Multiple SclerosisNCT07116070
Sarcopenia and Related Factors in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis and Sarcopenia, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Multiple Sclerosis (MS) is a chronic disease affecting the central nervous system, exhibiting autoimmune and neurodegenerative properties. Neurological deficits, mobility limitations, and decreased muscle strength are commonly observed in MS patients as the disease progresses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Sarcopenia
- What is being tested?
- Clinical Assessments
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 20 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with MS who applied to the Selçuk University Faculty of Medicine Hospital MS Living Center
Who may be able to join
- Being 18 years of age or older,
- Having been diagnosed with Multiple Sclerosis (confirmed by a neurologist),
- Being in a stable phase of the disease (having not had an attack in the last 3 months),
- Having preserved walking ability (EDSS score ≤6.5),
- Being able to give informed consent to participate in the study.
Who cannot join
- Having another neuromuscular disease.
- Having developed significant muscle loss within the last 6 months due to use of corticosteroids or immunosuppressive therapy.
- Having systemic diseases that can cause muscle loss, such as cancer, rheumatic diseases, or severe metabolic disorders.
- Having undergone major surgery or a history of serious trauma within the last 3 months.
- Being pregnant or breastfeeding.
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, 1 recruiting
- Recruiting
Selcuk University Faculty of Medicine Hospital MS Life Center
Konya, Selcuklu, 42130
Mehmet K ALTUNOK, PHD(c) in PT, 5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr
About this study
Multiple Sclerosis (MS) is a chronic disease affecting the central nervous system, exhibiting autoimmune and neurodegenerative properties. Neurological deficits, mobility limitations, and decreased muscle strength are commonly observed in MS patients as the disease progresses. The literature indicates that low physical activity levels and neurological deficits in individuals with MS can lead to decreased muscle mass and functional losses. Sarcopenia is a condition characterized by decreased skeletal muscle mass and strength associated with aging and chronic diseases, and studies on the prevalence of sarcopenia in MS patients are limited.
Recent studies have revealed a high prevalence of sarcopenia in MS patients, which can have negative effects on physical performance, quality of life, and disease progression. Low muscle mass in MS patients can accelerate the loss of motor function and increase the level of disability. Additionally, nutritional deficiencies and low protein intake seen in MS patients are among the factors that accelerate muscle loss.
Read more
Studies examining the relationship between MS and sarcopenia in the literature emphasize the importance of early diagnosis and intervention to improve patients' quality of life and functional independence. Factors such as muscle strength, physical activity level, and nutritional status should be assessed to determine the risk of sarcopenia in MS patients.
This study was designed to determine the prevalence of sarcopenia in patients with Multiple Sclerosis (MS) and to examine the relationship between sarcopenia and fatigue, disability level (EDSS), nutritional status, and physical activity level.
In this context:
- The prevalence of sarcopenia in MS patients will be determined,
- The relationship between sarcopenia and muscle strength, physical performance, and body composition will be evaluated,
- The effects of nutrition and physical activity on sarcopenia in MS patients will be investigated.
- Conditions
- Multiple Sclerosis, Sarcopenia
- Being tested
- Clinical Assessments
- Keywords
- multiple sclerosis, sarcopenia, muscle strength, physical performance, nutrition
- Medical subject headings
- Multiple Sclerosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical AssessmentsOther
Participants will undergo the following assessments:
- Muscle strength: Handgrip strength test (using a digital dynamometer),
- Muscle mass: Bioelectrical impedance analysis (BIA) or DXA,
- Physical performance: 6-minute walk test, 5-repetition sit-to-stand test,
- Fatigue: Modified Fatigue Impact Scale (MFIS),
- Disability: EDSS,
- Nutritional status: Mini Nutritional Assessment (MNA),
- Physical activity: Godin Leisure-Time Exercise Questionnaire,
- Quality of life: MSQoL-54.
