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Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Baltimore VA Medical Center
Sponsor:
Information provided by (Responsible Party):
Alice S. Ryan, PhD, Baltimore VA Medical Center
ClinicalTrials.gov Identifier:
NCT01302197
First received: February 23, 2011
Last updated: September 5, 2014
Last verified: September 2014
History of Changes
  Purpose

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 Intervention
Stroke
 Other: No intervention

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

Further study details as provided by Baltimore VA Medical Center:

Primary Outcome Measures:
  • Change in body composition [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
    Muscle and fat mass, muscle and fat volume, muscle attenuation, bone density

  • Change in Oral Glucose Tolerance [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
    glucose and insulin levels by oral glucose tolerance test

  • Change in Muscle phenotype [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
    myosin heavy chain, capillarization, inflammation

  • Change in physical function [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
    walk tests,dynamic gait and balance, strength, activity levels


Secondary Outcome Measures:
  • Change in biomarkers [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
    Inflammation, pro-thrombosis, hormones

  • Change in scores of questionnaires [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
    scales of mobility, cognitive function, self-efficacy


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.
Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acute Stroke Recovery Other: No intervention
longitudinal follow-up after stroke

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.

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute Stroke

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302197

Contacts
Contact: Alice Ryan, Ph.D. 410-605-7851 aryan@grecc.umaryland.edu

Locations
United States, Maryland
Kernan Hospital Recruiting
Baltimore, Maryland, United States, 21207
University of Maryland Medical System Recruiting
Baltimore, Maryland, United States, 21201
VA Maryland Health Care System, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Beth DiSanzo       Beth.Disanzo@va.gov   
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
  More Information

No publications provided

Responsible Party: Alice S. Ryan, PhD, Professor of Medicine, Baltimore VA Medical Center
ClinicalTrials.gov Identifier: NCT01302197     History of Changes
Other Study ID Numbers: HP-00042905
Study First Received: February 23, 2011
Last Updated: September 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Baltimore VA Medical Center:
Stroke
Body Composition
Glucose Tolerance

ClinicalTrials.gov processed this record on March 03, 2015