MULTIPL SCLEROSİSNCT07521982
Comparison of Frailty, Physical Fitness Parameters, and Irisin Levels Between Patients With Multiple Sclerosis and Healthy Volunteers
An observational study of MULTIPL SCLEROSİS, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Multiple Sclerosis (MS) is a chronic immune-mediated and neurodegenerative disease of the central nervous system that often affects young adults and is more common in women. In addition to neurological disability, individuals with MS frequently experience frailty, a condition characterized by reduced physiological… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- MULTIPL SCLEROSİS
- How many people
- 782 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 30 Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18-65 diagnosed with MS who applied to the Başkent University Alanya Hospital Center Physical Medicine and Rehabilitation outpatient clinic between April 1, 2026, and May 30 2026, and healthy volunteers aged 18-65 years with similar demographic characteristics (age, gender, etc.) will be included.
Who may be able to join
- Patients aged 18-65 evaluated by neurology and diagnosed with definitive MS via objective methods (MRI, lumbar puncture, etc.).
- Healthy volunteers aged 18-65.
- Being literate in Turkish.
- Participants who provide a consent form to participate in the study.
Who cannot join
- Being younger than 18 or older than 65.
- Presence of any concomitant neurological disease other than MS.
- Presence of an uncontrolled systemic disease at a level that would affect the evaluation.
- Presence of cognitive impairment or psychiatric illness at a level that would affect the evaluation.
- Having had an MS attack or received steroid treatment in the last month.
- Presence of an orthopedic disability that prevents evaluations.
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 Alanya Hospital
Antalya, Alanya, 07400
Ozlem Kuculmez, Asist Prof Dr, +905555620521 ext. +905555620521, akanozlem07@gmail.com
Sevgi Ikbali Afsar, Prof. dr., +905388868596 ext. +905388868596, ikbaliafsar@hotmail.com
About this study
Multiple Sclerosis (MS) is a chronic immune-mediated and neurodegenerative disease of the central nervous system that often affects young adults and is more common in women. In addition to neurological disability, individuals with MS frequently experience frailty, a condition characterized by reduced physiological reserve, weakness, fatigue, decreased physical activity, and increased vulnerability to stressors. Frailty in MS is associated with poorer mobility, higher fall risk, reduced quality of life, and increased healthcare utilization. Irisin, a hormone released from skeletal muscles during exercise, is linked to energy metabolism and muscle function, and lower levels have been associated with reduced physical performance and sarcopenia. However, the relationship between frailty, physical fitness, and irisin levels in individuals with MS has not been sufficiently explored.
This study aims to compare frailty status, physical fitness parameters, and circulating irisin levels between patients with MS and healthy volunteers aged 18-65 years. Participants will undergo assessments including the Functional Independence Measure, Frailty Index, Berg Balance Scale, 6-Minute Walk Test, and handgrip strength measurement. Blood samples will also be collected to determine irisin levels using the ELISA method. Statistical analyses will evaluate differences between groups and correlations among frailty, functional performance, and irisin levels. The findings are expected to improve understanding of frailty mechanisms in MS and contribute to developing targeted rehabilitation and management strategies.
Read the detailed description
Multiple Sclerosis (MS) is a chronic, immune-mediated, and neurodegenerative disorder of the central nervous system, characterized by inflammation, demyelination, and progressive axonal damage. It predominantly affects young adults and has a higher prevalence among women. The disease course is highly variable, often leading to a wide range of physical, cognitive, and psychosocial impairments that can significantly impact daily functioning and long-term quality of life.
In addition to neurological disability, individuals with MS frequently experience frailty, a multidimensional clinical syndrome marked by diminished physiological reserve and reduced resilience to internal and external stressors. Frailty is typically characterized by symptoms such as generalized weakness, persistent fatigue, decreased physical activity, slowed motor performance, and increased vulnerability to adverse health outcomes. In the context of MS, frailty represents an important but underrecognized condition that may exacerbate disease burden and accelerate functional decline.
The presence of frailty in individuals with MS has been associated with poorer mobility, impaired balance, increased risk of falls, reduced independence in activities of daily living, and a decline in overall quality of life. Furthermore, frailty contributes to higher rates of hospitalization, increased healthcare utilization, and greater economic burden. Despite its clinical significance, the underlying biological and functional mechanisms contributing to frailty in MS remain insufficiently understood.
