Changes in Serum Calprotectin and Their Clinical Correlates in Axial Spondyloarthritis Patients Undergoing Pulmonary Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in serum calprotectin levels before and after pulmonary rehabilitation.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in serum calprotectin levels before and after pulmonary rehabilitation.
时间窗: 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.
次要结局
- 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)
- Change in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)(Baseline and 4 weeks)
- Change in St. George's Respiratory Questionnaire (SGRQ) Total Score(Baseline and 4 weeks)
- Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)(Baseline and 4 weeks)
- Change in Nottingham Health Profile (NHP) Total Score(Baseline and 4 weeks)
- Change in Systemic Immune-Inflammation Index (SII)(Baseline and 4 weeks)
- Change in Neutrophil-to-Lymphocyte Ratio (NLR)(Baseline and 4 weeks)
研究者
Asude Cevher Elmas Telli
MD, Resident Physician
Giresun University