Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke - Full Text View

Purpose

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	Intervention
Stroke	Other: No intervention


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

Further study details as provided by Baltimore VA Medical Center:

Primary Outcome Measures:

Change in body composition [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
Muscle and fat mass, muscle and fat volume, muscle attenuation, bone density
Change in Oral Glucose Tolerance [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
glucose and insulin levels by oral glucose tolerance test
Change in Muscle phenotype [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
myosin heavy chain, capillarization, inflammation
Change in physical function [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
walk tests,dynamic gait and balance, strength, activity levels

Secondary Outcome Measures:

Change in biomarkers [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
Inflammation, pro-thrombosis, hormones
Change in scores of questionnaires [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
scales of mobility, cognitive function, self-efficacy

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.


Estimated Enrollment:	100
Study Start Date:	September 2011
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Acute Stroke Recovery	Other: No intervention longitudinal follow-up after stroke

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.

Eligibility


Ages Eligible for Study:	21 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302197

Contacts


Contact: Alice Ryan, Ph.D.	410-605-7851	aryan@grecc.umaryland.edu

Locations


United States, Maryland
University of Maryland Medical System	Recruiting
Baltimore, Maryland, United States, 21201
VA Maryland Health Care System, Baltimore	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Beth DiSanzo Beth.Disanzo@va.gov
Kernan Hospital	Recruiting
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


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
Study First Received:	February 23, 2011
Last Updated:	July 21, 2015
Health Authority:	United States: Federal Government

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2016