Effects of Exercise on Endothelial Function in Stroke Patients
NCT ID: NCT00604877
Last Updated: 2008-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2003-08-31
2008-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Treadmill Exercise
3 times per week for 6 months, with target of 45 minutes at 60-70% heart rate range
2
Stretching/ROM
3 times per week for 6 months, passive and active stretching and range of motion (ROM) exercises for the upper and lower extremities
Interventions
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Treadmill Exercise
3 times per week for 6 months, with target of 45 minutes at 60-70% heart rate range
Stretching/ROM
3 times per week for 6 months, passive and active stretching and range of motion (ROM) exercises for the upper and lower extremities
Eligibility Criteria
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Inclusion Criteria
* Residual hemiparetic gait deficits
* Already completed all conventional inpatient and outpatient physical therapy
* Adequate language and neurocognitive function to participate in exercise testing and training
Exclusion Criteria
* All insulin dependent diabetics; non-insulin dependent diabetics with fasting glucose greater than 180 mg/dl
* Alcohol consumption greater than 2oz. liquor or equivalent per day
* Cardiac history of: (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, (c) symptomatic congestive heart failure, (d) hemodynamically significant valvular dysfunction
* Medical History of: (a) recent (less than 3 months) hospitalization for severe medical disease, (b) PAOD (Peripheral Arterial Obstructive Disease) with claudication, (c) orthopedic or chronic pain condition restricting exercise, (d) pulmonary or renal failure, (e) active cancer, (f) poorly controlled hypertension (greater than 160/100) (g) Anemia defined by hematocrit less than 30
* Neurological History of: (a) dementia with Mini-Mental Status Score less than 23 (less than 17 if education level at or below 8th grade), and diagnostic confirmation by neurologist or geropsychiatrist, (b) severe receptive or global aphasia which confounds testing and training, operationally defined as unable to follow 2 point commands, (c) hemiparetic gait from prior stroke preceding the index stroke defining eligibility, (d) non-stroke neurological disorder restricting exercise (e.g. Parkinson's Syndrome), (e) untreated major depression
* Pregnancy
40 Years
85 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Responsible Party
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University of Maryland School of Medicine
Principal Investigators
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Frederick M. Ivey, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Locations
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Baltimore VA Medical Center/ University of Maryland School of Medicine
Baltimore, Maryland, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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AG0092
Identifier Type: -
Identifier Source: org_study_id