Axial Spondylarthritis (axSpA)NCT07821541
Changes in Serum Calprotectin and Their Clinical Correlates in Axial Spondyloarthritis Patients Undergoing Pulmonary Rehabilitation
An observational study of Axial Spondylarthritis (axSpA), run by Giresun University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Axial Spondylarthritis (axSpA)
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun University Faculty of Medicine
Giresun, 28200
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
Secondary outcomes (11)
Changes in C-reactive protein [CRP] before and after pulmonary rehabilitation.
Measured via standard blood serum analysis in milligrams per liter (mg/L) from baseline to 4 weeks post-pulmonary rehabilitation.
Measured: Baseline and 4 weeks
Change in Erythrocyte Sedimentation Rate (ESR)
Measured in millimeters per hour (mm/hr) from baseline to 4 weeks post-pulmonary rehabilitation.
Measured: Baseline and 4 weeks
Change in Systemic Inflammation Response Index (SIRI)
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.
Measured: Baseline and 4 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
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.
Measured: Baseline and 4 weeks
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
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.
Measured: Baseline and 4 weeks
Change in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)
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.
Measured: Baseline and 4 weeks
Change in St. George's Respiratory Questionnaire (SGRQ) Total Score
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.
Measured: Baseline and 4 weeks
Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
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).
Measured: Baseline and 4 weeks
Change in Nottingham Health Profile (NHP) Total Score
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).
Measured: Baseline and 4 weeks
Change in Systemic Immune-Inflammation Index (SII)
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.
Measured: Baseline and 4 weeks
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Calculated as the ratio of absolute neutrophil count to absolute lymphocyte count from baseline to 4 weeks post-pulmonary rehabilitation.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start2 Aug 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial Spondylarthritis (axSpA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asude Cevher Elmas Telli, Giresun University
- Investigators
- Zerrin KASAP, Study director, Giresun UniversityAsude cevher ELMAS TELLİ, Principal investigator, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821541
- Sponsor's protocol ID
- Changes in Serum Calprotectin
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Serum Calprotectin and Their Clinical Correlates in Axial Spondyloarthritis Patients Undergoing Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT07821541
- Acronym / sponsor ID
- Changes in Serum Calprotectin
- Conditions
- Axial Spondylarthritis (axSpA)
- Keywords
- pulmonary rehabilitation, quality of life, serum calprotectin levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
Changes in C-reactive protein [CRP] before and after pulmonary rehabilitation.
Time frame: Baseline and 4 weeks
Change in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline and 4 weeks
Change in Systemic Inflammation Response Index (SIRI)
Time frame: Baseline and 4 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Time frame: Baseline and 4 weeks
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Time frame: Baseline and 4 weeks
Change in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)
Time frame: Baseline and 4 weeks
Change in St. George's Respiratory Questionnaire (SGRQ) Total Score
Time frame: Baseline and 4 weeks
Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Time frame: Baseline and 4 weeks
Change in Nottingham Health Profile (NHP) Total Score
Time frame: Baseline and 4 weeks
Change in Systemic Immune-Inflammation Index (SII)
Time frame: Baseline and 4 weeks
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: Baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zerrin KASAP study director
Giresun University
Asude cevher ELMAS TELLİ principal investigator
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondylarthritis (axSpA), run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum calprotectin levels before and after pulmonary rehabilitation. (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.