Effect of Sarcopenia in Stroke Patients

NCT05671705 | Completed

• 1 other identifier: VC22ONDI0185
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Stroke; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Hand grip strength

  within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke

• quadriceps muscle strength

  within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke

• Fugl-Meyer motor scale

  within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke

• Functional Ambulation Category

  within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke

• Berg balance scale

  within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke

Study Arms (2)

Stroke patients with sarcopenia

Group will be stratified according to gender

Diagnostic Test: DEXA Scan

Stroke patients without sarcopenia

Group will be stratified according to gender

Diagnostic Test: DEXA Scan

Interventions

DEXA Scan DIAGNOSTIC_TEST

Fu of diagnostic tests

Also known as: Serum biomarkers, SEMG signals and MRI changes

Stroke patients with sarcopenia; Stroke patients without sarcopenia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead
• Saint Vincent's Hospital, Korea: collaborator

Study Sites (2)

The Catholic University of Korea

Bucheon-si, Gyeonggi-do, 14647, South Korea

Location

St. Vincent's Hospital

Suwon, 16247, South Korea

Location

MeSH Terms

Conditions

Stroke; Sarcopenia

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., PhD.

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: January 5, 2023
• Study Start: January 2, 2023
• Primary Completion: December 27, 2024
• Study Completion: December 27, 2024
• Last Updated: June 11, 2025

Record last verified: 2025-01

Locations

KR (2)