StrokeNCT01302197
Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke
An observational study of Stroke, run by Baltimore VA Medical Center at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Apr 2011to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute Stroke
Who may be able to join
- 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
Who cannot join
- 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:
Show all 9Show fewer
- anti-coagulation therapy with heparin, warfarin, or lovenox (anti-platelet therapy is permitted)
- bleeding disorder
- allergy to lidocaine
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland Medical System
Baltimore, Maryland, 21201
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201
Kernan Hospital
Baltimore, Maryland, 21207
About this study
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.
- Conditions
- Stroke
- Being tested
- No intervention
- Keywords
- Stroke, Body Composition, Glucose Tolerance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
longitudinal follow-up after stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition
Muscle mass
Measured: change in muscle mass from baseline to 3 months
Secondary outcomes (2)
Change in glucose
glucose levels
Measured: change in glucose from baseline to 3 months
Change in physical function
walk distance
Measured: change in walk distance from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study start13 Apr 2011
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Alice S. Ryan, PhD, Baltimore VA Medical Center
- Investigators
- Alice S Ryan, Ph.D., Principal investigator, University of Maryland School of Medicine, Baltimore VA Research Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302197
- Sponsor's protocol ID
- HP-00042905
- Status last verified
- Aug 2024
- First submitted
- 23 Feb 2011
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke
- ClinicalTrials.gov ID
- NCT01302197
- Acronym / sponsor ID
- HP-00042905
- Conditions
- Stroke
- Keywords
- Stroke, Body Composition, Glucose Tolerance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Study start
- 13 Apr 2011 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Stroke
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionlongitudinal follow-up after stroke | Other | – |
Primary outcome
Change in body composition
Time frame: change in muscle mass from baseline to 3 months
Muscle mass
2 secondary outcomes
Change in glucose
Time frame: change in glucose from baseline to 3 months
Change in physical function
Time frame: change in walk distance from baseline to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
The AHA Oneida Study
Oneida Nation Members
Active, not recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Active, not recruiting
Brain Connectivity Analysis
Neural Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice S Ryan, Ph.D. principal investigator
University of Maryland School of Medicine, Baltimore VA Research Service
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Baltimore VA Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition (time frame: change in muscle mass from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.