Sarcopenia and Related Factors in Patients With Multiple Sclerosis

Recruiting

• Conditions: Multiple Sclerosis; Sarcopenia

• Registration Number: NCT07116070
• Lead Sponsor: Selcuk University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-01
• Study First Submitted: 2025-07-24
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2026-01-20
• Study Completion: 2026-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body composition	Baseline	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.
Handgrip Strength	Baseline	This will be used to assess muscle strength. The validity and reliability of this test has been previously established in the literature.
6-Minute Walk Test	6 Minutes	This will be administered to assess physical performance. This test has been shown to be valid and reliable in neurological disease populations.
Mini Nutritional Assessment Form (MNA)	Baseline	This will be used to assess nutritional status.

Secondary Outcome Measures

Name	Time	Method
Demographic data and personal characteristics	Baseline	Demographic information such as sociodemographic characteristics, medications used, comorbidities, education level, occupation, smoking, alcohol use, past medical history, and family history of the individuals included in the study will be recorded.
Godin Leisure Time Exercise Questionnaire	Baseline	Will be applied to assess the level of physical activity.
Expanded Disability Status Scale (EDSS)	Baseline	This will be administered by a neurologist to determine the level of disability in MS patients.
Modified Fatigue Impact Scale (MFIS)	Baseline	This will be used to assess fatigue levels in MS patients. The validity and reliability of the Turkish version have been previously confirmed.
Multiple Sclerosis Quality of Life Scale-54	Baseline	This scale will be used to measure patients' quality of life. The MSQoL-54 scale is a tool specifically developed for MS patients.

Trial Locations

Locations (1)

Selcuk University Faculty of Medicine Hospital MS Life Center; 🇹🇷 Konya, Selcuklu, Turkey