Association Between Peripheral Immune Biomarkers and Functional Performance in Multiple Sclerosis

This is an observational, cross-sectional study investigating the relationship between peripheral immune biomarkers and functional performance in patients with multiple sclerosis (MS). The study is designed to determine whether selected peripheral immune biomarkers are associated with functional performance and disability-related measures in individuals with MS.

Participants with a diagnosis of multiple sclerosis will be evaluated using clinical, demographic, functional, and laboratory measurements. The study includes 20 patients with multiple sclerosis. Data were collected between June 1, 2026 and July 30, 2026. All assessments were performed using baseline data, and no therapeutic or exercise intervention was administered as part of this study.

Peripheral immune biomarkers evaluated in the study include tumor necrosis factor-alpha (TNF-α), interleukin-8 (IL-8/CXCL8), and adiponectin. These biomarkers will be examined in relation to measures of functional performance.

Functional performance will be assessed using the Multiple Sclerosis Functional Composite (MSFC) and its components, including the Timed 25-Foot Walk test, the Nine-Hole Peg Test, and the Paced Auditory Serial Addition Test (PASAT). The results of the individual MSFC components will also be evaluated separately. Disability status will be assessed using the Expanded Disability Status Scale (EDSS).

Demographic and clinical characteristics, including age, sex, body mass index, and disease duration, will also be recorded. These characteristics will be considered when describing the study population and evaluating the relationship between immune biomarkers and functional performance.

The primary objective of the study is to investigate the association between peripheral immune biomarker levels and functional performance in patients with multiple sclerosis. The secondary objective is to examine the associations between individual immune biomarkers and the individual components of the MSFC, as well as disability status assessed by the EDSS.

The study uses an observational correlational design. Associations between continuous variables will be evaluated using appropriate correlation analyses based on the distribution and characteristics of the data. The study does not involve assignment to an intervention group, administration of an investigational treatment, or modification of participants' usual clinical care.

Inclusion criteria

• MS patients aged 19-45 who have been diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS), are not receiving steroid therapy, and have an Expanded Disability Status Scale (EDSS) score of 0.5-3.5.

Exclusion criteria

Those with a high level of physical activity; those experiencing an acute MS relapse or with a history of relapse within the last 3 months; those with orthopedic or systemic problems preventing participation in exercise; those with a known neuromuscular or immune disorder other than MS; those who started immunomodulatory therapy within the last 6 months; those with visual involvement or diplopia; those with severe lower-extremity spasticity (Modified Ashworth Scale score of 3 or 4); those with cardiopulmonary problems preventing participation in exercise.