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

NCT07821541 | Completed

• 1 other identifier: Changes in Serum Calprotectin
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Axial Spondylarthritis (axSpA)

Keywords

pulmonary rehabilitation; quality of life; serum calprotectin levels

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (11)

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

  Baseline and 4 weeks

• Change in Erythrocyte Sedimentation Rate (ESR)

  Baseline and 4 weeks

• Change in Systemic Inflammation Response Index (SIRI)

  Baseline and 4 weeks

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

  Baseline and 4 weeks

• Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score

  Baseline and 4 weeks

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun University Faculty of Medicine

Giresun, 28200, Turkey (Türkiye)

Location

Study Officials

• Zerrin KASAP

  Giresun University

  STUDY DIRECTOR

• Asude cevher ELMAS TELLİ

  Giresun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Resident Physician

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: September 16, 2026
• Study Start: August 2, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)