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NCT Number: NCT07116070

Sarcopenia and Related Factors in Patients With Multiple Sclerosis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University Faculty of Medicine Hospital MS Life Center

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

[email protected]

5558175133 ext. +90

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Body composition

    Time frame: 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.

  2. Handgrip Strength

    Time frame: Baseline

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

  3. 6-Minute Walk Test

    Time frame: 6 Minutes

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

  4. Mini Nutritional Assessment Form (MNA)

    Time frame: Baseline

    This will be used to assess nutritional status.

Secondary outcomes

  1. Demographic data and personal characteristics

    Time frame: 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.

  2. Godin Leisure Time Exercise Questionnaire

    Time frame: Baseline

    Will be applied to assess the level of physical activity.

  3. Expanded Disability Status Scale (EDSS)

    Time frame: Baseline

    This will be administered by a neurologist to determine the level of disability in MS patients.

  4. Modified Fatigue Impact Scale (MFIS)

    Time frame: Baseline

    This will be used to assess fatigue levels in MS patients. The validity and reliability of the Turkish version have been previously confirmed.

  5. Multiple Sclerosis Quality of Life Scale-54

    Time frame: Baseline

    This scale will be used to measure patients' quality of life. The MSQoL-54 scale is a tool specifically developed for MS patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

[email protected]

5558175133 ext. +90

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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