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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Van, Türkei (türkiye), 65100
- Van Regional Training and Research Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Adults with multiple sclerosis who underwent baseline assessment of functional performance and peripheral immune biomarkers.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: CASE_ONLY
- Zeitperspektiven: CROSS_SECTIONAL
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Multiple Sclerosis Functional Composite (MSFC)
Zeitfenster: At baseline (study enrollment)
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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)
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KAD-FR-43
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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.
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