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Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01302197
Enrollment
100
Registered
2011-02-24
Start date
2011-04-13
Completion date
2026-06-30
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Body Composition, Glucose Tolerance

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.

Interventions

OTHERNo intervention

longitudinal follow-up after stroke

Sponsors

Baltimore VA Medical Center
Lead SponsorFED

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in body compositionchange in muscle mass from baseline to 3 monthsMuscle mass

Secondary

MeasureTime frameDescription
Change in glucosechange in glucose from baseline to 3 monthsglucose levels
Change in physical functionchange in walk distance from baseline to 3 monthswalk distance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026