Sarcopenia and Related Factors in Patients With Multiple Sclerosis

NCT07116070 | Recruiting

• 1 other identifier: SelcukU_PT_MS_SARCOPENIA
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Sclerosis (MS) is a chronic disease affecting the central nervous system, exhibiting autoimmune and neurodegenerative properties. Neurological deficits, mobility limitations, and decreased muscle strength are commonly observed in MS patients as the disease progresses. The literature indicates that low physical activity levels and neurological deficits in individuals with MS can lead to decreased muscle mass and functional losses. Sarcopenia is a condition characterized by decreased skeletal muscle mass and strength associated with aging and chronic diseases, and studies on the prevalence of sarcopenia in MS patients are limited. Recent studies have revealed a high prevalence of sarcopenia in MS patients, which can have negative effects on physical performance, quality of life, and disease progression. Low muscle mass in MS patients can accelerate the loss of motor function and increase the level of disability. Additionally, nutritional deficiencies and low protein intake seen in MS patients are among the factors that accelerate muscle loss. Studies examining the relationship between MS and sarcopenia in the literature emphasize the importance of early diagnosis and intervention to improve patients' quality of life and functional independence. Factors such as muscle strength, physical activity level, and nutritional status should be assessed to determine the risk of sarcopenia in MS patients. This study was designed to determine the prevalence of sarcopenia in patients with Multiple Sclerosis (MS) and to examine the relationship between sarcopenia and fatigue, disability level (EDSS), nutritional status, and physical activity level. In this context:

• The prevalence of sarcopenia in MS patients will be determined,
• The relationship between sarcopenia and muscle strength, physical performance, and body composition will be evaluated,
• The effects of nutrition and physical activity on sarcopenia in MS patients will be investigated.

Conditions

Multiple Sclerosis; Sarcopenia

Keywords

multiple sclerosis; sarcopenia; muscle strength; physical performance; nutrition

Outcome Measures

Primary Outcomes (4)

• Body composition

  Body mass and body composition will be measured with the help of Tanita brand device using bioelectrical impedance method. Information provided by the patient, such as height, age, gender, and physical activity level, is manually entered into the device. The device then transmits a very low level, harmless electrical current into the body and automatically analyzes body composition based on the transit time of this current. Parameters to be evaluated in body composition; body mass index (BMI = body mass: (kg)/height2 (m)2), fat mass expressed as a percentage of body mass (pFM), fat-free mass (FFM) expressed in kilograms and appendicular skeletal muscle mass (ASMM) and skeletal muscle mass (SMM) expressed in kilograms. The device automatically provides all the specified parameters during a single measurement. The measurements will be recorded on the previously prepared form.

  Baseline

• Handgrip Strength

  This will be used to assess muscle strength. The validity and reliability of this test has been previously established in the literature.

  Baseline

• 6-Minute Walk Test

  This will be administered to assess physical performance. This test has been shown to be valid and reliable in neurological disease populations.

  6 Minutes

• Mini Nutritional Assessment Form (MNA)

  This will be used to assess nutritional status.

  Baseline

Secondary Outcomes (5)

• Demographic data and personal characteristics

  Baseline

• Godin Leisure Time Exercise Questionnaire

  Baseline

• Expanded Disability Status Scale (EDSS)

  Baseline

• Modified Fatigue Impact Scale (MFIS)

  Baseline

• Multiple Sclerosis Quality of Life Scale-54

  Baseline

Study Arms (1)

One group (Observational Cohort)

MS patients (18 years and older) followed in the clinic.

Other: Clinical Assessments

Interventions

Clinical Assessments OTHER

Participants will undergo the following assessments: * Muscle strength: Handgrip strength test (using a digital dynamometer), * Muscle mass: Bioelectrical impedance analysis (BIA) or DXA, * Physical performance: 6-minute walk test, 5-repetition sit-to-stand test, * Fatigue: Modified Fatigue Impact Scale (MFIS), * Disability: EDSS, * Nutritional status: Mini Nutritional Assessment (MNA), * Physical activity: Godin Leisure-Time Exercise Questionnaire, * Quality of life: MSQoL-54.

