Multiple SclerosisMS-SarcopeniaNCT07842731
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 of Multiple Sclerosis and Sarcopenia, run by Atılım University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Sarcopenia, Dynapenia
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2026to 20 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Baskent University Ankara Hospital
Ankara
Ali M Özcan, MSc, 0535 776 08 84, ozcanalimert1993@gmail.com
About this study
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.
- Conditions
- Multiple Sclerosis, Sarcopenia, Dynapenia
- Keywords
- Disability Status, Muscle Strength, Muscle Mass, Physical Activity, Fatigue, Functional Independence
- Medical subject headings
- Multiple Sclerosis, Sarcopenia, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (7)
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).
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University Ankara Hospital
- Responsible party
- Principal investigator, Süleyman Korkusuz, Atılım University
- Investigators
- Büşra Seçkinoğulları Korkusuz, PhD, Principal investigator, Ankara UniversityAyşenur Özcan, Study chair, Çankırı Karatekin UniversitySüleyman Korkusuz, Study chair, Atılım UniversityAli M Özcan, Study chair, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842731
- Sponsor's protocol ID
- E-59394181-100-137243
- Acronym
- MS-Sarcopenia
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35471847Severijns 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 25268997Kara 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07842731
- Acronym / sponsor ID
- MS-Sarcopenia / E-59394181-100-137243
- Conditions
- Multiple Sclerosis, Sarcopenia, Dynapenia
- Keywords
- Disability Status, Muscle Strength, Muscle Mass, Physical Activity, Fatigue, Functional Independence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Collaborators
- Baskent University Ankara Hospital
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
7 secondary outcomes
Handgrip Strength
Time frame: Baseline
Five-Times Sit-to-Stand Test
Time frame: Baseline
Sonographic Thigh Adjustment Ratio (STAR)
Time frame: Baseline
Sarcopenia Risk (SARC-F)
Time frame: Baseline
Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline
Functional Independence Measure (FIM)
Time frame: Baseline
Barthel Index
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 35471847Ozkeskin 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.
- Background: PubMed 25268997Severijns 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.
- Background: PubMed 34121127Kara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Büşra Seçkinoğulları Korkusuz, PhD principal investigator
Ankara University
Ayşenur Özcan study chair
Çankırı Karatekin University
Süleyman Korkusuz study chair
Atılım University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Sarcopenia, run by Atılım University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Süleyman Korkusuz, PhD (+905388675480, suleyman.korkusuz@atilim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Sarcopenia (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07842731, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.