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Active, Not Recruiting

NCT Number: NCT01302197

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kernan Hospital, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

longitudinal follow-up after stroke

Primary outcomes

  1. Change in body composition

    Time frame: change in muscle mass from baseline to 3 months

    Muscle mass

Secondary outcomes

  1. Change in glucose

    Time frame: change in glucose from baseline to 3 months

    glucose levels

  2. Change in physical function

    Time frame: change in walk distance from baseline to 3 months

    walk distance

Sponsors and collaborators

Lead sponsor

Baltimore VA Medical Center

Fed

Registry information

Important dates

Study start
2011
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2011
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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