Recent attention has been directed toward irisin, a myokine released from skeletal muscle in response to physical activity and exercise. Irisin is known to play a role in energy homeostasis, glucose metabolism, and the browning of white adipose tissue, thereby contributing to improved metabolic efficiency. Additionally, irisin has been linked to muscle strength, physical performance, and the prevention of sarcopenia. Lower circulating levels of irisin have been associated with decreased muscle function, reduced exercise capacity, and increased frailty in various populations. However, the relationship between irisin levels, frailty status, and physical fitness in individuals with MS has not yet been adequately investigated.
Therefore, the primary aim of this study is to compare frailty status, physical fitness parameters, and circulating irisin levels between patients diagnosed with MS and age- and sex-matched healthy individuals between the ages of 18 and 65 years. A secondary objective is to explore the potential associations between these variables within the MS population.
Participants will undergo a comprehensive evaluation protocol before rehabilitation protocol starts and without any intervention to the patients., including validated clinical and functional assessments. Functional independence will be measured using the Functional Independence Measure (FIM), while frailty status will be assessed through the Frailty Index. Balance performance will be evaluated using the Berg Balance Scale, and aerobic capacity and endurance will be measured with the 6-Minute Walk Test. In addition, upper extremity muscle strength will be assessed via handgrip dynamometry. To complement these functional assessments, venous blood samples will be collected from all participants, and circulating irisin levels will be quantified using the enzyme-linked immunosorbent assay (ELISA) method.
Statistical analyses will be conducted to determine differences between the MS and healthy control groups in terms of frailty, physical fitness parameters, and irisin levels. Furthermore, correlation analyses will be performed to investigate potential relationships among frailty status, functional performance measures, and circulating irisin concentrations.
It is anticipated that the findings of this study will provide valuable insights into the interplay between frailty, physical fitness, and biochemical markers in individuals with MS. A better understanding of these relationships may help clarify the mechanisms underlying frailty in this population and support the development of more targeted, multidisciplinary rehabilitation and disease management strategies aimed at improving functional outcomes and overall quality of life.
- Conditions
- MULTIPL SCLEROSİS
- Keywords
- biomarker, physical fitness, multiple sclerosis, muscle weakness, functional performance
- Medical subject headings
- Multiple Sclerosis, Muscle Weakness
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 |
|---|---|---|
| multple sclerosis | Patients aged 18-65 diagnosed with Multiple Sclerosis (diagnosed with MRI, lumbar puncture, etc) who applied to the Başkent University Alanya Hospital Center Physical Medicine and Rehabilitation outpatient clinic between April 1, 2026, and May 30 2026 | |
| control group | healthy volunteers aged 18-65 years with similar demographic characteristics (age, gender, etc.) like multiple sclerosis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
fraility index
The Frailty Index (FI) is a quantitative measure of frailty based on the concept of "accumulated deficits," first developed by researchers including Kenneth Rockwood and Arnold Mitnitski. It reflects the proportion of health deficits an individual has out of a defined total number assessed. Deficits can include symptoms, diseases, disabilities, cognitive impairments, abnormal laboratory values, or functional limitations, typically numbering 30-70 variables. Each deficit is scored as 0 (absent) or 1 (present), though intermediate values (e.g., 0.5) may be used for partial impairment. The Frailty Index is calculated by dividing the number of deficits present by the total number measured (e.g., 10 deficits out of 40 variables = FI of 0.25). Scores range from 0 to 1, with higher values indicating greater frailty; commonly, <0.10 suggests robustness, 0.10-0.24 mild frailty, 0.25-0.39 moderate frailty, and ≥0.40 severe frailty.
Measured: 3 months
Secondary outcomes (4)
irisin level
Irisin is a 112-amino acid polypeptide hormone first identified in 2012. It is released from skeletal muscle during exercise and plays a role in energy metabolism by promoting the browning of white adipose tissue, thereby increasing energy expenditure. Exercise-induced muscle contraction elevates intracellular calcium (Ca²⁺) levels, which stimulates AMP-activated protein kinase (AMPK) phosphorylation. This activation triggers irisin production through the AMPK-PGC-1α-FNDC5 signaling pathway. Circulating irisin levels have therefore been proposed as a biomarker of muscle mass and physical performance. Reduced irisin concentrations have been observed in individuals with sarcopenia and pre-sarcopenia compared to non-sarcopenic controls.
