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NCT Number: NCT07842731

Investigation of the Prevalence of Sarcopenia and Dynapenia According to Disease Stage in Patients With Multiple Sclerosis and Evaluation of the Relationship Between Sarcopenia Severity and Clinical and Functional Parameters

This cross-sectional observational study aims to determine the prevalence of sarcopenia and dynapenia across disability stages in patients with multiple sclerosis (MS) and investigate their associations with clinical and functional parameters. Approximately 150 patients will be classified into two groups according to their Expanded Disability Status Scale (EDSS) scores: mild disability (EDSS < 4.0) and moderate disability (EDSS 4.0-6.5). Sarcopenia and dynapenia will be assessed using the ISarcoPRM algorithm. Physical activity, fatigue, and functional independence will also be evaluated.

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Key information

Conditions

Multiple Sclerosis Atrophy Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Dynapenia Fatigue Immune System Diseases Motor Activity 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–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baskent University Ankara Hospital

Ankara, Turkey (Türkiye)

About this study

Participants will undergo assessments of handgrip strength, five-times sit-to-stand performance, and ultrasound-based muscle mass using the Sonographic Thigh Adjustment Ratio (STAR). Sarcopenia and dynapenia will be classified according to the ISarcoPRM algorithm. Additional assessments will include the SARC-F questionnaire, smartwatch-derived physical activity, Modified Fatigue Impact Scale (MFIS), Functional Independence Measure (FIM), and Barthel Index. The prevalence of sarcopenia and dynapenia will be compared between disability groups, and associations with clinical and functional parameters will be examined.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 years or older.
  • Diagnosed with multiple sclerosis (MS) by a neurologist.
  • Standardized Mini-Mental State Examination (SMMSE) score ≥24.
  • Expanded Disability Status Scale (EDSS) score ≤6.5.
  • Willing to participate and provide written informed consent.

Exclusion criteria

  • Orthopedic surgery within the previous 3 months.
  • Botulinum toxin injection within the previous 3 months.
  • Severe cognitive impairment affecting the ability to complete assessments.
  • Severe cardiopulmonary disease.
  • Serious orthopedic or additional neurological conditions that may affect the assessments.
  • Severe pain (Visual Analog Scale [VAS] score >7).

Treatment and study plan

Primary outcomes

  1. Prevalence of Sarcopenia

    Time frame: Baseline

    Sarcopenia will be classified using the ISarcoPRM algorithm based on low muscle mass (STAR) combined with reduced handgrip strength and/or physical performance. Prevalence will be calculated as the percentage of participants meeting the criteria in each EDSS group.

  2. Prevalence of Dynapenia

    Time frame: Baseline

    Dynapenia will be defined as reduced muscle strength, independently of muscle mass, based on low handgrip strength (<32 kg for men; <19 kg for women) and/or prolonged five-times sit-to-stand time (≥12 seconds). Prevalence will be calculated as the percentage of participants meeting the criteria in each EDSS group.

Secondary outcomes

  1. Handgrip Strength

    Time frame: Baseline

    Handgrip strength will be measured using a calibrated hand dynamometer. The highest value from at least two trials will be recorded in kilograms (kg).

  2. Five-Times Sit-to-Stand Test

    Time frame: Baseline

    Participants will be asked to stand up and sit down five times without using their arms. Completion time will be recorded in seconds. A duration of 12 seconds or longer will indicate reduced physical performance.

  3. Sonographic Thigh Adjustment Ratio (STAR)

    Time frame: Baseline

    Anterior thigh muscle thickness will be assessed using ultrasonography and adjusted for body mass index to calculate STAR. Low muscle mass will be defined as STAR <1.0 in women and <1.4 in men.

  4. Sarcopenia Risk (SARC-F)

    Time frame: Baseline

    Sarcopenia risk will be assessed using the five-item SARC-F questionnaire. Total scores range from 0 to 10, with higher scores indicating greater risk. A score of 4 or higher indicates sarcopenia risk.

  5. Modified Fatigue Impact Scale (MFIS)

    Time frame: Baseline

    Fatigue will be assessed using the 21-item MFIS. Total scores range from 0 to 84, with higher scores indicating a greater impact of fatigue on daily functioning.

  6. Functional Independence Measure (FIM)

    Time frame: Baseline

    Functional independence will be assessed using the 18-item FIM. Total scores range from 18 to 126, with higher scores indicating greater independence in daily activities.

  7. Barthel Index

    Time frame: Baseline

    Independence in activities of daily living will be assessed using the Barthel Index. Total scores range from 0 to 100, with higher scores indicating greater functional independence.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Atılım University

Other

Collaborators

  • Baskent University Ankara Hospital

Registry information

Acronym: MS-Sarcopenia

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

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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