Effects of Exercise on Endothelial Function in Stroke Patients - Full Text View

Sponsored by:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00604877

Purpose

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.

Condition	Intervention
Stroke Cerebrovascular Disorders	Behavioral: Treadmill Exercise Behavioral: Stretching/ROM

MedlinePlus related topics: Exercise and Physical Fitness

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Effects of Exercise on Endothelial Function in Stroke Patients

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

Resting and Post-Stressor Fibrinolysis [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Cerebral and lower extremity vasomotor reactivity [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Nitric oxide biomarkers [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Fasting insulin, HOMA-IR, post-load insulin response, glucose tolerance, insulin sensitivity, insulin signaling [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Peak aerobic capacity [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Mobility Function (Timed walks etc..) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Enrollment:	140
Study Start Date:	August 2003
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Behavioral: Treadmill Exercise 3 times per week for 6 months, with target of 45 minutes at 60-70% heart rate range
2: Active Comparator	Behavioral: 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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ischemic Stroke greater than 6 months prior in men or women ages 40-85
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:

Already performing greater than 20 minutes aerobic exercise 3 times per week
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604877

Locations

United States, Maryland
Baltimore VA Medical Center/ University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Frederick M. Ivey, PhD

University of Maryland School of Medicine

More Information

Publications:

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. 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. 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. Review.

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. Epub 2004 Aug 24.

Responsible Party:	University of Maryland School of Medicine ( Frederick M. Ivey, PhD, Assistant Professor )
Study ID Numbers:	AG0092, 5K01AG019242
Study First Received:	January 17, 2008
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00604877
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

exercise
glucose metabolism
insulin sensitivity
Vascular Function

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Ischemia

Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders
Insulin

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009