Effects of Exercise on Endothelial Function in Stroke Patients

NCT00604877 | Unknown DMC

• 2 other identifiers: AG00925K01AG019242
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebrovascular Disorders

Keywords

exercise; glucose metabolism; insulin sensitivity; Vascular Function

Outcome Measures

Primary Outcomes (4)

• Resting and Post-Stressor Fibrinolysis

  Baseline and 6 months

• Cerebral and lower extremity vasomotor reactivity

  Baseline and 6 months

• Nitric oxide biomarkers

  Baseline and 6 months

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

  Baseline and 6 months

Secondary Outcomes (2)

• Peak aerobic capacity

  Baseline and 6 months

• Mobility Function (Timed walks etc..)

  Baseline and 6 months

Study Arms (2)

1

EXPERIMENTAL

Behavioral: Treadmill Exercise

2

ACTIVE COMPARATOR

Behavioral: Stretching/ROM

Interventions

Treadmill Exercise BEHAVIORAL

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

1

Stretching/ROM BEHAVIORAL

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

2

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

Baltimore VA Medical Center/ University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Related Publications (4)

• 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.

  PMID: 17702957 BACKGROUND

• 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.

  PMID: 16888377 BACKGROUND

• 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.

  PMID: 15735997 BACKGROUND

• 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.

  PMID: 15331874 BACKGROUND

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders; Motor Activity; Insulin Resistance

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Frederick M. Ivey, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 30, 2008
• Study Start: August 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: January 30, 2008

Record last verified: 2008-01

Locations

US (1)