| Study group | Role | What they receive |
|---|---|---|
| One group (Observational Cohort) | MS patients (18 years and older) followed in the clinic. Receives: Other: Clinical Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Body mass and body composition will be measured with the help of Tanita brand device using bioelectrical impedance method. Information provided by the patient, such as height, age, gender, and physical activity level, is manually entered into the device. The device then transmits a very low level, harmless electrical current into the body and automatically analyzes body composition based on the transit time of this current. Parameters to be evaluated in body composition; body mass index (BMI = body mass: (kg)/height2 (m)2), fat mass expressed as a percentage of body mass (pFM), fat-free mass (FFM) expressed in kilograms and appendicular skeletal muscle mass (ASMM) and skeletal muscle mass (SMM) expressed in kilograms. The device automatically provides all the specified parameters during a single measurement. The measurements will be recorded on the previously prepared form.
Measured: Baseline
Handgrip Strength
This will be used to assess muscle strength. The validity and reliability of this test has been previously established in the literature.
Measured: Baseline
6-Minute Walk Test
This will be administered to assess physical performance. This test has been shown to be valid and reliable in neurological disease populations.
Measured: 6 Minutes
Mini Nutritional Assessment Form (MNA)
This will be used to assess nutritional status.
Measured: Baseline
Secondary outcomes (5)
Demographic data and personal characteristics
Demographic information such as sociodemographic characteristics, medications used, comorbidities, education level, occupation, smoking, alcohol use, past medical history, and family history of the individuals included in the study will be recorded.
Measured: Baseline
Godin Leisure Time Exercise Questionnaire
Will be applied to assess the level of physical activity.
Measured: Baseline
Expanded Disability Status Scale (EDSS)
This will be administered by a neurologist to determine the level of disability in MS patients.
Measured: Baseline
Modified Fatigue Impact Scale (MFIS)
This will be used to assess fatigue levels in MS patients. The validity and reliability of the Turkish version have been previously confirmed.
Measured: Baseline
Multiple Sclerosis Quality of Life Scale-54
This scale will be used to measure patients' quality of life. The MSQoL-54 scale is a tool specifically developed for MS patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jun 2025
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kaan ALTUNOK, Selcuk University
- Investigators
- İsmail ÖZSOY, Assoc. Prof. Dr., Principal investigator, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, TürkiyeHaluk GÜMÜŞ, Prof. Dr., Study chair, Selçuk University, Faculty of Medicine, Department of Neurology, Konya, TürkiyeGülşah ÖZSOY, Assist. Prof. Dr., Study chair, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, TürkiyeZehra KORKUT, Assist. Prof. Dr., Study chair, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, TürkiyeYasemin GEDİKLİ, Res. Asst., Study chair, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, TürkiyeEmel A ATAMAN AKTAŞ, Dr., Study chair, Selçuk University, Faculty of Medicine, Department of Neurology, Konya, TürkiyeOmar E QUTOB, Dr., Study chair, Selçuk University, Faculty of Medicine, Department of Neurology, Konya, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116070
- Sponsor's protocol ID
- SelcukU_PT_MS_SARCOPENIA
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
PubMed 4053261Guigoz Y. The Mini Nutritional Assessment (MNA) review of the literature--What does it tell us? J Nutr Health Aging. 2006 Nov-Dec;10(6):466-85; discussion 485-7.
PubMed 17183419Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.
PubMed 7613530Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.
PubMed 17293726Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
PubMed 6685237Goldman MD, Marrie RA, Cohen JA. Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Mult Scler. 2008 Apr;14(3):383-90. doi: 10.1177/1352458507082607. Epub 2007 Oct 17.
PubMed 17942508Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
PubMed 21624928Carvalho BM, Silva RSC, Lima VVM, Almondes KGS, Rodrigues FNS, D'Almeida JAC, Melo MLP. Excess weight increases the risk of sarcopenia in patients with multiple sclerosis. Mult Scler Relat Disord. 2023 Nov;79:105049. doi: 10.1016/j.msard.2023.105049. Epub 2023 Oct 8.
