Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

Sponsors

Lead sponsor: Baltimore VA Medical Center

Source Baltimore VA Medical Center
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.

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.

Overall Status Active, not recruiting
Start Date April 13, 2011
Completion Date June 2021
Primary Completion Date December 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Change in body composition change in muscle mass from baseline to 3 months
Secondary Outcome
Measure Time Frame
Change in glucose change in glucose from baseline to 3 months
Change in physical function change in walk distance from baseline to 3 months
Enrollment 100
Condition
Intervention

Intervention type: Other

Intervention name: No intervention

Description: longitudinal follow-up after stroke

Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility
University of Maryland Medical System | Baltimore, Maryland, 21201, United States
VA Maryland Health Care System, Baltimore | Baltimore, Maryland, 21201, United States
Kernan Hospital | Baltimore, Maryland, 21207, United States
Location Countries

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Baltimore VA Medical Center

Investigator full name: Alice S. Ryan, PhD

Investigator title: Professor of Medicine

Keywords
Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational model: Other

Time perspective: Prospective

Source: ClinicalTrials.gov