Changes in Serum Calprotectin and Their Clinical Correlates in Axial Spondyloarthritis Patients Undergoing Pulmonary Rehabilitation
9 de setembro de 2026 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
30
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
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Giresun, Turquia (Türkiye), 28200
- Giresun University Faculty of Medicine
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in serum calprotectin levels before and after pulmonary rehabilitation.
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in C-reactive protein [CRP] before and after pulmonary rehabilitation.
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
|
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Change in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
|
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Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Prazo: 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.
|
Baseline and 4 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Zerrin KASAP, Giresun University
- Investigador principal: Asude cevher ELMAS TELLİ, Giresun University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de agosto de 2025
Conclusão Primária (Real)
31 de dezembro de 2025
Conclusão do estudo (Real)
31 de dezembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
2 de dezembro de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de setembro de 2026
Primeira postagem (Real)
16 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Changes in Serum Calprotectin
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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