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Effects of Exercise on Endothelial Function in Stroke Patients

Primary Purpose

Stroke, Cerebrovascular Disorders

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Treadmill Exercise

Stretching/ROM

About this trial

This is an interventional treatment trial for Stroke focused on measuring exercise, glucose metabolism, insulin sensitivity, Vascular Function

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Baltimore VA Medical Center/ University of Maryland School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Resting and Post-Stressor Fibrinolysis

Cerebral and lower extremity vasomotor reactivity

Nitric oxide biomarkers

Fasting insulin, HOMA-IR, post-load insulin response, glucose tolerance, insulin sensitivity, insulin signaling

Secondary Outcome Measures

Peak aerobic capacity

Mobility Function (Timed walks etc..)

Full Information

NCT ID

NCT00604877

First Posted

January 17, 2008

Last Updated

January 17, 2008

Sponsor

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT00604877

Brief Title

Effects of Exercise on Endothelial Function in Stroke Patients

Official Title

Effects of Exercise on Endothelial Function in Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Unknown status

Study Start Date

August 2003 (undefined)

Primary Completion Date

May 2008 (Anticipated)

Study Completion Date

May 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Cerebrovascular Disorders

Keywords

exercise, glucose metabolism, insulin sensitivity, Vascular Function

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Treadmill Exercise

Intervention Description

3 times per week for 6 months, with target of 45 minutes at 60-70% heart rate range

Intervention Type

Behavioral

Intervention Name(s)

Stretching/ROM

Intervention Description

3 times per week for 6 months, passive and active stretching and range of motion (ROM) exercises for the upper and lower extremities

Primary Outcome Measure Information:

Title

Resting and Post-Stressor Fibrinolysis

Time Frame

Baseline and 6 months

Title

Cerebral and lower extremity vasomotor reactivity

Time Frame

Baseline and 6 months

Title

Nitric oxide biomarkers

Time Frame

Baseline and 6 months

Title

Fasting insulin, HOMA-IR, post-load insulin response, glucose tolerance, insulin sensitivity, insulin signaling

Time Frame

Baseline and 6 months

Secondary Outcome Measure Information:

Title

Peak aerobic capacity

Time Frame

Baseline and 6 months

Title

Mobility Function (Timed walks etc..)

Time Frame

Baseline and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederick M. Ivey, PhD

Organizational Affiliation

University of Maryland, Baltimore

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baltimore VA Medical Center/ University of Maryland School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17702957

Citation

Ivey FM, Ryan AS, Hafer-Macko CE, Goldberg AP, Macko RF. Treadmill aerobic training improves glucose tolerance and indices of insulin sensitivity in disabled stroke survivors: a preliminary report. Stroke. 2007 Oct;38(10):2752-8. doi: 10.1161/STROKEAHA.107.490391. Epub 2007 Aug 16.

Results Reference

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PubMed Identifier

16888377

Citation

Ivey FM, Ryan AS, Hafer-Macko CE, Garrity BM, Sorkin JD, Goldberg AP, Macko RF. High prevalence of abnormal glucose metabolism and poor sensitivity of fasting plasma glucose in the chronic phase of stroke. Cerebrovasc Dis. 2006;22(5-6):368-71. doi: 10.1159/000094853. Epub 2006 Aug 3.

Results Reference

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PubMed Identifier

15735997

Citation

Ivey FM, Macko RF, Ryan AS, Hafer-Macko CE. Cardiovascular health and fitness after stroke. Top Stroke Rehabil. 2005 Winter;12(1):1-16. doi: 10.1310/GEEU-YRUY-VJ72-LEAR.

Results Reference

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PubMed Identifier

15331874

Citation

Ivey FM, Gardner AW, Dobrovolny CL, Macko RF. Unilateral impairment of leg blood flow in chronic stroke patients. Cerebrovasc Dis. 2004;18(4):283-9. doi: 10.1159/000080353. Epub 2004 Aug 24.

Results Reference

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Effects of Exercise on Endothelial Function in Stroke Patients

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