Measured: 3 months
Functional Independence Measure (FIM)
The Functional Independence Measure (FIM) is a standardized assessment tool developed in the 1980s by the Uniform Data System for Medical Rehabilitation to evaluate a patient's level of disability and functional independence, particularly in rehabilitation settings. It assesses 18 items across six domains: self-care (eating, grooming, bathing, dressing, toileting), sphincter control (bladder and bowel management), transfers (bed, chair, toilet, tub/shower), locomotion (walking or wheelchair use and stairs), communication (comprehension and expression), and social cognition (social interaction, problem-solving, memory). Each item is scored on a 7-point scale, where 7 indicates complete independence, 6 modified independence (use of device or extra time), 5 supervision or setup, 4 minimal assistance (patient performs 75% or more of the task), 3 moderate assistance (50-74%), 2 maximal assistance (25-49%), and 1 total assistance (less than 25% effort or requires two helpers). The total FIM
Measured: 3 months
6-Minute Walk Test:
Measures functional walking capacity and endurance. It is a simple, practical, and widely used functional exercise test that measures the distance an individual can walk on a flat, hard surface in six minutes. It is designed to assess submaximal aerobic capacity and endurance, reflecting daily activity performance rather than maximal exercise capacity. The test is commonly used in patients with cardiovascular, pulmonary, or musculoskeletal conditions, as well as in older adults and those undergoing rehabilitation. Standardized protocols recommend a 30-meter corridor, with patients instructed to walk as far as possible in six minutes at a self-paced speed, allowing rests if needed. The primary outcome is the total distance walked (6-minute walk distance, 6MWD), often compared to reference values based on age, sex, height, and weight.
Measured: 3 months
• BERG Balance Scale:
The Berg Balance Scale (BBS) is a widely used clinical tool designed to assess balance and risk of falls in adults, especially older adults and individuals with neurological or musculoskeletal impairments. Developed by Katherine Berg in 1989, the BBS evaluates a person's ability to maintain balance during static and dynamic tasks through 14 functional activities, including sitting to standing, standing unsupported, reaching forward, turning, retrieving objects from the floor, and standing on one foot. Each task is scored on a 5-point scale (0-4), where 0 indicates the lowest level of function and 4 reflects independent and safe performance. The maximum total score is 56, with higher scores indicating better balance. Commonly used cutoffs suggest that a score below 45 may indicate increased fall risk, while lower scores correlate with greater functional impairment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for MULTIPL SCLEROSİSStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 782 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Kuculmez, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521982
- Sponsor's protocol ID
- KA25/237
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al Worikat N, Molaei F, Zanotto A, Tabatabaei A, Lynch SG, Troen BR, Sosnoff JJ, Zanotto T. Frailty in multiple sclerosis: A scoping review. Mult Scler Relat Disord. 2024 Dec;92:106157. doi: 10.1016/j.msard.2024.106157. Epub 2024 Nov 5.
PubMed 39520740Zanotto T, Galperin I, Mirelman A, Chen L, Regev K, Karni A, Schmitz-Hubsch T, Paul F, Lynch SG, Akinwuntan AE, Devos H, Hausdorff JM, Sosnoff JJ. Association Between Frailty and Free-Living Walking Performance in People With Multiple Sclerosis. Phys Ther. 2023 May 4;103(5):pzad032. doi: 10.1093/ptj/pzad032.
PubMed 37249534Liu S, Cui F, Ning K, Wang Z, Fu P, Wang D, Xu H. Role of irisin in physiology and pathology. Front Endocrinol (Lausanne). 2022 Sep 26;13:962968. doi: 10.3389/fendo.2022.962968. eCollection 2022.
PubMed 36225200Dodds TA, Martin DP, Stolov WC, Deyo RA. A validation of the functional independence measurement and its performance among rehabilitation inpatients. Arch Phys Med Rehabil. 1993 May;74(5):531-6. doi: 10.1016/0003-9993(93)90119-u.
