Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke
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ClinicalTrials.gov Identifier: NCT01302197 |
Recruitment Status
:
Active, not recruiting
First Posted
: February 24, 2011
Last Update Posted
: February 13, 2018
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Condition or disease | Intervention/treatment |
---|---|
Stroke | Other: No intervention |
The vast majority of cerebrovascular accidents are reported in persons older than 55 years of age and occur in over 780,000 persons each year in the U.S. As our adult population ages, the number of strokes in the United States is anticipated to double, reaching nearly 1.5 million annually by the year 2050. Following stroke, patients remain at continued high risk for recurrent stroke with almost a third of them suffering recurrent stroke within 5 years, even despite optimal medical management. Age and cardiac disease are among the most important longitudinal predictors of cardiovascular health outcomes and survival after stroke. Notably, 75% of chronic stroke survivors have residual disability emphasizing the need for rehabilitation strategies.
Knowledge of the skeletal muscle changes that occur in the early phases after stroke is essential to create new guidelines which incorporate exercise rehabilitation, much like cardiac rehabilitation, in order to facilitate and improve the health care of stroke survivors.
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | October 2017 |
Estimated Study Completion Date : | December 2018 |
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Other: No intervention
- Change in body composition [ Time Frame: change in muscle mass from baseline to 3 months ]Muscle mass
- Change in glucose [ Time Frame: change in glucose from baseline to 3 months ]glucose levels
- Change in physical function [ Time Frame: change in walk distance from baseline to 3 months ]walk distance
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Men or women 21 years of age or older
- BMI between 20-50 kg/m2
- Presenting within a month after stroke onset with residual hemiparetic deficit
- Patients must have adequate language and neurocognitive function to participate in testing and give adequate informed consent
Exclusion Criteria:
- Patients deemed too disabled to participate in physical therapy, or patients with minimal deficits, or patients who fully recovered after their stroke, in which physical therapy is not necessary
- Unstable angina, CHF, severe PAD
- Dementia or untreated major depression
- Severe receptive or global aphasia
- Heavy alcohol use defined by greater than 3 oz. liquor, 12 oz of wine or 32 oz of beer daily
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Muscle biopsy Exclusion Criteria:
- anti-coagulation therapy with heparin, warfarin, or lovenox (anti-platelet therapy is permitted)
- bleeding disorder
- allergy to lidocaine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302197
United States, Maryland | |
University of Maryland Medical System | |
Baltimore, Maryland, United States, 21201 | |
VA Maryland Health Care System, Baltimore | |
Baltimore, Maryland, United States, 21201 | |
Kernan Hospital | |
Baltimore, Maryland, United States, 21207 |
Principal Investigator: | Alice S Ryan, Ph.D. | University of Maryland School of Medicine, Baltimore VA Research Service | |
Principal Investigator: | Charlene Hafer-Macko, M.D. | University of Maryland, VA Research Service, Department of Neurology |
Responsible Party: | Alice S. Ryan, PhD, Professor of Medicine, Baltimore VA Medical Center |
ClinicalTrials.gov Identifier: | NCT01302197 History of Changes |
Other Study ID Numbers: |
HP-00042905 |
First Posted: | February 24, 2011 Key Record Dates |
Last Update Posted: | February 13, 2018 |
Last Verified: | February 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Alice S. Ryan, PhD, Baltimore VA Medical Center:
Stroke Body Composition Glucose Tolerance |
Additional relevant MeSH terms:
Stroke Atrophy Muscular Atrophy Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical Neuromuscular Manifestations Neurologic Manifestations Signs and Symptoms |