Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

Sponsor
Baltimore VA Medical Center (U.S. Fed)
Overall Status
Active, not recruiting
CT.gov ID
NCT01302197
Collaborator
(none)
100
3
133.6
33.3
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke
Actual Study Start Date :
Apr 13, 2011
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Jun 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Change in body composition [change in muscle mass from baseline to 3 months]

    Muscle mass

Secondary Outcome Measures

  1. Change in glucose [change in glucose from baseline to 3 months]

    glucose levels

  2. Change in physical function [change in walk distance from baseline to 3 months]

    walk distance

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Maryland Medical System Baltimore Maryland United States 21201
2 VA Maryland Health Care System, Baltimore Baltimore Maryland United States 21201
3 Kernan Hospital Baltimore Maryland United States 21207

Sponsors and Collaborators

  • Baltimore VA Medical Center

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alice S. Ryan, PhD, Professor of Medicine, Baltimore VA Medical Center
ClinicalTrials.gov Identifier:
NCT01302197
Other Study ID Numbers:
  • HP-00042905
First Posted:
Feb 24, 2011
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Alice S. Ryan, PhD, Professor of Medicine, Baltimore VA Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2021