PubMed 8489365Idiman E, Uzunel F, Ozakbas S, Yozbatiran N, Oguz M, Callioglu B, Gokce N, Bahar Z. Cross-cultural adaptation and validation of multiple sclerosis quality of life questionnaire (MSQOL-54) in a Turkish multiple sclerosis sample. J Neurol Sci. 2006 Jan 15;240(1-2):77-80. doi: 10.1016/j.jns.2005.09.009. Epub 2005 Nov 8.
PubMed 16277993Savci S, Inal-Ince D, Arikan H, Guclu-Gunduz A, Cetisli-Korkmaz N, Armutlu K, Karabudak R. Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis. Disabil Rehabil. 2005 Nov 30;27(22):1365-71. doi: 10.1080/09638280500164479.
PubMed 16372431Sahin F, Yilmaz F, Ozmaden A, Kotevolu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Berg Balance Scale. J Geriatr Phys Ther. 2008;31(1):32-7. doi: 10.1519/00139143-200831010-00006.
PubMed 18489806Zanotto T, Rice LA, Sosnoff JJ. Frailty among people with multiple sclerosis who are wheelchair users. PLoS One. 2022 Jul 15;17(7):e0271688. doi: 10.1371/journal.pone.0271688. eCollection 2022.
PubMed 35839220Searle SD, Mitnitski A, Gahbauer EA, Gill TM, Rockwood K. A standard procedure for creating a frailty index. BMC Geriatr. 2008 Sep 30;8:24. doi: 10.1186/1471-2318-8-24.
PubMed 18826625
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Frailty, Physical Fitness Parameters, and Irisin Levels Between Patients With Multiple Sclerosis and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07521982
- Acronym / sponsor ID
- KA25/237
- Conditions
- MULTIPL SCLEROSİS
- Keywords
- biomarker, physical fitness, multiple sclerosis, muscle weakness, functional performance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 782 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Apr 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.
Multiple Sclerosis (MS) is a chronic immune-mediated and neurodegenerative disease of the central nervous system that often affects young adults and is more common in women. In addition to neurological disability, individuals with MS frequently experience frailty, a condition characterized by reduced physiological reserve, weakness, fatigue, decreased physical activity, and increased vulnerability to stressors. Frailty in MS is associated with poorer mobility, higher fall risk, reduced quality of life, and increased healthcare utilization. Irisin, a hormone released from skeletal muscles during exercise, is linked to energy metabolism and muscle function, and lower levels have been associated with reduced physical performance and sarcopenia. However, the relationship between frailty, physical fitness, and irisin levels in individuals with MS has not been sufficiently explored.
This study aims to compare frailty status, physical fitness parameters, and circulating irisin levels between patients with MS and healthy volunteers aged 18-65 years. Participants will undergo assessments including the Functional Independence Measure, Frailty Index, Berg Balance Scale, 6-Minute Walk Test, and handgrip strength measurement. Blood samples will also be collected to determine irisin levels using the ELISA method. Statistical analyses will evaluate differences between groups and correlations among frailty, functional performance, and irisin levels. The findings are expected to improve understanding of frailty mechanisms in MS and contribute to developing targeted rehabilitation and management strategies.
Detailed description
Multiple Sclerosis (MS) is a chronic, immune-mediated, and neurodegenerative disorder of the central nervous system, characterized by inflammation, demyelination, and progressive axonal damage. It predominantly affects young adults and has a higher prevalence among women. The disease course is highly variable, often leading to a wide range of physical, cognitive, and psychosocial impairments that can significantly impact daily functioning and long-term quality of life.
In addition to neurological disability, individuals with MS frequently experience frailty, a multidimensional clinical syndrome marked by diminished physiological reserve and reduced resilience to internal and external stressors. Frailty is typically characterized by symptoms such as generalized weakness, persistent fatigue, decreased physical activity, slowed motor performance, and increased vulnerability to adverse health outcomes. In the context of MS, frailty represents an important but underrecognized condition that may exacerbate disease burden and accelerate functional decline.
