Effects of Exercise on Endothelial Function in Stroke Patients

Active, not recruiting

Phase N/A Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Treadmill Exercise Behavioral
    Intervention Desc: 3 times per week for 6 months, with target of 45 minutes at 60-70% heart rate range
    ARM 1: Kind: Experimental
    Label: 1
  • Stretching/ROM Behavioral
    Intervention Desc: 3 times per week for 6 months, passive and active stretching and range of motion (ROM) exercises for the upper and lower extremities
    ARM 1: Kind: Experimental
    Label: 2

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Resting and Post-Stressor Fibrinolysis Baseline and 6 months No
Primary Cerebral and lower extremity vasomotor reactivity Baseline and 6 months No
Primary Nitric oxide biomarkers Baseline and 6 months No
Primary Fasting insulin, HOMA-IR, post-load insulin response, glucose tolerance, insulin sensitivity, insulin signaling Baseline and 6 months No
Secondary Peak aerobic capacity Baseline and 6 months No
Secondary Mobility Function (Timed walks etc..) Baseline and 6 months No

Sponsors