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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Van, Turecko (Türkiye), 65100
- Van Regional Training and Research Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Adults with multiple sclerosis who underwent baseline assessment of functional performance and peripheral immune biomarkers.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: CASE_ONLY
- Časové perspektivy: CROSS_SECTIONAL
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Multiple Sclerosis Functional Composite (MSFC)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- KAD-FR-43
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
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