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

September 9, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Axial Spondylarthritis (axSpA)

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey (Türkiye)
- - Giresun, Turkey (Türkiye), 28200
    - Giresun University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 4 weeks
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.	Baseline and 4 weeks
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.	Baseline and 4 weeks
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.	Baseline and 4 weeks
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.	Baseline and 4 weeks
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.	Baseline and 4 weeks
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.	Baseline and 4 weeks
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).	Baseline and 4 weeks
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).	Baseline and 4 weeks
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.	Baseline and 4 weeks
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.	Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giresun University

Investigators

Study Director: Zerrin KASAP, Giresun University
Principal Investigator: Asude cevher ELMAS TELLİ, Giresun University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

September 9, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)