NCT07152015

Brief Summary

The goal of this observational study is to evaluate the relationship between respiratory function and sarcopenia in people with multiple sclerosis. The main questions it aims to answer are: Is there a relationship between muscle structure and respiratory muscle strength/pulmonary function in MS patients? Undergo a single session of respiratory muscle strength measurement (e.g., maximal inspiratory pressure \[MIP\], maximal expiratory pressure \[MEP\]) Perform spirometry to assess pulmonary function

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

September 5, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

10 days

First QC Date

August 18, 2025

Last Update Submit

March 26, 2026

Conditions

Keywords

multiple sclerosissarcopeniainspiratory muscle strength

Outcome Measures

Primary Outcomes (5)

  • Forced Vital Capacity

    FVC, defined as the total volume of air that can be forcibly exhaled after full inspiration, will be recorded with spirometry using the Cosmed Pony FX device, following ATS guidelines.

    1 day (The evaluation will be done one-time)

  • Forced Expiratory Volume in 1 second (FEV1)

    FEV1, spirometric evaluation of the maximum volume of air exhaled in the first second of a forced breath, will be measured using the Cosmed Pony FX device (Rome, Italy) in accordance with ATS standards.

    1 day (The evaluation will be done one-time)

  • FEV1/FVC Ratio (%)

    The ratio of FEV1 to FVC (FEV1/FVC) will be obtained as an index of airflow limitation. This ratio will be calculated from spirometry values measured with the Cosmed Pony FX device under ATS standards.

    1 day (The evaluation will be done one-time)

  • Maximal Inspiratory Pressure

    MIP, reflecting inspiratory muscle strength, will be assessed through maximal inspiratory efforts against a closed airway, using the Cosmed Pony FX device according to ATS recommendations.

    1 day (The evaluation will be done one-time)

  • Maximal Expiratory Pressure

    MEP, representing expiratory muscle strength, will be determined by maximal expiratory efforts against a closed airway. Measurements will be obtained with the Cosmed Pony FX device (Rome, Italy) according to ATS standards

    1 day (The evaluation will be done one-time)

Secondary Outcomes (2)

  • and grip strength measurement

    1 day (The evaluation will be done one-time)

  • Skeletal Muscle Index (SMI, kg/m²)

    1 day (The evaluation will be done one-time)

Study Arms (2)

Sarcopenic MS

Nonsarcopenic MS

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patient with Multiple Sclerosis Disease

You may qualify if:

  • Being diagnosed with MS by a neurologist
  • Being diagnosed with Sarcopenia
  • No history of attacks in the last 3 months
  • Able to walk with and without support (EDSS\<6.5)

You may not qualify if:

  • Having concomitant lung and heart disease
  • Mini Mental score below 24
  • Being in pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Sawaya Y, Shiba T, Ishizaka M, Hirose T, Sato R, Kubo A, Urano T. Sarcopenia is not associated with inspiratory muscle strength but with expiratory muscle strength among older adults requiring long-term care/support. PeerJ. 2022 Feb 17;10:e12958. doi: 10.7717/peerj.12958. eCollection 2022.

    PMID: 35194529BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisSarcopenia

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Tuba Kolaylı Çerezci, PhD(c)

    Uskudar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 18, 2025

First Posted

September 3, 2025

Study Start

September 5, 2025

Primary Completion

September 15, 2025

Study Completion

September 20, 2025

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations