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临床试验/NCT07373704
NCT07373704尚未招募不适用

Optimal Cut-off Points of Respiratory Muscle Strength and Endurance to Discriminate Disability Status in Multiple Sclerosis

Selcuk University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Respiratory Muscle Strength (Maximal Inspiratory and Expiratory Pressures)

研究概览

简要总结

Multiple sclerosis (MS) is a chronic and progressive autoimmune disease of the central nervous system characterized by inflammation, demyelination, and axonal degeneration. Depending on lesion localization and disease severity, individuals with MS may develop a wide range of neurological manifestations affecting motor and sensory functions.

Current evidence indicates that pulmonary function impairments may occur in individuals with MS even in the absence of overt respiratory symptoms. Compared with healthy individuals, people with MS have been reported to exhibit significantly reduced values in several respiratory parameters, particularly respiratory muscle strength. Moreover, these reductions appear to become more pronounced in parallel with increasing Expanded Disability Status Scale (EDSS) scores, regardless of disease duration. Indeed, previous studies have demonstrated that even individuals with MS who have mild disability levels (EDSS 0-4.5) experience significant declines in respiratory muscle strength, pulmonary function, and functional exercise capacity compared with healthy controls.

These findings suggest that the respiratory system may be affected not only in the advanced stages of MS but also during the early phases of the disease, with functional impairments emerging before clinically evident respiratory complaints arise. Despite this, the existing literature lacks studies that define clear, clinically applicable cut-off values for respiratory muscle strength and endurance that can discriminate disability levels in individuals with MS. This gap highlights the absence of objective criteria that clinicians can rely on for early detection and for planning targeted rehabilitation interventions.

The present study aims to address this gap by identifying optimal cut-off points for respiratory muscle strength and endurance in individuals with MS to facilitate early and accurate discrimination of disability status. By doing so, this research seeks to make an original contribution to the literature. The findings are expected to support the standardization of respiratory assessment processes in clinical practice, thereby improving patient quality of life and enhancing the efficiency of healthcare services. Furthermore, the results will provide a strong scientific basis for integrating respiratory function assessments into MS follow-up protocols and will offer a methodological framework for future intervention-oriented studies.

研究设计

研究类型
Observational
观察模型
Other
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

  • Diagnosed with multiple sclerosis,
  • Aged 18 years or older,
  • Able to communicate effectively (able to speak, understand, read, and comprehend Turkish),
  • No relapse within the past three months,
  • Clinically stable for at least the past one month,
  • No participation in respiratory-based rehabilitation programs within the past six months,
  • Voluntary participation in the study.

排除标准

  • Presence of neurological disorders other than multiple sclerosis,
  • Presence of autoimmune diseases other than multiple sclerosis (e.g., rheumatoid arthritis, type 1 diabetes mellitus, systemic lupus erythematosus),
  • Presence of chronic cardiac or pulmonary diseases that may affect respiratory muscle strength or pulmonary function, such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, or heart failure,
  • Pregnancy or breastfeeding,
  • Inability to comply with the testing procedures.

研究组 & 干预措施

Individuals with Multiple Sclerosis

Individuals diagnosed with multiple sclerosis undergoing assessment of respiratory muscle strength, respiratory muscle endurance, pulmonary function, walking performance, fatigue, and quality of life to determine optimal cut-off values for discriminating disability status.

干预措施: Respiratory Muscle Strength and Endurance Assessment (Other)

结局指标

主要结局

Respiratory Muscle Strength (Maximal Inspiratory and Expiratory Pressures)

时间窗: Baseline

Respiratory muscle strength will be assessed by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using an electronic mouth pressure device. Optimal cut-off values of respiratory muscle strength for discriminating disability status will be determined based on EDSS levels.

Respiratory Muscle Endurance

时间窗: Baseline

Respiratory muscle endurance will be evaluated using an incremental threshold loading protocol. The highest load sustained for at least one minute and the endurance index will be used to determine optimal cut-off values for distinguishing disability status in individuals with multiple sclerosis.

次要结局

  • Expanded Disability Status Scale (EDSS)(Baseline)
  • Pulmonary Function: Forced Expiratory Volume in 1 Second (FEV₁)(Baseline)
  • Pulmonary Function: Forced Vital Capacity (FVC)(Baseline)
  • Pulmonary Function: FEV₁/FVC Ratio(Baseline)
  • Pulmonary Function: Peak Expiratory Flow (PEF)(Baseline)
  • Pulmonary Function: Forced Expiratory Flow at 25-75% of FVC (FEF₂₅-₇₅)(Baseline)
  • Walking Speed (Timed 25-Foot Walk Test)(Baseline)
  • Perceived Walking Ability (Multiple Sclerosis Walking Scale-12)(Baseline)
  • Fatigue (Modified Fatigue Impact Scale)(Baseline)
  • Quality of Life (Multiple Sclerosis International Quality of Life Questionnaire)(Baseline)

研究者

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

Mehmet Kaan ALTUNOK

Lecturer

Selcuk University

研究点 (1)

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