Overview

This trial is active, not recruiting.

Conditions stroke, cerebrovascular disorders
Treatments treadmill exercise, stretching/rom
Sponsor National Institute on Aging (NIA)
Start date August 2003
End date May 2008
Trial size 140 participants
Trial identifier NCT00604877, 5K01AG019242, AG0092

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
treadmill exercise
3 times per week for 6 months, with target of 45 minutes at 60-70% heart rate range
(Active Comparator)
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

Primary Outcomes

Measure
Resting and Post-Stressor Fibrinolysis
time frame: Baseline and 6 months
Cerebral and lower extremity vasomotor reactivity
time frame: Baseline and 6 months
Nitric oxide biomarkers
time frame: Baseline and 6 months
Fasting insulin, HOMA-IR, post-load insulin response, glucose tolerance, insulin sensitivity, insulin signaling
time frame: Baseline and 6 months

Secondary Outcomes

Measure
Peak aerobic capacity
time frame: Baseline and 6 months
Mobility Function (Timed walks etc..)
time frame: Baseline and 6 months

Eligibility Criteria

Male or female participants from 40 years up to 85 years old.

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

Additional Information

Official title Effects of Exercise on Endothelial Function in Stroke Patients
Principal investigator Frederick M. Ivey, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by National Institute on Aging (NIA).