Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

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

9 сентября 2026 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Осевой спондилоартрит (axSpA)

Тип исследования

Наблюдательный

Регистрация (Действительный)

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Турция (Туркие)
- - Giresun, Турция (Туркие), 28200
    - Giresun University Faculty of Medicine

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

Взрослый
Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Change in serum calprotectin levels before and after pulmonary rehabilitation. Временное ограничение: 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

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Changes in C-reactive protein [CRP] before and after pulmonary rehabilitation. Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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) Временное ограничение: 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 Временное ограничение: 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) Временное ограничение: 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 Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Giresun University

Следователи

Директор по исследованиям: Zerrin KASAP, Giresun University
Главный следователь: Asude cevher ELMAS TELLİ, Giresun University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

2 августа 2025 г.

Первичное завершение (Действительный)

31 декабря 2025 г.

Завершение исследования (Действительный)

31 декабря 2025 г.

Даты регистрации исследования

Первый отправленный

2 декабря 2025 г.

Впервые представлено, что соответствует критериям контроля качества

9 сентября 2026 г.

Первый опубликованный (Действительный)

16 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)