Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

NCT01302197 | Active Not Recruiting DMC

• 1 other identifier: HP-00042905
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

Stroke; Body Composition; Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

• Change in body composition

  Muscle mass

  change in muscle mass from baseline to 3 months

Secondary Outcomes (2)

• Change in glucose

  change in glucose from baseline to 3 months

• Change in physical function

  change in walk distance from baseline to 3 months

Interventions

No intervention OTHER

longitudinal follow-up after stroke

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute Stroke

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baltimore VA Medical Center: lead

Study Sites (3)

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

Kernan Hospital

Baltimore, Maryland, 21207, United States

Location

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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alice S Ryan, Ph.D.

  University of Maryland School of Medicine, Baltimore VA Research Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: April 13, 2011
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)