Association Between Peripheral Immune Biomarkers and Functional Performance in Multiple Sclerosis
ASSOCIATION BETWEEN PERIPHERAL IMMUNE BIOMARKERS AND FUNCTIONAL PERFORMANCE IN PATIENTS WITH MULTIPLE SCLEROSIS
The aim of this observational study is to investigate whether certain substances in the blood associated with the immune system are linked to the physical and mental abilities of individuals with multiple sclerosis. The study will examine the relationship of these substances with walking, hand coordination, cognitive skills, and functional loss resulting from the disease. Blood samples will be collected from participants, and simple tests assessing walking, hand coordination, and cognitive skills will be administered.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Van, Turkey (Türkiye), 65100
- Van Regional Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Adults with multiple sclerosis who underwent baseline assessment of functional performance and peripheral immune biomarkers.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_ONLY
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Multiple sclerosis participants
Participants with multiple sclerosis who were evaluated to examine the relationship between peripheral immune biomarkers and functional performance. |
Peripheral immune biomarkers, including tumor necrosis factor-alpha, interleukin-8 (IL-8/CXCL8), and adiponectin, were measured in serum samples collected at baseline. No therapeutic intervention was administered as part of this observational study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multiple Sclerosis Functional Composite (MSFC)
Time Frame: At baseline (study enrollment)
|
The Multiple Sclerosis Functional Composite (MSFC) is a standardized measure of functional performance in people with multiple sclerosis. It includes walking ability, hand coordination, and cognitive processing speed. |
At baseline (study enrollment)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAD-FR-43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data will not be shared with other researchers because the data contain potentially identifiable participant information and are subject to ethical and privacy considerations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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