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Multiple SclerosisNCT07373704

Respiratory Muscle Strength and Endurance Cut-Offs in Multiple Sclerosis

An observational study of Multiple Sclerosis, run by Selcuk University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Respiratory Muscle Strength and Endurance Assessment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Feb 2026to 30 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mehmet K ALTUNOK, PHD(c) in PT contact

5558175133 ext. +90

mehmetkaan.altunok@selcuk.edu.tr

Turkey (Türkiye)1 site
  • Selcuk University Faculty of Medicine Hospital MS Life Center

    Konya, Selcuklu, 42130

    Mehmet K ALTUNOK, PHD(c) in PT, 5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Being tested
Respiratory Muscle Strength and Endurance Assessment
Keywords
Multiple Sclerosis, Respiratory Muscle Strength, Respiratory Muscle Endurance, Pulmonary Function, Maximal Inspiratory Pressure, Maximal Expiratory Pressure, Cut-Off Values, EDSS
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Respiratory Muscle Strength and Endurance AssessmentOther

    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.

Study groups in NCT07373704
Study groupRoleWhat they receive
Individuals with Multiple SclerosisIndividuals 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.
Receives: Other: Respiratory Muscle Strength and Endurance Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Baseline

Secondary outcomes (10)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline

  5. Pulmonary Function: Peak Expiratory Flow (PEF)

    Peak Expiratory Flow (PEF) will be measured using spirometry and reported in liters per second to assess maximal expiratory flow capacity.

    Measured: Baseline

  6. Pulmonary Function: Forced Expiratory Flow at 25-75% of FVC (FEF₂₅-₇₅)

    Forced Expiratory Flow between 25% and 75% of FVC (FEF₂₅-₇₅) will be assessed using spirometry as an indicator of mid-expiratory airflow and small airway function.

    Measured: Baseline

  7. Walking Speed (Timed 25-Foot Walk Test)

    Walking speed will be evaluated using the Timed 25-Foot Walk test and examined in relation to respiratory muscle strength and endurance measures.

    Measured: Baseline

  8. Perceived Walking Ability (Multiple Sclerosis Walking Scale-12)

    Perceived walking ability will be assessed using the Multiple Sclerosis Walking Scale-12 (MSWS-12), a 12-item patient-reported outcome measure of walking impairment in individuals with multiple sclerosis. The total score is transformed to a 0-100 scale, with higher scores indicating greater walking impairment and worse perceived walking ability. MSWS-12 scores will be analyzed as clinical correlates of respiratory muscle strength and endurance.

    Measured: Baseline

  9. Fatigue (Modified Fatigue Impact Scale)

    Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS), a 21-item self-report questionnaire evaluating the impact of fatigue on physical, cognitive, and psychosocial functioning in individuals with multiple sclerosis. The total MFIS score ranges from 0 to 84, with higher scores indicating greater fatigue impact and worse fatigue-related outcomes. MFIS scores will be examined in relation to respiratory muscle strength and endurance.

    Measured: Baseline

  10. Quality of Life (Multiple Sclerosis International Quality of Life Questionnaire)

    Quality of life will be assessed using the Multiple Sclerosis International Quality of Life questionnaire (MusiQoL-31), a 31-item self-administered, multidimensional instrument specifically developed for individuals with multiple sclerosis. MusiQoL scores are linearly transformed to a 0-100 scale, with higher scores indicating better quality of life. MusiQoL-31 scores will be analyzed as clinical correlates of respiratory muscle strength and endurance.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study start2 Feb 2026 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07373704
Sponsor's protocol ID
SelcukU_PT_MS_RESP_ENDURANCE_1
Status last verified
Jan 2026
First submitted
15 Jan 2026
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bosnak-Guclu M, Gunduz AG, Nazliel B, Irkec C. Comparison of functional exercise capacity, pulmonary function and respiratory muscle strength in patients with multiple sclerosis with different disability levels and healthy controls. J Rehabil Med. 2012 Jan;44(1):80-6. doi: 10.2340/16501977-0900.

    PubMed 22234321
  • Mutluay FK, Gurses HN, Saip S. Effects of multiple sclerosis on respiratory functions. Clin Rehabil. 2005 Jun;19(4):426-32. doi: 10.1191/0269215505cr782oa.

    PubMed 15929512
  • Altintas A, Demir T, Ikitimur HD, Yildirim N. Pulmonary function in multiple sclerosis without any respiratory complaints. Clin Neurol Neurosurg. 2007 Apr;109(3):242-6. doi: 10.1016/j.clineuro.2006.09.004. Epub 2006 Oct 13.

    PubMed 17046152
  • Brown TR, Kraft GH. Exercise and rehabilitation for individuals with multiple sclerosis. Phys Med Rehabil Clin N Am. 2005 May;16(2):513-55. doi: 10.1016/j.pmr.2005.01.005.

    PubMed 15893685
  • Bishop M, Rumrill PD. Multiple sclerosis: Etiology, symptoms, incidence and prevalence, and implications for community living and employment. Work. 2015;52(4):725-34. doi: 10.3233/WOR-152200.

    PubMed 26639011
  • Tremlett H, Paty D, Devonshire V. Disability progression in multiple sclerosis is slower than previously reported. Neurology. 2006 Jan 24;66(2):172-7. doi: 10.1212/01.wnl.0000194259.90286.fe.

    PubMed 16434648
  • Calabresi PA. Diagnosis and management of multiple sclerosis. Am Fam Physician. 2004 Nov 15;70(10):1935-44.

    PubMed 15571060
  • Centonze D, Leocani L, Feys P. Advances in physical rehabilitation of multiple sclerosis. Curr Opin Neurol. 2020 Jun;33(3):255-261. doi: 10.1097/WCO.0000000000000816.

    PubMed 32304436

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Selcuk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehmet K ALTUNOK, PHD(c) in PT (5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory Muscle Strength (Maximal Inspiratory and Expiratory Pressures) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07373704, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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