Effects of Exercise on Endothelial Function in Stroke Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Institute on Aging (NIA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00604877
First received: January 17, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Exercise on Endothelial Function in Stroke Patients

Resource links provided by NLM:


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
Experimental: 1 Behavioral: Treadmill Exercise
3 times per week for 6 months, with target of 45 minutes at 60-70% heart rate range
Active Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Frederick M. Ivey, PhD University of Maryland
  More Information

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

Keywords provided by National Institute on Aging (NIA):
exercise
glucose metabolism
insulin sensitivity
Vascular Function

Additional relevant MeSH terms:
Cerebrovascular Disorders
Stroke
Cerebral Infarction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 27, 2014