Changes in Serum Calprotectin and Their Clinical Correlates in Axial Spondyloarthritis Patients Undergoing Pulmonary Rehabilitation
9. září 2026 aktualizováno: Asude Cevher Elmas Telli, Giresun University
Our study aims to investigate changes in serum calprotectin levels in patients with axial spondyloarthritis enrolled in a pulmonary rehabilitation programme and to examine the relationship between serum calprotectin levels and NLR (neutrophil-lymphocyte ratio), PLR (platelet-lymphocyte ratio), SIRI (systemic inflammation response index), SII (systemic immune-inflammation index) values, pulmonary function tests, disease activity scores, and quality of life.
It will be conducted between 2 April 2025 and 1 April 2026.
Patients diagnosed with axial SpA who were enrolled in the pulmonary rehabilitation programme at the Cardiopulmonary Rehabilitation Unit of the Department of Physical Medicine and Rehabilitation at Giresun University Training and Research Hospital between 21 August 2025 - 24 February 2026, patients diagnosed with axial SpA who are enrolled in the pulmonary rehabilitation programme will be evaluated according to inclusion and exclusion criteria, and 30 suitable patients will be included in the study.
The following data will be recorded for these patients: age, gender, occupation, duration of diagnosis, medications used, presence of additional diseases, anthropometric measurements (chest expansion test, occipital wall, tragus wall, finger span), BMI, and history of smoking and alcohol consumption.
For patient follow-up, the results of routine haematological tests, acute phase reactants, and spirometry examinations performed before and after the rehabilitation programme will be recorded.
Data obtained from haematological test results will be used to calculate NLR, PLR, SIRI, and SII values.
Additionally, serum calprotectin levels will be measured from the blood sample taken for CRP.
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP), Maastricht Ankylosing Spondylitis Enthesitis Score (MASES), the Nottingham Health Profile (NHP), the Health Assessment Questionnaire (HAQ), the St George's Quality of Life Questionnaire (SGRQ), the Modified Borg Scale, and the 6-Minute Walk Test will be evaluated.
The outcome measures recorded at the start of treatment will be repeated after a four-week rehabilitation programme.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Pozorovací
Zápis (Aktuální)
30
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
-
Giresun, Turecko (Türkiye), 28200
- Giresun University Faculty of Medicine
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
A total of 30 voluntary patients aged between 25 and 65 years, diagnosed with axial spondyloarthritis according to the ASAS classification criteria, and enrolled in a pulmonary rehabilitation program at the Cardiopulmonary Rehabilitation Unit of the Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Giresun University, between April 2025 and April 2025, were included in the study.
Popis
Inclusion Criteria:
- Classification as axial spondyloarthritis according to the 2009 ASAS (Assessment of SpondyloArthritis International Society) criteria
- Age between 25 and 65 years
- Both male and female patients
- Ability to perform pulmonary function tests (PFTs) with full cooperation
Exclusion Criteria:
- Change in antirheumatic medication or dosage within the last 3 months
- Engagement in regular physical activity within the last 3 months
- History of unstable angina pectoris, cardiac arrhythmias, or myocardial infarction within the last 3 months
- Presence of any orthopedic, neurological, or mental disorder that could affect exercise performance
- History of pulmonary disease (asthma, COPD, atelectasis, etc.)
- Active malignancy and/or history of malignancy within the last 5 years
- History of syncope or exercise-induced arrhythmia
- Current pregnancy or planning pregnancy in the near future
- History of major surgery within the last 6 months
- Use of assistive devices for ambulation or presence of orthopedic joint prosthesis
- Patients with total spinal ankylosis
- Presence of a known additional rheumatologic disease
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in serum calprotectin levels before and after pulmonary rehabilitation.
Časové okno: Baseline and 4 weeks
|
The primary objective of this study was to evaluate the changes in serum calprotectin levels in patients with axial spondyloarthritis (axSpA) enrolled in a pulmonary rehabilitation program.
|
Baseline and 4 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changes in C-reactive protein [CRP] before and after pulmonary rehabilitation.
