function (Timed walks etc..) | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick M. Ivey, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center/ University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17702957 | Background | Ivey FM, Ryan AS, Hafer-Macko CE, Goldberg AP, Macko RF. Treadmill aerobic training improves glucose tolerance and indices of insulin sensitivity in disabled stroke survivors: a preliminary report. Stroke. 2007 Oct;38(10):2752-8. doi: 10.1161/STROKEAHA.107.490391. Epub 2007 Aug 16. | |
| 16888377 | Background | Ivey FM, Ryan AS, Hafer-Macko CE, Garrity BM, Sorkin JD, Goldberg AP, Macko RF. High prevalence of abnormal glucose metabolism and poor sensitivity of fasting plasma glucose in the chronic phase of stroke. Cerebrovasc Dis. 2006;22(5-6):368-71. doi: 10.1159/000094853. Epub 2006 Aug 3. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D009043 | Motor Activity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| Stretching/ROM | Behavioral | 3 times per week for 6 months, passive and active stretching and range of motion (ROM) exercises for the upper and lower extremities |
|
| 15735997 | Background | Ivey FM, Macko RF, Ryan AS, Hafer-Macko CE. Cardiovascular health and fitness after stroke. Top Stroke Rehabil. 2005 Winter;12(1):1-16. doi: 10.1310/GEEU-YRUY-VJ72-LEAR. |
| 15331874 | Background | Ivey FM, Gardner AW, Dobrovolny CL, Macko RF. Unilateral impairment of leg blood flow in chronic stroke patients. Cerebrovasc Dis. 2004;18(4):283-9. doi: 10.1159/000080353. Epub 2004 Aug 24. |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |