Multiple Sclerosis, Sarcopenia and Respiration

March 26, 2026 updated by: tuba kolaylı, Uskudar University

Examination of Sarcopenia and Respiratory Functions in Multiple Sclerosis

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with Multiple Sclerosis Disease

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Sarcopenic MS
Nonsarcopenic MS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity
Time Frame: 1 day (The evaluation will be done one-time)
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)
Time Frame: 1 day (The evaluation will be done one-time)
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 (%)
Time Frame: 1 day (The evaluation will be done one-time)
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
Time Frame: 1 day (The evaluation will be done one-time)
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
Time Frame: 1 day (The evaluation will be done one-time)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
and grip strength measurement
Time Frame: 1 day (The evaluation will be done one-time)
Muscle strength assessment will do by measuring handgrip strength. The measurement is performed with the JAMAR hand dynamometer upon the recommendation of the American Hand Therapists Association.
1 day (The evaluation will be done one-time)
Skeletal Muscle Index (SMI, kg/m²)
Time Frame: 1 day (The evaluation will be done one-time)
Skeletal Muscle Index (SMI) will be assessed using bioelectrical impedance analysis (BIA). SMI will be calculated as appendicular skeletal muscle mass (kg) divided by height squared (m²). Measurements will be performed once at baseline under standard BIA testing conditions.
1 day (The evaluation will be done one-time)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Investigators

  • Principal Investigator: Tuba Kolaylı Çerezci, PhD(c), Uskudar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2025

Primary Completion (Actual)

September 15, 2025

Study Completion (Actual)

September 20, 2025

Study Registration Dates

First Submitted

August 18, 2025

First Submitted That Met QC Criteria

September 2, 2025

First Posted (Actual)

September 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sar123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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