Respiratory Muscle Strength and Endurance Cut-Offs in Multiple Sclerosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSelcuk University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial population

Adults aged 18 years and older diagnosed with multiple sclerosis who are clinically stable, able to communicate effectively, and eligible for respiratory muscle strength and endurance assessments.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Respiratory Muscle Strength and Endurance Assessment

    Other intervention

    Participants will undergo a comprehensive assessment of respiratory muscle function, including respiratory muscle strength measured by maximal inspiratory and expiratory pressures and respiratory muscle endurance evaluated using an incremental threshold loading protocol. Pulmonary function will be assessed by spirometry. These assessments will be conducted to determine optimal cut-off values of respiratory muscle strength and endurance for discriminating disability status in individuals with multiple sclerosis and to examine their associations with clinical outcomes.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Individuals with Multiple Sclerosis1 intervention

Trial outcomes

Primary outcomes

1

Respiratory Muscle Strength (Maximal Inspiratory and Expiratory Pressures)

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.

Time frame
Baseline
2

Respiratory Muscle Endurance

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.

Time frame
Baseline

Secondary outcomes

1

Expanded Disability Status Scale (EDSS)

Disability status will be assessed using the Expanded Disability Status Scale (EDSS), a widely used measure of neurological disability in multiple sclerosis. The EDSS score ranges from 0 to 10, with higher scores indicating greater disability. A score of 0 represents normal neurological function, while a score of 10 indicates death due to multiple sclerosis. EDSS will be used as the reference standard for discrimination analyses.

Time frame
Baseline
2

Pulmonary Function: Forced Expiratory Volume in 1 Second (FEV₁)

Forced Expiratory Volume in one second (FEV₁) will be assessed using spirometry and reported in liters and as a percentage of predicted values. FEV₁ reflects expiratory airflow and pulmonary function.

Time frame
Baseline
3

Pulmonary Function: Forced Vital Capacity (FVC)

Forced Vital Capacity (FVC) will be measured using spirometry according to standardized American Thoracic Society and European Respiratory Society guidelines. FVC represents the maximum volume of air that can be forcibly exhaled after full inspiration and will be reported in liters and as a percentage of predicted values.

Time frame
Baseline
4

Pulmonary Function: FEV₁/FVC Ratio

The ratio of Forced Expiratory Volume in one second to Forced Vital Capacity (FEV₁/FVC) will be calculated from spirometric measurements and used to assess ventilatory patterns.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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