PubMed 37864991Gaemelke T, Pedersen IS, Dalgas U, Hvid LG. Sarcopenia in older people with multiple sclerosis: A cross-sectional study. Mult Scler Relat Disord. 2025 Jan;93:106190. doi: 10.1016/j.msard.2024.106190. Epub 2024 Nov 25.
PubMed 39631136Yuksel H, Balaban M, Tan OO, Mungan S. Sarcopenia in patients with multiple sclerosis. Mult Scler Relat Disord. 2022 Feb;58:103471. doi: 10.1016/j.msard.2021.103471. Epub 2021 Dec 26.
PubMed 34998245
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia and Related Factors in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07116070
- Acronym / sponsor ID
- SelcukU_PT_MS_SARCOPENIA
- Conditions
- Multiple Sclerosis, Sarcopenia
- Keywords
- multiple sclerosis, sarcopenia, muscle strength, physical performance, nutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 11 Aug 2025 (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.
Multiple Sclerosis (MS) is a chronic disease affecting the central nervous system, exhibiting autoimmune and neurodegenerative properties. Neurological deficits, mobility limitations, and decreased muscle strength are commonly observed in MS patients as the disease progresses. The literature indicates that low physical activity levels and neurological deficits in individuals with MS can lead to decreased muscle mass and functional losses. Sarcopenia is a condition characterized by decreased skeletal muscle mass and strength associated with aging and chronic diseases, and studies on the prevalence of sarcopenia in MS patients are limited.
Recent studies have revealed a high prevalence of sarcopenia in MS patients, which can have negative effects on physical performance, quality of life, and disease progression. Low muscle mass in MS patients can accelerate the loss of motor function and increase the level of disability. Additionally, nutritional deficiencies and low protein intake seen in MS patients are among the factors that accelerate muscle loss.
Studies examining the relationship between MS and sarcopenia in the literature emphasize the importance of early diagnosis and intervention to improve patients' quality of life and functional independence. Factors such as muscle strength, physical activity level, and nutritional status should be assessed to determine the risk of sarcopenia in MS patients.
This study was designed to determine the prevalence of sarcopenia in patients with Multiple Sclerosis (MS) and to examine the relationship between sarcopenia and fatigue, disability level (EDSS), nutritional status, and physical activity level.
In this context:
- The prevalence of sarcopenia in MS patients will be determined,
- The relationship between sarcopenia and muscle strength, physical performance, and body composition will be evaluated,
- The effects of nutrition and physical activity on sarcopenia in MS patients will be investigated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group (Observational Cohort) | – | Other: Clinical AssessmentsMS patients (18 years and older) followed in the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with MS who applied to the Selçuk University Faculty of Medicine Hospital MS Living Center
Key inclusion criteria (5 listed)
- Being 18 years of age or older,
- Having been diagnosed with Multiple Sclerosis (confirmed by a neurologist),
- Being in a stable phase of the disease (having not had an attack in the last 3 months),
- Having preserved walking ability (EDSS score ≤6.5),
- Being able to give informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Having another neuromuscular disease.
- Having developed significant muscle loss within the last 6 months due to use of corticosteroids or immunosuppressive therapy.
- Having systemic diseases that can cause muscle loss, such as cancer, rheumatic diseases, or severe metabolic disorders.
- Having undergone major surgery or a history of serious trauma within the last 3 months.
