About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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
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.
• 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.
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