Effect of Sarcopenia in Stroke Patients

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: Completed
• Conditions: Stroke; Sarcopenia
• Intervention / Treatment: Diagnostic test: DEXA Scan

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: Observational
• Enrollment (Actual): 83

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change of Modified Rankin Scale	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

Outcome Measure	Measure Description	Time Frame
Hand grip strength	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	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	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	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	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	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	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	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	BNDF, IL-6	within 4 weeks from the first onset of the stroke
Digitalized SEMG signals	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

• Sponsor: The Catholic University of Korea
• Collaborators: Saint Vincent's Hospital, Korea

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Actual): December 27, 2024
• Study Completion (Actual): December 27, 2024

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Stroke; Sarcopenia
• Other Study ID 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