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 (MS-Sarcopenia)

September 21, 2026 updated by: Süleyman Korkusuz, Atılım University

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 150 adults diagnosed with multiple sclerosis (MS) receiving care at the Physiotherapy and Rehabilitation Unit of Başkent University Hospital. Participants will be classified into mild (EDSS <4.0) and moderate (EDSS 4.0-6.5) disability groups.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort
Mild Disability MS

Patients with multiple sclerosis with an Expanded Disability Status Scale (EDSS) score below 4.0.
Moderate Disability MS

Patients with multiple sclerosis with an Expanded Disability Status Scale (EDSS) score between 4.0 and 6.5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atılım University

Collaborators

Baskent University Ankara Hospital

Investigators

  • Study Chair: Ayşenur Özcan, Çankırı Karatekin University
  • Principal Investigator: Büşra Seçkinoğulları Korkusuz, PhD, Ankara University
  • Study Chair: Süleyman Korkusuz, Atılım University
  • Study Chair: Ali M Özcan, Baskent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 10, 2026

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

December 20, 2026

Study Registration Dates

First Submitted

September 21, 2026

First Submitted That Met QC Criteria

September 21, 2026

First Posted (Actual)

September 25, 2026

Study Record Updates

Last Update Posted (Actual)

September 25, 2026

Last Update Submitted That Met QC Criteria

September 21, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-59394181-100-137243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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