One group (Observational Cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with MS who applied to the Selçuk University Faculty of Medicine Hospital MS Living Center

You may qualify if:

• Being 18 years of age or older,
• Having been diagnosed with Multiple Sclerosis (confirmed by a neurologist),
• Being in a stable phase of the disease (having not had an attack in the last 3 months),
• Having preserved walking ability (EDSS score ≤6.5),
• Being able to give informed consent to participate in the study.

You may not qualify if:

• Having another neuromuscular disease.
• Having developed significant muscle loss within the last 6 months due to use of corticosteroids or immunosuppressive therapy.
• Having systemic diseases that can cause muscle loss, such as cancer, rheumatic diseases, or severe metabolic disorders.
• Having undergone major surgery or a history of serious trauma within the last 3 months.
• Being pregnant or breastfeeding.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University Faculty of Medicine Hospital MS Life Center

Konya, Selcuklu, 42130, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

  PMID: 4053261 BACKGROUND

• Guigoz Y. The Mini Nutritional Assessment (MNA) review of the literature--What does it tell us? J Nutr Health Aging. 2006 Nov-Dec;10(6):466-85; discussion 485-7.

  PMID: 17183419 BACKGROUND

• Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.

  PMID: 7613530 BACKGROUND

• Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.

  PMID: 17293726 BACKGROUND

• Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.

  PMID: 6685237 BACKGROUND

• Goldman MD, Marrie RA, Cohen JA. Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Mult Scler. 2008 Apr;14(3):383-90. doi: 10.1177/1352458507082607. Epub 2007 Oct 17.

  PMID: 17942508 BACKGROUND

• Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.

  PMID: 21624928 BACKGROUND

• Carvalho BM, Silva RSC, Lima VVM, Almondes KGS, Rodrigues FNS, D'Almeida JAC, Melo MLP. Excess weight increases the risk of sarcopenia in patients with multiple sclerosis. Mult Scler Relat Disord. 2023 Nov;79:105049. doi: 10.1016/j.msard.2023.105049. Epub 2023 Oct 8.

  PMID: 37864991 BACKGROUND

• Gaemelke T, Pedersen IS, Dalgas U, Hvid LG. Sarcopenia in older people with multiple sclerosis: A cross-sectional study. Mult Scler Relat Disord. 2025 Jan;93:106190. doi: 10.1016/j.msard.2024.106190. Epub 2024 Nov 25.

  PMID: 39631136 BACKGROUND

• Yuksel H, Balaban M, Tan OO, Mungan S. Sarcopenia in patients with multiple sclerosis. Mult Scler Relat Disord. 2022 Feb;58:103471. doi: 10.1016/j.msard.2021.103471. Epub 2021 Dec 26.

  PMID: 34998245 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Sarcopenia

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• İsmail ÖZSOY, Assoc. Prof. Dr.

  Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  PRINCIPAL INVESTIGATOR

• Haluk GÜMÜŞ, Prof. Dr.

  Selçuk University, Faculty of Medicine, Department of Neurology, Konya, Türkiye

  STUDY CHAIR

• Gülşah ÖZSOY, Assist. Prof. Dr.

  Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  STUDY CHAIR

• Zehra KORKUT, Assist. Prof. Dr.

  Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  STUDY CHAIR

• Yasemin GEDİKLİ, Res. Asst.

  Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  STUDY CHAIR

• Emel A ATAMAN AKTAŞ, Dr.

  Selçuk University, Faculty of Medicine, Department of Neurology, Konya, Türkiye

  STUDY CHAIR

• Omar E QUTOB, Dr.

  Selçuk University, Faculty of Medicine, Department of Neurology, Konya, Türkiye

  STUDY CHAIR

Central Study Contacts

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

5558175133; mehmetkaan.altunok@selcuk.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 11, 2025
• Study Start: June 1, 2025
• Primary Completion: January 20, 2026
• Study Completion: March 20, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)