Changes in Serum Calprotectin and Their Clinical Correlates in Axial Spondyloarthritis Patients Undergoing Pulmonary Rehabilitation
9 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
30
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
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Giresun, Turquía (Türkiye), 28200
- Giresun University Faculty of Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in serum calprotectin levels before and after pulmonary rehabilitation.
Periodo de tiempo: Baseline and 4 weeks
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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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in C-reactive protein [CRP] before and after pulmonary rehabilitation.
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Baseline and 4 weeks
|
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Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Baseline and 4 weeks
|
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Change in St. George's Respiratory Questionnaire (SGRQ) Total Score
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
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Change in Nottingham Health Profile (NHP) Total Score
Periodo de tiempo: 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).
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Baseline and 4 weeks
|
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Change in Systemic Immune-Inflammation Index (SII)
Periodo de tiempo: 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
|
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Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Periodo de tiempo: Baseline and 4 weeks
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Calculated as the ratio of absolute neutrophil count to absolute lymphocyte count from baseline to 4 weeks post-pulmonary rehabilitation.
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Baseline and 4 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Zerrin KASAP, Giresun University
- Investigador principal: Asude cevher ELMAS TELLİ, Giresun University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de agosto de 2025
Finalización primaria (Actual)
31 de diciembre de 2025
Finalización del estudio (Actual)
31 de diciembre de 2025
Fechas de registro del estudio
Enviado por primera vez
2 de diciembre de 2025
Primero enviado que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Publicado por primera vez (Actual)
16 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Changes in Serum Calprotectin
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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