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Completed

NCT Number: NCT07821541

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

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.

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Key information

Conditions

Axial Spondylarthritis (axSpA)

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Giresun University Faculty of Medicine

Giresun, 28200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in serum calprotectin levels before and after pulmonary rehabilitation.

    Time frame: 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.

Secondary outcomes

  1. Changes in C-reactive protein [CRP] before and after pulmonary rehabilitation.

    Time frame: Baseline and 4 weeks

    Measured via standard blood serum analysis in milligrams per liter (mg/L) from baseline to 4 weeks post-pulmonary rehabilitation.

  2. Change in Erythrocyte Sedimentation Rate (ESR)

    Time frame: Baseline and 4 weeks

    Measured in millimeters per hour (mm/hr) from baseline to 4 weeks post-pulmonary rehabilitation.

  3. Change in Systemic Inflammation Response Index (SIRI)

    Time frame: 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.

  4. Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score

    Time frame: 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.

  5. Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score

    Time frame: 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.

  6. Change in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)

    Time frame: 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.

  7. Change in St. George's Respiratory Questionnaire (SGRQ) Total Score

    Time frame: 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.

  8. Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

    Time frame: 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).

  9. Change in Nottingham Health Profile (NHP) Total Score

    Time frame: 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).

  10. Change in Systemic Immune-Inflammation Index (SII)

    Time frame: 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.

  11. Change in Neutrophil-to-Lymphocyte Ratio (NLR)

    Time frame: Baseline and 4 weeks

    Calculated as the ratio of absolute neutrophil count to absolute lymphocyte count from baseline to 4 weeks post-pulmonary rehabilitation.

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Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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