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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Sarcopenic MS
Nonsarcopenic MS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uskudar University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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