Clinical trial NCT01302197: Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke
Official title: Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
Keywords: Stroke
Body Composition
Glucose Tolerance
Lead sponsor: Baltimore VA Medical Center
Sponsor class: FED
First posted: 2011-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Stroke

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.

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 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

Primary outcomes:
measure: Change in body composition
timeFrame: change in muscle mass from baseline to 3 months
Secondary outcomes:
measure: Change in glucose
timeFrame: change in glucose from baseline to 3 months
measure: Change in physical function
timeFrame: change in walk distance from baseline to 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
city: Baltimore
country: United States
facility: VA Maryland Health Care System, Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Kernan Hospital
state: Maryland
Study officials:
affiliation: University of Maryland School of Medicine, Baltimore VA Research Service
name: Alice S Ryan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: