Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

Stroke Clinical Trial

Official title:

Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01302197
• Other study ID #: HP-00042905
• Status: Active, not recruiting
• Start date: April 13, 2011
• Est. completion date: June 2024

Study information

• Verified date: February 2023
• Source: Baltimore VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Muscular Atrophy
• Stroke

Intervention

Other:
• No intervention
longitudinal follow-up after stroke

Locations

Country	Name	City	State
United States	Kernan Hospital	Baltimore	Maryland
United States	University of Maryland Medical System	Baltimore	Maryland
United States	VA Maryland Health Care System, Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Baltimore VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body composition	Muscle mass	change in muscle mass from baseline to 3 months
Secondary	Change in glucose	glucose levels	change in glucose from baseline to 3 months
Secondary	Change in physical function	walk distance	change in walk distance from baseline to 3 months