Comparison of Frailty, Physical Fitness Parameters, and Irisin Levels Between Patients With Multiple Sclerosis and Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 782
- 试验地点
- 1
- 主要终点
- fraility index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-65 evaluated by neurology and diagnosed with definitive MS via objective methods (MRI, lumbar puncture, etc.).
- •Healthy volunteers aged 18-
- •Being literate in Turkish.
- •Participants who provide a consent form to participate in the study.
排除标准
- •Being younger than 18 or older than
- •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.
研究组 & 干预措施
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
结局指标
主要结局
fraility index
时间窗: 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.
次要结局
- irisin level(3 months)
- Functional Independence Measure (FIM)(3 months)
- 6-Minute Walk Test:(3 months)
- • BERG Balance Scale:(3 months)
研究者
Ozlem Kuculmez
Assistant Professor
Baskent University