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Changes in Serum Calprotectin and Their Clinical Correlates in Axial Spondyloarthritis Patients Undergoing Pulmonary Rehabilitation

9 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Studietype

Observationeel

Inschrijving (Werkelijk)

30

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Turkije (Türkiye)
      • Giresun, Turkije (Türkiye), 28200
        • Giresun University Faculty of Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in serum calprotectin levels before and after pulmonary rehabilitation.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in C-reactive protein [CRP] before and after pulmonary rehabilitation.
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Giresun University

Onderzoekers

  • Studie directeur: Zerrin KASAP, Giresun University
  • Hoofdonderzoeker: Asude cevher ELMAS TELLİ, Giresun University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 augustus 2025

Primaire voltooiing (Werkelijk)

31 december 2025

Studie voltooiing (Werkelijk)

31 december 2025

Studieregistratiedata

Eerst ingediend

2 december 2025

Eerst ingediend dat voldeed aan de QC-criteria

9 september 2026

Eerst geplaatst (Werkelijk)

16 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 september 2026

Laatste update ingediend die voldeed aan QC-criteria

9 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • Changes in Serum Calprotectin

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