Sarcopenia and Related Factors in Patients With Multiple Sclerosis

NCT ID: NCT07116070

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis Sarcopenia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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One group (Observational Cohort)

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

Clinical Assessments

Intervention Type 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.

Interventions

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Clinical Assessments

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Kaan ALTUNOK

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İsmail ÖZSOY, Assoc. Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Haluk GÜMÜŞ, Prof. Dr.

Role: STUDY_CHAIR

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

Gülşah ÖZSOY, Assist. Prof. Dr.

Role: STUDY_CHAIR

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

Zehra KORKUT, Assist. Prof. Dr.

Role: STUDY_CHAIR

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

Yasemin GEDİKLİ, Res. Asst.

Role: STUDY_CHAIR

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

Emel A ATAMAN AKTAŞ, Dr.

Role: STUDY_CHAIR

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

Omar E QUTOB, Dr.

Role: STUDY_CHAIR

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

Locations

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Selcuk University Faculty of Medicine Hospital MS Life Center

Konya, Selcuklu, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet K ALTUNOK, PHD(c) in PT

Role: CONTACT

5558175133 ext. +90

Facility Contacts

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Mehmet K ALTUNOK, PHD(c) in PT

Role: primary

5558175133 ext. +90

References

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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.

Reference Type BACKGROUND
PMID: 4053261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17183419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7613530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17293726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6685237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17942508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21624928 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37864991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39631136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34998245 (View on PubMed)

Other Identifiers

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SelcukU_PT_MS_SARCOPENIA

Identifier Type: -

Identifier Source: org_study_id

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