Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Stroke, a leading cause of disability in the aging population, increases the risk for diabetes, subsequent stroke recurrence, and cardiovascular disease complications. The downsizing of private and federal health care resources, along with the anticipated increase in stroke rates as our population ages, mandate that alternative strategies be developed to reduce the public health burden of stroke. This pilot study may facilitate our knowledge of the timing of paretic leg muscle atrophy, fiber type shift, and the progression of worsening of glucose tolerance after stroke. Knowledge of the skeletal muscle changes occurring in the sub-acute stroke period is essential to create new guidelines incorporating exercise rehabilitation, much like cardiac rehabilitation, in order to facilitate and improve the health care of veteran stroke survivors.

Condition or disease	Intervention/treatment
Stroke	Other: No intervention

Detailed Description:

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:

Other: No intervention
longitudinal follow-up after stroke

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change in body composition [ Time Frame: change in muscle mass from baseline to 3 months ]
   Muscle mass

Secondary Outcome Measures :

1. Change in glucose [ Time Frame: change in glucose from baseline to 3 months ]
   glucose levels
2. Change in physical function [ Time Frame: change in walk distance from baseline to 3 months ]
   walk distance

Biospecimen Retention:   Samples Without DNA

Blood samples will be analyzed for metabolic biomarkers. Muscle tissue is collected for measurements of muscle phenotype. A urine pregnancy test is performed in women of child bearing age before CT imaging to exclude pregnant women due to the risk to an unborn fetus.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Acute Stroke

Criteria

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

• Muscle biopsy Exclusion Criteria:

  • anti-coagulation therapy with heparin, warfarin, or lovenox (anti-platelet therapy is permitted)
  • bleeding disorder
  • allergy to lidocaine

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Baltimore VA Medical Center

Investigators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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