Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

NCT ID: NCT01302197

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-13
• Study Completion Date: 2026-06-30

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.

Conditions

Stroke

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention

longitudinal follow-up after stroke

Intervention Type: OTHER

Eligibility 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

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baltimore VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Alice S. Ryan, PhD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alice S Ryan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland School of Medicine, Baltimore VA Research Service

Locations

University of Maryland Medical System

Baltimore, Maryland, United States

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, United States

Kernan Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00042905

Identifier Type: -

Identifier Source: org_study_id