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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Süleyman Korkusuz, PhD
- Número de teléfono: +905388675480
- Correo electrónico: suleyman.korkusuz@atilim.edu.tr
Ubicaciones de estudio
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Ankara, Turquía (Türkiye)
- Baskent University Ankara Hospital
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Contacto:
- Ali M Özcan, MSc
- Número de teléfono: 0535 776 08 84
- Correo electrónico: ozcanalimert1993@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Prevalence of Sarcopenia
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Handgrip Strength
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Ayşenur Özcan, Çankırı Karatekin University
- Investigador principal: Büşra Seçkinoğulları Korkusuz, PhD, Ankara University
- Silla de estudio: Süleyman Korkusuz, Atılım University
- Silla de estudio: Ali M Özcan, Baskent University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Manifestaciones Neuromusculares
- Condiciones Patológicas, Anatómicas
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Atrofia Muscular
- Atrofia
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Esclerosis múltiple
- Fatiga
- Sarcopenia
- Actividad del motor
Otros números de identificación del estudio
- E-59394181-100-137243
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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