- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07842731
Investigation of the Prevalence of Sarcopenia and Dynapenia According to Disease Stage in Patients With Multiple Sclerosis and Evaluation of the Relationship Between Sarcopenia Severity and Clinical and Functional Parameters (MS-Sarcopenia)
This cross-sectional observational study aims to determine the prevalence of sarcopenia and dynapenia across disability stages in patients with multiple sclerosis (MS) and investigate their associations with clinical and functional parameters. Approximately 150 patients will be classified into two groups according to their Expanded Disability Status Scale (EDSS) scores: mild disability (EDSS < 4.0) and moderate disability (EDSS 4.0-6.5). Sarcopenia and dynapenia will be assessed using the ISarcoPRM algorithm. Physical activity, fatigue, and functional independence will also be evaluated.
연구 개요
상세 설명
Participants will undergo assessments of handgrip strength, five-times sit-to-stand performance, and ultrasound-based muscle mass using the Sonographic Thigh Adjustment Ratio (STAR). Sarcopenia and dynapenia will be classified according to the ISarcoPRM algorithm. Additional assessments will include the SARC-F questionnaire, smartwatch-derived physical activity, Modified Fatigue Impact Scale (MFIS), Functional Independence Measure (FIM), and Barthel Index. The prevalence of sarcopenia and dynapenia will be compared between disability groups, and associations with clinical and functional parameters will be examined.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Süleyman Korkusuz, PhD
- 전화번호: +905388675480
- 이메일: suleyman.korkusuz@atilim.edu.tr
연구 장소
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Ankara, 터키 (Türkiye)
- Baskent University Ankara Hospital
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연락하다:
- Ali M Özcan, MSc
- 전화번호: 0535 776 08 84
- 이메일: ozcanalimert1993@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Approximately 150 adults diagnosed with multiple sclerosis (MS) receiving care at the Physiotherapy and Rehabilitation Unit of Başkent University Hospital. Participants will be classified into mild (EDSS <4.0) and moderate (EDSS 4.0-6.5) disability groups.
설명
Inclusion Criteria:
- Aged 18 years or older.
- Diagnosed with multiple sclerosis (MS) by a neurologist.
- Standardized Mini-Mental State Examination (SMMSE) score ≥24.
- Expanded Disability Status Scale (EDSS) score ≤6.5.
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- Orthopedic surgery within the previous 3 months.
- Botulinum toxin injection within the previous 3 months.
- Severe cognitive impairment affecting the ability to complete assessments.
- Severe cardiopulmonary disease.
- Serious orthopedic or additional neurological conditions that may affect the assessments.
- Severe pain (Visual Analog Scale [VAS] score >7).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
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Mild Disability MS
Patients with multiple sclerosis with an Expanded Disability Status Scale (EDSS) score below 4.0. |
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Moderate Disability MS
Patients with multiple sclerosis with an Expanded Disability Status Scale (EDSS) score between 4.0 and 6.5. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Prevalence of Sarcopenia
기간: Baseline
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Sarcopenia will be classified using the ISarcoPRM algorithm based on low muscle mass (STAR) combined with reduced handgrip strength and/or physical performance. Prevalence will be calculated as the percentage of participants meeting the criteria in each EDSS group. |
Baseline
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Prevalence of Dynapenia
기간: Baseline
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Dynapenia will be defined as reduced muscle strength, independently of muscle mass, based on low handgrip strength (<32 kg for men; <19 kg for women) and/or prolonged five-times sit-to-stand time (≥12 seconds). Prevalence will be calculated as the percentage of participants meeting the criteria in each EDSS group. |
Baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Handgrip Strength
기간: Baseline
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Handgrip strength will be measured using a calibrated hand dynamometer. The highest value from at least two trials will be recorded in kilograms (kg). |
Baseline
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Five-Times Sit-to-Stand Test
기간: Baseline
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Participants will be asked to stand up and sit down five times without using their arms. Completion time will be recorded in seconds. A duration of 12 seconds or longer will indicate reduced physical performance. |
Baseline
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Sonographic Thigh Adjustment Ratio (STAR)
기간: Baseline
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Anterior thigh muscle thickness will be assessed using ultrasonography and adjusted for body mass index to calculate STAR. Low muscle mass will be defined as STAR <1.0 in women and <1.4 in men. |
Baseline
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Sarcopenia Risk (SARC-F)
기간: Baseline
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Sarcopenia risk will be assessed using the five-item SARC-F questionnaire. Total scores range from 0 to 10, with higher scores indicating greater risk. A score of 4 or higher indicates sarcopenia risk. |
Baseline
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Modified Fatigue Impact Scale (MFIS)
기간: Baseline
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Fatigue will be assessed using the 21-item MFIS. Total scores range from 0 to 84, with higher scores indicating a greater impact of fatigue on daily functioning. |
Baseline
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Functional Independence Measure (FIM)
기간: Baseline
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Functional independence will be assessed using the 18-item FIM. Total scores range from 18 to 126, with higher scores indicating greater independence in daily activities. |
Baseline
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Barthel Index
기간: Baseline
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Independence in activities of daily living will be assessed using the Barthel Index. Total scores range from 0 to 100, with higher scores indicating greater functional independence. |
Baseline
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공동 작업자 및 조사자
수사관
- 연구 의자: Ayşenur Özcan, Çankırı Karatekin University
- 수석 연구원: Büşra Seçkinoğulları Korkusuz, PhD, Ankara University
- 연구 의자: Süleyman Korkusuz, Atılım University
- 연구 의자: Ali M Özcan, Baskent University
간행물 및 유용한 링크
일반 간행물
- Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.
- Severijns D, Lamers I, Kerkhofs L, Feys P. Hand grip fatigability in persons with multiple sclerosis according to hand dominance and disease progression. J Rehabil Med. 2015 Feb;47(2):154-60. doi: 10.2340/16501977-1897.
- Ozkeskin M, Ozden F, Ar E, Yuceyar N. The reliability and validity of the 30-second chair stand test and modified four square step test in persons with multiple sclerosis. Physiother Theory Pract. 2023 Oct 3;39(10):2189-2195. doi: 10.1080/09593985.2022.2070811. Epub 2022 Apr 26.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- E-59394181-100-137243
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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