Comparison of Frailty, Physical Fitness Parameters, and Irisin Levels Between Patients With Multiple Sclerosis and Healthy Volunteers

NCT07521982 | Not Yet Recruiting

• 1 other identifier: KA25/237
• Study Type: observational
• Target: 782
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

MULTIPL SCLEROSİS

Keywords

biomarker; physical fitness; multiple sclerosis; muscle weakness; functional performance

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (4)

• irisin level

  3 months

• Functional Independence Measure (FIM)

  3 months

• 6-Minute Walk Test:

  3 months

• • BERG Balance Scale:

  3 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Alanya Hospital

Antalya, Alanya, 07400, Turkey (Türkiye)

Location

Related Publications (9)

• Molaei F, Zanotto A, Tabatabaei A, Lynch SG, Troen BR, Sosnoff JJ, et al. Frailty in multiple sclerosis: A scoping review. Multiple Sclerosis and Related Disorders. 2024:106157.

  BACKGROUND

• Zanotto T, Galperin I, Mirelman A, Chen L, Regev K, Karni A, et al. Association between frailty and free-living walking performance in people with multiple sclerosis. Physical therapy. 2023;103(5):pzad032.

  BACKGROUND

• Liu 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.

  BACKGROUND

• A Validation of the Functional Independence Measure (FIM) and Its Performance Among Rehabilitation Patients. Archives of Physical Medicine and Rehabilitation 1993; 74 : 531-536

  BACKGROUND

• Idiman, Egemen, et al. "Cross-cultural adaptation and validation of multiple sclerosis quality of life questionnaire (MSQOL-54) in a Turkish multiple sclerosis sample." Journal of the neurological sciences 240.1-2 (2006): 77-80.

  BACKGROUND

• Savci, Sema, et al. "Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis." Disability and rehabilitation 27.22 (2005): 1365-1371.

  BACKGROUND

• Sahin, Fusun, et al. "Reliability and validity of the Turkish version of the Berg Balance Scale." Journal of geriatric physical therapy 31.1 (2008): 32-37.

  BACKGROUND

• Zanotto, T., Rice, L. A., & Sosnoff, J. J. (2022). Frailty among people with multiple sclerosis who are wheelchair users. PloSone, 17(7), e0271688.

  BACKGROUND

• Searle 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. PMID: 18826625; PMCID: PMC2573877.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples will be taken from all participants at 10:00 AM during the evaluation to measure irisin levels using the ELISA method.

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Weakness

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Hüseyin Tas, physiotherapist

CONTACT

+905340789769; hsyntas07@gmail.com

Ozlem Kuculmez, Asist. prof. dr.

CONTACT

+90555620521; akanozlem07@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)