NCT07842731

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Oct 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

October 10, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2026

10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 21, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

Disability StatusMuscle StrengthMuscle MassPhysical ActivityFatigueFunctional Independence

Outcome Measures

Primary Outcomes (2)

  • Prevalence of Sarcopenia

    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

    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 Outcomes (7)

  • Handgrip Strength

    Baseline

  • Five-Times Sit-to-Stand Test

    Baseline

  • Sonographic Thigh Adjustment Ratio (STAR)

    Baseline

  • Sarcopenia Risk (SARC-F)

    Baseline

  • Modified Fatigue Impact Scale (MFIS)

    Baseline

  • +2 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Ankara Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Ozkeskin M, Ozden F, Ar E, Yuceyar N. The reliability and validity of the 30-second chair stand test and modified four square step test in persons with multiple sclerosis. Physiother Theory Pract. 2023 Oct 3;39(10):2189-2195. doi: 10.1080/09593985.2022.2070811. Epub 2022 Apr 26.

    PMID: 35471847BACKGROUND
  • Severijns D, Lamers I, Kerkhofs L, Feys P. Hand grip fatigability in persons with multiple sclerosis according to hand dominance and disease progression. J Rehabil Med. 2015 Feb;47(2):154-60. doi: 10.2340/16501977-1897.

    PMID: 25268997BACKGROUND
  • Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.

    PMID: 34121127BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisSarcopeniaMotor ActivityFatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Study Officials

  • Büşra Seçkinoğulları Korkusuz, PhD

    Ankara University

    PRINCIPAL INVESTIGATOR
  • Ayşenur Özcan

    Çankırı Karatekin University

    STUDY CHAIR
  • Süleyman Korkusuz

    Atılım University

    STUDY CHAIR
  • Ali M Özcan

    Baskent University

    STUDY CHAIR

Central Study Contacts

Süleyman Korkusuz, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 25, 2026

Study Start (Estimated)

October 10, 2026

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations