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临床试验/NCT07515131
NCT07515131已完成不适用

Chest Expansion, Pulmonary Function, and Dynamic Inspiratory Muscle Strength (S-index) in Patients With Radiographic Axial Spondyloarthritis

Gazi University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Inspiratory muscle strength assessed by S-index

研究概览

简要总结

Radiographic axial spondyloarthritis (r-axSpA) is a chronic inflammatory disease that may lead to reduced chest expansion and impaired respiratory function due to thoracic involvement. While inspiratory muscle strength is commonly assessed using maximum inspiratory pressure (MIP), the S-index is a novel parameter reflecting dynamic inspiratory muscle strength and has not yet been investigated in this population.

This study aims to compare chest expansion, spirometric parameters, and S-index values between individuals with r-axSpA and healthy controls. Additionally, the relationships between these parameters and clinical indices (BASDAI, BASFI, and BASMI) will be evaluated in patients with r-axSpA. The study also aims to explore the potential role of the S-index in the assessment of pulmonary function in this patient group.

详细描述

Radiographic axial spondyloarthritis (r-axSpA) is a systemic, chronic inflammatory rheumatic disease strongly associated with HLA-B27, primarily affecting the sacroiliac joints and the axial skeleton. Its prevalence in the general population ranges between approximately 0.1% and 1.4%. In patients with r-axSpA, involvement of the costovertebral and costosternal joints, as well as the entheses in the thoracic region, may lead to progressive ankylosis over time. This process results in reduced thoracic mobility, decreased chest expansion in the early stages, and a predominantly restrictive pattern of respiratory dysfunction.

Previous studies have investigated the relationships between chest expansion, aerobic capacity, and spirometric parameters with disease activity, functional status, and spinal mobility, as assessed by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and Bath Ankylosing Spondylitis Metrology Index (BASMI), in individuals with r-axSpA.

Maximum inspiratory pressure (MIP) is widely used for the static assessment of inspiratory muscle strength and has been evaluated in conjunction with chest expansion and spirometric parameters in several studies. In contrast, the S-index is a relatively novel parameter that reflects inspiratory muscle strength dynamically and has not yet been investigated in patients with r-axSpA. Although previous studies have demonstrated moderate to strong correlations between S-index and MIP, these measures represent different physiological aspects of respiratory muscle function and therefore do not yield identical results.

The present study aims to compare chest expansion, spirometric parameters, and S-index values between individuals with r-axSpA and healthy controls. In addition, within the r-axSpA group, the relationships between these parameters and clinical indices (BASDAI, BASFI, and BASMI) will be examined.

Furthermore, the discriminative ability of chest expansion, spirometric parameters, and the S-index in distinguishing individuals with r-axSpA from healthy controls will be evaluated. As a distinctive aspect of this study, S-index values will be analyzed both in comparison between groups and in relation to spirometric parameters, chest expansion, and clinical indices in patients with r-axSpA.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willingness to participate in the study and provide informed consent
  • Age ≥18 years
  • Absence of any known chronic disease (for the healthy control group)
  • Diagnosis of radiographic axial spondyloarthritis according to the Assessment of SpondyloArthritis international Society (ASAS) criteria and absence of any additional chronic disease (for the r-axSpA group)

排除标准

  • Presence of known cardiopulmonary disease
  • Presence of any rheumatologic disease other than radiographic axial spondyloarthritis (r-axSpA)
  • Inability to cooperate with testing procedures
  • Presence of chest wall or spinal deformities that may restrict lung capacity (e.g., pectus carinatum, pectus excavatum, scoliosis)
  • Professional athletes

研究组 & 干预措施

Healthy Control Group

Healthy individuals without a diagnosis of axial spondyloarthritis. Participants will undergo assessment of chest expansion, spirometric parameters, and inspiratory muscle strength using the S-index.

Radiographic Axial Spondyloarthritis (r-axSpA) Group

Individuals diagnosed with radiographic axial spondyloarthritis according to the Assessment of SpondyloArthritis international Society (ASAS) criteria, who were followed at the Department of Physical Medicine and Rehabilitation at Gazi University. Participants underwent standardized assessment of chest expansion, spirometric parameters, inspiratory muscle strength using the S-index, and clinical indices including BASDAI, BASFI, and BASMI

结局指标

主要结局

Inspiratory muscle strength assessed by S-index

时间窗: Baseline

S-index was measured using the PowerBreathe K5 device (PowerBreathe International Ltd., UK). The test assesses inspiratory muscle strength based on flow and pressure during dynamic inspiration from residual volume to total lung capacity. Measurements were performed under standardized conditions (same device, operator, afternoon hours, 20-25°C). Participants were seated upright with a nasal clip and instructed to perform maximal and rapid inspiratory efforts against resistance after normal expiration. Eight maneuvers were performed in 2-3 sets with ≥30-second rest intervals. The test was considered valid if the difference between the highest three values was \<10%, and the highest value was used for analysis.

次要结局

  • Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline)
  • Pulmonary function parameters (FVC, FEV1, FEV1/FVC, PEF)(Baseline)
  • Chest expansion(Baseline)
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI)(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse BOZDAS

Research Assistant, Physical Medicine and Rehabilitation, Principal Investigator, M.D.

Gazi University

研究点 (1)

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