Effects of Exercise on Endothelial Function in Stroke Patients

January 17, 2008 updated by: National Institute on Aging (NIA)
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak aerobic capacity
Time Frame: Baseline and 6 months
Baseline and 6 months
Mobility Function (Timed walks etc..)
Time Frame: Baseline and 6 months
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Frederick M. Ivey, PhD, University of Maryland School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Anticipated)

May 1, 2008

Study Completion (Anticipated)

May 1, 2008

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 17, 2008

First Posted (Estimate)

January 30, 2008

Study Record Updates

Last Update Posted (Estimate)

January 30, 2008

Last Update Submitted That Met QC Criteria

January 17, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0092
  • 5K01AG019242 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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