Stroke Clinical Trial
Official title:
Effects of Exercise on Endothelial Function in Stroke Patients
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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