Menu
Recruiting NCT07116070

Sarcopenia and Related Factors in Patients With Multiple Sclerosis

— Observational Multiple Sclerosis Sarcopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical Assessments.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Sarcopenia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Body composition [Time frame: Baseline]
  • Handgrip Strength [Time frame: Baseline]
  • 6-Minute Walk Test [Time frame: 6 Minutes]
  • Mini Nutritional Assessment Form (MNA) [Time frame: Baseline]
Secondary outcome measures (5)
  • Demographic data and personal characteristics [Time frame: Baseline]
  • Godin Leisure Time Exercise Questionnaire [Time frame: Baseline]
  • Expanded Disability Status Scale (EDSS) [Time frame: Baseline]
  • Modified Fatigue Impact Scale (MFIS) [Time frame: Baseline]
  • Multiple Sclerosis Quality of Life Scale-54 [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Selcuk University Faculty of Medicine Hospital MS Life Center — Konya

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07116070 · SelcukU_PT_MS_SARCOPENIA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