Časové okno: Baseline and 4 weeks
|
Measured via standard blood serum analysis in milligrams per liter (mg/L) from baseline to 4 weeks post-pulmonary rehabilitation.
|
Baseline and 4 weeks
|
|
Change in Erythrocyte Sedimentation Rate (ESR)
Časové okno: Baseline and 4 weeks
|
Measured in millimeters per hour (mm/hr) from baseline to 4 weeks post-pulmonary rehabilitation.
|
Baseline and 4 weeks
|
|
Change in Systemic Inflammation Response Index (SIRI)
Časové okno: Baseline and 4 weeks
|
Calculated from peripheral blood counts using the formula: SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count.
Assessed as a unitless ratio to evaluate systemic inflammatory status from baseline to 4 weeks post-pulmonary rehabilitation.
|
Baseline and 4 weeks
|
|
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Časové okno: Baseline and 4 weeks
|
Assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
Total score ranges from 0 to 10, where 0 indicates no disease activity and 10 indicates severe disease activity.
Higher scores represent worse outcomes.
|
Baseline and 4 weeks
|
|
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Časové okno: Baseline and 4 weeks
|
Assessed using the Bath Ankylosing Spondylitis Functional Index (BASFI) to evaluate functional limitations.
The BASFI consists of 10 items assessing daily physical activities.
Total score ranges from 0 to 10, where 0 represents easy/no functional impairment and 10 represents impossible/severe functional impairment.
Higher scores indicate worse functional limitations.
|
Baseline and 4 weeks
|
|
Change in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)
Časové okno: Baseline and 4 weeks
|
Assessed using the Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP), a composite index combining patient-reported assessments and serum C-reactive protein (CRP) levels.
Scores are categorized as: < 1.3 indicates inactive disease, 1.3 to 2.0 indicates moderate disease activity, 2.1 to 3.5 indicates high disease activity, and > 3.5 indicates very high disease activity.
Higher scores represent worse disease activity.
|
Baseline and 4 weeks
|
|
Change in St. George's Respiratory Questionnaire (SGRQ) Total Score
Časové okno: Baseline and 4 weeks
|
Assessed using the St. George's Respiratory Questionnaire (SGRQ) to measure health-related quality of life.
The questionnaire consists of 50 items across three domains: symptoms, activity, and impacts.
Total scores range from 0 to 100, where 0 indicates no impairment and 100 indicates maximum impairment.
Higher scores indicate worse health status and greater limitation.
|
Baseline and 4 weeks
|
|
Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Časové okno: Baseline and 4 weeks
|
Assessed using the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) to evaluate enthesitis across 13 anatomical locations bilaterally and at the 5th lumbar spinous process.
Tenderness is scored dichotomously (0 = absent, 1 = present).
Total score ranges from 0 to 13.
Higher scores indicate worse outcomes (more tender enthesis sites and greater disease activity).
|
Baseline and 4 weeks
|
|
Change in Nottingham Health Profile (NHP) Total Score
Časové okno: Baseline and 4 weeks
|
Assessed using the Nottingham Health Profile (NHP) to evaluate perceived emotional, social, and physical health problems across 38 items.
Each subscale score and the combined total score range from 0 to 100.
Higher scores indicate worse outcomes (greater perceived health problems and poorer quality of life).
|
Baseline and 4 weeks
|
|
Change in Systemic Immune-Inflammation Index (SII)
Časové okno: Baseline and 4 weeks
|
Calculated from peripheral blood counts using the formula: SII = (Platelet count × Neutrophil count) / Lymphocyte count.
Assessed as a unitless ratio from baseline to 4 weeks post-pulmonary rehabilitation.
|
Baseline and 4 weeks
|
|
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Časové okno: Baseline and 4 weeks
|
Calculated as the ratio of absolute neutrophil count to absolute lymphocyte count from baseline to 4 weeks post-pulmonary rehabilitation.
|
Baseline and 4 weeks
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Zerrin KASAP, Giresun University
- Vrchní vyšetřovatel: Asude cevher ELMAS TELLİ, Giresun University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
2. srpna 2025
Primární dokončení (Aktuální)
31. prosince 2025
Dokončení studie (Aktuální)
31. prosince 2025
Termíny zápisu do studia
První předloženo
2. prosince 2025
První předloženo, které splnilo kritéria kontroly kvality
9. září 2026
První zveřejněno (Aktuální)
16. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
16. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. září 2026
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- Changes in Serum Calprotectin
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .