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 Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • VA Maryland Health Care System, Baltimore
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical System
    • Baltimore, Maryland, United States, 21207
      • Kernan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute Stroke

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body composition	Muscle mass	change in muscle mass from baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glucose	glucose levels	change in glucose from baseline to 3 months
Change in physical function	walk distance	change in walk distance from baseline to 3 months

Collaborators and Investigators

• Sponsor: Baltimore VA Medical Center
• Investigators: Principal Investigator: Alice S Ryan, Ph.D., University of Maryland School of Medicine, Baltimore VA Research Service

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 13, 2011
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): June 1, 2024

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (ESTIMATE): February 24, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Body Composition; Glucose Tolerance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Stroke; Muscular Atrophy; Atrophy
• Other Study ID Numbers: HP-00042905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO