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Not yet recruitingNCT07842731MS-SarcopeniaUpdated Sep 25, 2026

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

An observational study in Multiple Sclerosis, Sarcopenia and Dynapenia, sponsored by Atılım University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Atılım University · Observational

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis
  • Sarcopenia
  • Dynapenia

Keywords

  • Disability Status
  • Muscle Strength
  • Muscle Mass
  • Physical Activity
  • Fatigue
  • Functional Independence
03

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 970 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Atılım University is the lead sponsor of 36 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

Secondary outcomes

  1. Handgrip Strength

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

    Time frame: Baseline

  2. Five-Times Sit-to-Stand Test

    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.

    Time frame: Baseline

  3. Sonographic Thigh Adjustment Ratio (STAR)

    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.

    Time frame: Baseline

  4. Sarcopenia Risk (SARC-F)

    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.

    Time frame: Baseline

  5. Modified Fatigue Impact Scale (MFIS)

    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.

    Time frame: Baseline

  6. Functional Independence Measure (FIM)

    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.

    Time frame: Baseline

  7. Barthel Index

    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.

    Time frame: Baseline

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 35471847 ↗
  • 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. PubMed 25268997 ↗
  • 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. PubMed 34121127 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2026
First posted
Sep 25, 2026
StartEst.
Oct 10, 2026
Primary completionEst.
Dec 10, 2026
CompletionEst.
Dec 20, 2026
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07842731
Lead sponsor
Atılım University
Collaborators
Baskent University Ankara Hospital
Responsible party
Süleyman Korkusuz (Assist. Prof. Dr, Atılım University) — Principal investigator
First posted
Sep 25, 2026
Start date
Oct 10, 2026 (estimated)
Primary completion
Dec 10, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Sep 25, 2026

Study contacts

Süleyman Korkusuz, PhD
Contact
suleyman.korkusuz@atilim.edu.tr
+905388675480
Büşra Seçkinoğulları Korkusuz, PhD
principal investigator · Ankara University
Ayşenur Özcan
study chair · Çankırı Karatekin University
Süleyman Korkusuz
study chair · Atılım University
Ali M Özcan
study chair · Baskent University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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