Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke|
- 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
- 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.
|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)|
|Acute Stroke Recovery||
Other: No intervention
longitudinal follow-up after stroke
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302197
|Contact: Alice Ryan, Ph.D.||firstname.lastname@example.org|
|United States, Maryland|
|Baltimore, Maryland, United States, 21207|
|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|
|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|