Effect of Sarcopenia in Stroke Patients

June 8, 2025 updated by: Sun Im, The Catholic University of Korea

Primary research purpose:

-Prospective study to screen post stroke patients with sarcopenia and evaluate its effect on recovery

Secondary research purpose:

  • To determine the degree of sarcopenia and correlation with poor functional prognosis of stroke in the stroke patient group.
  • To determine the degree of sarcopenia and correlation with dixon MRI of thigh muscle
  • To evaluate surface EMG (SEMG)-based signals and correlation with sarcopenia
  • To determine the degree of sarcopenia and correlation with brain morphometric changes

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with first-ever stroke will be enrolled and assessed for sarcopenia. The evaluation parameters will include standard sarcopenia parameters and also SEMG-based signals and imaging studies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
        • The Catholic University of Korea
      • Suwon-si, Korea, Republic of, 16247
        • St. Vincent's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Recruited subjects will be allocated into 4 different groups according to presence of sarcopenia according to the Asian Working Group for Sarcopenia (2019) criteria.

  • Post stroke male patients with sarcopenia
  • Post stroke female patients with sarcopenia
  • Post stroke male patients without sarcopenia
  • Post stroke female patients without sarcopenia

Description

Inclusion Criteria:

  • Patients 65 years of age or older, stroke patients with first onset within 4 weeks

Exclusion Criteria:

  • Patients who have not been evaluated for sarcopenia
  • Patients with neuromuscular diseases other than stroke that may affect gait function
  • Patients unable to conduct clinical trials according to instructions
  • Patients with uncontrolled medical/surgical disease
  • Patients with metal substances in the body such as cardiac pacemakers, cochlear implants, etc.
  • Patients who have difficulty collecting blood
  • Patients who are difficult to follow up after 6 months of onset due to moving to another area
  • Patients who have Parkinson's disease, dementia, or have a history of neuromuscular diseases such as Guillain-Barré syndrome or myasthenia gravis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Stroke patients with sarcopenia
Group will be stratified according to gender
Diagnostic test: DEXA Scan
Fu of diagnostic tests
Other Names:
  • Serum biomarkers, SEMG signals and MRI changes
Stroke patients without sarcopenia
Group will be stratified according to gender
Diagnostic test: DEXA Scan
Fu of diagnostic tests
Other Names:
  • Serum biomarkers, SEMG signals and MRI changes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Modified Rankin Scale
Time Frame: 6 months from the first onset of the stroke
Functional Disability -> The scale runs from 0-6, running from perfect health without symptoms(0) to death(6).
6 months from the first onset of the stroke

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hand grip strength
Time Frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Grip strength: Grip strength will be measured using a dynamometer
within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
quadriceps muscle strength
Time Frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Lower extremity strength assessment:change in isometric quadriceps muscle strength (kg) from initial evaluation to the final evaluation
within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Fugl-Meyer motor scale
Time Frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Motor function assessment : Fugl-Meyer motor scale from initial evaluation to the final evaluation (Upper Extremity maximum score = 66; Lower Extremity maximum score = 34, Higher score means better outcome)
within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Functional Ambulation Category
Time Frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Gait function assessment : Functional Ambulation Category from initial evaluation to the final evaluation (Minimum 0, Maximum 5; Higher score means better outcome)
within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Berg balance scale
Time Frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Balance function: change in Berg balance scale from initial evaluation to the final evaluation (Minimum score 0, Maximum score 56, Higher score means better outcome)
within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Brain MRI
Time Frame: within 4 weeks and 6 months from the first onset of the stroke
Brain atrophy : change in the Global cortical atrophy scale(0-3) of the cerebral cortex from initial evaluation to the final evaluation
within 4 weeks and 6 months from the first onset of the stroke
Thigh Dixon MRI
Time Frame: within 4 weeks and 6 months from the first onset of the stroke
Muscle quality : muscle circumference measured by the thigh MRI from initial evaluation to the final evaluation
within 4 weeks and 6 months from the first onset of the stroke
Muscle ultrasonography
Time Frame: within 4 weeks and 6 months from the first onset of the stroke
muscle thickness(cm) measured by the ultrasound of the quadriceps muscle from initial evaluation to the final evaluation
within 4 weeks and 6 months from the first onset of the stroke
serum biomarkers for sarcopenia
Time Frame: within 4 weeks from the first onset of the stroke
BNDF, IL-6
within 4 weeks from the first onset of the stroke
Digitalized SEMG signals
Time Frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
state of the art EMG signals will be collected to assess muscle quality changes after stroke
within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Catholic University of Korea

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Saint Vincent's Hospital, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VC22ONDI0185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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