- Being pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical AssessmentsParticipants will undergo the following assessments: * Muscle strength: Handgrip strength test (using a digital dynamometer), * Muscle mass: Bioelectrical impedance analysis (BIA) or DXA, * Physical performance: 6-minute walk test, 5-repetition sit-to-stand test, * Fatigue: Modified Fatigue Impact Scale (MFIS), * Disability: EDSS, * Nutritional status: Mini Nutritional Assessment (MNA), * Physical activity: Godin Leisure-Time Exercise Questionnaire, * Quality of life: MSQoL-54. | Other | One group (Observational Cohort) |
Primary outcome
Body composition
Time frame: Baseline
Body mass and body composition will be measured with the help of Tanita brand device using bioelectrical impedance method. Information provided by the patient, such as height, age, gender, and physical activity level, is manually entered into the device. The device then transmits a very low level, harmless electrical current into the body and automatically analyzes body composition based on the transit time of this current. Parameters to be evaluated in body composition; body mass index (BMI = body mass: (kg)/height2 (m)2), fat mass expressed as a percentage of body mass (pFM), fat-free mass (FFM) expressed in kilograms and appendicular skeletal muscle mass (ASMM) and skeletal muscle mass (SMM) expressed in kilograms. The device automatically provides all the specified parameters during a single measurement. The measurements will be recorded on the previously prepared form.
Handgrip Strength
Time frame: Baseline
This will be used to assess muscle strength. The validity and reliability of this test has been previously established in the literature.
6-Minute Walk Test
Time frame: 6 Minutes
This will be administered to assess physical performance. This test has been shown to be valid and reliable in neurological disease populations.
Mini Nutritional Assessment Form (MNA)
Time frame: Baseline
This will be used to assess nutritional status.
5 secondary outcomes
Demographic data and personal characteristics
Time frame: Baseline
Godin Leisure Time Exercise Questionnaire
Time frame: Baseline
Expanded Disability Status Scale (EDSS)
Time frame: Baseline
Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline
Multiple Sclerosis Quality of Life Scale-54
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 11 Aug 2025.
- Background: PubMed 4053261Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
- Background: PubMed 17183419Guigoz Y. The Mini Nutritional Assessment (MNA) review of the literature--What does it tell us? J Nutr Health Aging. 2006 Nov-Dec;10(6):466-85; discussion 485-7.
- Background: PubMed 7613530Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.
- Background: PubMed 17293726Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.
- Background: PubMed 6685237Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
- Background: PubMed 17942508Goldman MD, Marrie RA, Cohen JA. Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Mult Scler. 2008 Apr;14(3):383-90. doi: 10.1177/1352458507082607. Epub 2007 Oct 17.
- Background: PubMed 21624928Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
- Background: PubMed 37864991Carvalho BM, Silva RSC, Lima VVM, Almondes KGS, Rodrigues FNS, D'Almeida JAC, Melo MLP. Excess weight increases the risk of sarcopenia in patients with multiple sclerosis. Mult Scler Relat Disord. 2023 Nov;79:105049. doi: 10.1016/j.msard.2023.105049. Epub 2023 Oct 8.
- Background: PubMed 39631136Gaemelke T, Pedersen IS, Dalgas U, Hvid LG. Sarcopenia in older people with multiple sclerosis: A cross-sectional study. Mult Scler Relat Disord. 2025 Jan;93:106190. doi: 10.1016/j.msard.2024.106190. Epub 2024 Nov 25.
- Background: PubMed 34998245Yuksel H, Balaban M, Tan OO, Mungan S. Sarcopenia in patients with multiple sclerosis. Mult Scler Relat Disord. 2022 Feb;58:103471. doi: 10.1016/j.msard.2021.103471. Epub 2021 Dec 26.
- 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.
İsmail ÖZSOY, Assoc. Prof. Dr. principal investigator
Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
Haluk GÜMÜŞ, Prof. Dr. study chair
Selçuk University, Faculty of Medicine, Department of Neurology, Konya, Türkiye
Gülşah ÖZSOY, Assist. Prof. Dr. study chair
Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
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 Selcuk 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 5 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: looking for participants now, as of the sponsor's last update on 11 Aug 2025. 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 Mehmet K ALTUNOK, PHD(c) in PT (5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: Baseline). The study lists 4 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 NCT07116070, which also lists 10 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 11 Aug 2025.