The presence of frailty in individuals with MS has been associated with poorer mobility, impaired balance, increased risk of falls, reduced independence in activities of daily living, and a decline in overall quality of life. Furthermore, frailty contributes to higher rates of hospitalization, increased healthcare utilization, and greater economic burden. Despite its clinical significance, the underlying biological and functional mechanisms contributing to frailty in MS remain insufficiently understood.
Recent attention has been directed toward irisin, a myokine released from skeletal muscle in response to physical activity and exercise. Irisin is known to play a role in energy homeostasis, glucose metabolism, and the browning of white adipose tissue, thereby contributing to improved metabolic efficiency. Additionally, irisin has been linked to muscle strength, physical performance, and the prevention of sarcopenia. Lower circulating levels of irisin have been associated with decreased muscle function, reduced exercise capacity, and increased frailty in various populations. However, the relationship between irisin levels, frailty status, and physical fitness in individuals with MS has not yet been adequately investigated.
Therefore, the primary aim of this study is to compare frailty status, physical fitness parameters, and circulating irisin levels between patients diagnosed with MS and age- and sex-matched healthy individuals between the ages of 18 and 65 years. A secondary objective is to explore the potential associations between these variables within the MS population.
Participants will undergo a comprehensive evaluation protocol before rehabilitation protocol starts and without any intervention to the patients., including validated clinical and functional assessments. Functional independence will be measured using the Functional Independence Measure (FIM), while frailty status will be assessed through the Frailty Index. Balance performance will be evaluated using the Berg Balance Scale, and aerobic capacity and endurance will be measured with the 6-Minute Walk Test. In addition, upper extremity muscle strength will be assessed via handgrip dynamometry. To complement these functional assessments, venous blood samples will be collected from all participants, and circulating irisin levels will be quantified using the enzyme-linked immunosorbent assay (ELISA) method.
Statistical analyses will be conducted to determine differences between the MS and healthy control groups in terms of frailty, physical fitness parameters, and irisin levels. Furthermore, correlation analyses will be performed to investigate potential relationships among frailty status, functional performance measures, and circulating irisin concentrations.
It is anticipated that the findings of this study will provide valuable insights into the interplay between frailty, physical fitness, and biochemical markers in individuals with MS. A better understanding of these relationships may help clarify the mechanisms underlying frailty in this population and support the development of more targeted, multidisciplinary rehabilitation and disease management strategies aimed at improving functional outcomes and overall quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multple sclerosis | – | –Patients aged 18-65 diagnosed with Multiple Sclerosis (diagnosed with MRI, lumbar puncture, etc) who applied to the Başkent University Alanya Hospital Center Physical Medicine and Rehabilitation outpatient clinic between April 1, 2026, and May 30 2026 |
| control group | – | –healthy volunteers aged 18-65 years with similar demographic characteristics (age, gender, etc.) like multiple sclerosis group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 diagnosed with MS who applied to the Başkent University Alanya Hospital Center Physical Medicine and Rehabilitation outpatient clinic between April 1, 2026, and May 30 2026, and healthy volunteers aged 18-65 years with similar demographic characteristics (age, gender, etc.) will be included.
Key inclusion criteria (4 listed)
- Patients aged 18-65 evaluated by neurology and diagnosed with definitive MS via objective methods (MRI, lumbar puncture, etc.).
- Healthy volunteers aged 18-65.
- Being literate in Turkish.
- Participants who provide a consent form to participate in the study.
Key exclusion criteria (6 listed)
- Being younger than 18 or older than 65.
- Presence of any concomitant neurological disease other than MS.
- Presence of an uncontrolled systemic disease at a level that would affect the evaluation.
- Presence of cognitive impairment or psychiatric illness at a level that would affect the evaluation.
- Having had an MS attack or received steroid treatment in the last month.
