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

February 23, 2011
September 5, 2014
September 2011
June 2016   (final data collection date for primary outcome measure)
  • 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
  • Change in body composition [ Time Frame: baseline, 2 month, 4 month, 6 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, 2 month, 4 month, 6 month ] [ Designated as safety issue: No ]
    glucose and insulin levels by oral glucose tolerance test
  • Change in Muscle phenotype [ Time Frame: baseline, 2 month, 4 month, 6 month ] [ Designated as safety issue: No ]
    myosin heavy chain, capillarization, inflammation
  • Change in physical function [ Time Frame: baseline, 2 month, 4 month, 6 month ] [ Designated as safety issue: No ]
    walk tests,dynamic gait and balance, strength, activity levels
Complete list of historical versions of study NCT01302197 on ClinicalTrials.gov Archive Site
  • 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
  • Change in biomarkers [ Time Frame: baseline, 2 month, 4 month, 6 month ] [ Designated as safety issue: No ]
    Inflammation, pro-thrombosis, hormones
  • Change in scores of questionnaires [ Time Frame: baseline, 2 month, 4 month, 6 month ] [ Designated as safety issue: No ]
    scales of mobility, cognitive function, self-efficacy
Not Provided
Not Provided
 
Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.

Non-Probability Sample

Acute Stroke

Stroke
Other: No intervention
longitudinal follow-up after stroke
Acute Stroke Recovery
Intervention: Other: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Alice Ryan, Ph.D. 410-605-7851 aryan@grecc.umaryland.edu
United States
 
NCT01302197
HP-00042905
Yes
Alice S. Ryan, PhD, Baltimore VA Medical Center
Baltimore VA Medical Center
Not Provided
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
Baltimore VA Medical Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP