ClinicalTrials.gg
Status unknownNCT01302197Updated Aug 6, 2024

Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

An observational study in Stroke, sponsored by Baltimore VA Medical Center. Status unknown at 3 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Baltimore VA Medical Center · Observational

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
21 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Stroke

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Keywords

  • Stroke
  • Body Composition
  • Glucose Tolerance
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In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's planned enrollment of 100 is below the median of 160 across 1,729 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Baltimore VA Medical Center is the lead sponsor of 19 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Acute Stroke

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Biospecimen retention
Samples without dna

Interventions

  • OtherNo intervention

    longitudinal follow-up after stroke

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What researchers measure

Primary outcomes

  1. Change in body composition

    Muscle mass

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

Secondary outcomes

  1. Change in glucose

    glucose levels

    Time frame: change in glucose from baseline to 3 months

  2. Change in physical function

    walk distance

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

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Study locations

3 sites
  • University of Maryland Medical System
    Baltimore, Maryland 21201, United States
  • VA Maryland Health Care System, Baltimore
    Baltimore, Maryland 21201, United States
  • Kernan Hospital
    Baltimore, Maryland 21207, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01302197
Lead sponsor
Baltimore VA Medical Center
Responsible party
Alice S. Ryan, PhD (Professor of Medicine, Baltimore VA Medical Center) — Principal investigator
First posted
Feb 24, 2011
Start date
Apr 13, 2011
Primary completion
Dec 2025 (estimated)
Completion
Jun 2026 (estimated)
Last update
Aug 6, 2024

Study contacts

Alice S Ryan, Ph.D.
principal investigator · University of Maryland School of Medicine, Baltimore VA Research Service

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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