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
fraility index
Time frame: 3 months
The Frailty Index (FI) is a quantitative measure of frailty based on the concept of "accumulated deficits," first developed by researchers including Kenneth Rockwood and Arnold Mitnitski. It reflects the proportion of health deficits an individual has out of a defined total number assessed. Deficits can include symptoms, diseases, disabilities, cognitive impairments, abnormal laboratory values, or functional limitations, typically numbering 30-70 variables. Each deficit is scored as 0 (absent) or 1 (present), though intermediate values (e.g., 0.5) may be used for partial impairment. The Frailty Index is calculated by dividing the number of deficits present by the total number measured (e.g., 10 deficits out of 40 variables = FI of 0.25). Scores range from 0 to 1, with higher values indicating greater frailty; commonly, <0.10 suggests robustness, 0.10-0.24 mild frailty, 0.25-0.39 moderate frailty, and ≥0.40 severe frailty.
4 secondary outcomes
irisin level
Time frame: 3 months
Functional Independence Measure (FIM)
Time frame: 3 months
6-Minute Walk Test:
Time frame: 3 months
• BERG Balance Scale:
Time frame: 3 months
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 13 Apr 2026.
- Background: PubMed 39520740Al Worikat N, Molaei F, Zanotto A, Tabatabaei A, Lynch SG, Troen BR, Sosnoff JJ, Zanotto T. Frailty in multiple sclerosis: A scoping review. Mult Scler Relat Disord. 2024 Dec;92:106157. doi: 10.1016/j.msard.2024.106157. Epub 2024 Nov 5.
- Background: PubMed 37249534Zanotto T, Galperin I, Mirelman A, Chen L, Regev K, Karni A, Schmitz-Hubsch T, Paul F, Lynch SG, Akinwuntan AE, Devos H, Hausdorff JM, Sosnoff JJ. Association Between Frailty and Free-Living Walking Performance in People With Multiple Sclerosis. Phys Ther. 2023 May 4;103(5):pzad032. doi: 10.1093/ptj/pzad032.
- Background: PubMed 36225200Liu S, Cui F, Ning K, Wang Z, Fu P, Wang D, Xu H. Role of irisin in physiology and pathology. Front Endocrinol (Lausanne). 2022 Sep 26;13:962968. doi: 10.3389/fendo.2022.962968. eCollection 2022.
- Background: PubMed 8489365Dodds TA, Martin DP, Stolov WC, Deyo RA. A validation of the functional independence measurement and its performance among rehabilitation inpatients. Arch Phys Med Rehabil. 1993 May;74(5):531-6. doi: 10.1016/0003-9993(93)90119-u.
- Background: PubMed 16277993Idiman E, Uzunel F, Ozakbas S, Yozbatiran N, Oguz M, Callioglu B, Gokce N, Bahar Z. Cross-cultural adaptation and validation of multiple sclerosis quality of life questionnaire (MSQOL-54) in a Turkish multiple sclerosis sample. J Neurol Sci. 2006 Jan 15;240(1-2):77-80. doi: 10.1016/j.jns.2005.09.009. Epub 2005 Nov 8.
- Background: PubMed 16372431Savci S, Inal-Ince D, Arikan H, Guclu-Gunduz A, Cetisli-Korkmaz N, Armutlu K, Karabudak R. Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis. Disabil Rehabil. 2005 Nov 30;27(22):1365-71. doi: 10.1080/09638280500164479.
- Background: PubMed 18489806Sahin F, Yilmaz F, Ozmaden A, Kotevolu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Berg Balance Scale. J Geriatr Phys Ther. 2008;31(1):32-7. doi: 10.1519/00139143-200831010-00006.
- Background: PubMed 35839220Zanotto T, Rice LA, Sosnoff JJ. Frailty among people with multiple sclerosis who are wheelchair users. PLoS One. 2022 Jul 15;17(7):e0271688. doi: 10.1371/journal.pone.0271688. eCollection 2022.
- Background: PubMed 18826625Searle SD, Mitnitski A, Gahbauer EA, Gill TM, Rockwood K. A standard procedure for creating a frailty index. BMC Geriatr. 2008 Sep 30;8:24. doi: 10.1186/1471-2318-8-24.
- Individual participant dataSharing planned: No
Related trials for MULTIPL SCLEROSİS
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.
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 MULTIPL SCLEROSİS, run by Baskent 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 4 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 13 Apr 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 Hüseyin Tas, physiotherapist (+905340789769 ext. +905340789769, hsyntas07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fraility index (time frame: 3 months). 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 NCT07521982, which also lists 9 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 13 Apr 2026.