Effect of Sarcopenia in Stroke Patients

Recruiting

• Conditions: Sarcopenia; Stroke
• Interventions: Diagnostic Test: DEXA Scan

• Registration Number: NCT05671705
• Lead Sponsor: The Catholic University of Korea

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

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 Timeline

• Study First Submitted: 2022-11-24
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-05
• Study Start: 2023-01-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-26
• Last Update Posted: 2023-03-28
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke patients without sarcopenia	DEXA Scan	Group will be stratified according to gender
Stroke patients with sarcopenia	DEXA Scan	Group will be stratified according to gender

Primary Outcome Measures

Name	Time	Method
Change of Modified Rankin Scale	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).

Secondary Outcome Measures

Name	Time	Method
Hand grip strength	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
Functional Ambulation Category	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)
Thigh Dixon MRI	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
serum biomarkers for sarcopenia	within 4 weeks from the first onset of the stroke	BNDF, IL-6
quadriceps muscle strength	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
Muscle ultrasonography	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
Digitalized SEMG signals	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
Fugl-Meyer motor scale	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)
Berg balance scale	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)
Brain MRI	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

Trial Locations

Locations (2)

The Catholic University of Korea; 🇰🇷 Bucheon-si, Gyeonggi-do, Korea, Republic of

St. Vincent's Hospital; 🇰🇷 Suwon-si, Korea, Republic of