Multiple SclerosisNCT07152015
Multiple Sclerosis, Sarcopenia and Respiration
An observational study of Multiple Sclerosis, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2025to 20 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient with Multiple Sclerosis Disease
Who may be able to join
- 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)
Who cannot join
- Having concomitant lung and heart disease
- Mini Mental score below 24
- Being in pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, sarcopenia, inspiratory muscle strength
- Medical subject headings
- Multiple Sclerosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenic MS | Not described | |
| Nonsarcopenic MS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 day (The evaluation will be done one-time)
Secondary outcomes (2)
and grip strength measurement
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.
Measured: 1 day (The evaluation will be done one-time)
Skeletal Muscle Index (SMI, kg/m²)
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.
Measured: 1 day (The evaluation will be done one-time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start5 Sep 2025
- Primary completion15 Sep 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tuba kolaylı, Uskudar University
- Investigators
- Tuba Kolaylı Çerezci, PhD(c), Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152015
- Sponsor's protocol ID
- sar123
- Status last verified
- Mar 2026
- First submitted
- 18 Aug 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35194529
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Sarcopenia and Respiratory Functions in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07152015
- Acronym / sponsor ID
- sar123
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, sarcopenia, inspiratory muscle strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenic MS | – | – |
| Nonsarcopenic MS | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient with Multiple Sclerosis Disease
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Having concomitant lung and heart disease
- Mini Mental score below 24
- Being in pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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
2 secondary outcomes
and grip strength measurement
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 35194529Sawaya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuba Kolaylı Çerezci, PhD(c) principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Uskudar 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 1 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (time frame: 1 day (The evaluation will be done one-time)). The study lists 5 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 NCT07152015, which also lists 1 linked publication.
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 1 Apr 2026.