Pediatric-onset Multiple SclerosisNCT05123924
Respiratory Functions in Pediatric-Onset Multiple Sclerosis
An observational study of Pediatric-onset Multiple Sclerosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Pediatric-onset multiple sclerosis (POMS) is a chronic, autoimmune and inflammatory disease of the central nervous system that begins before the age of 18 years. POMS patients are affected in terms of physical capacity, cognitive status and fatigue compared with their healthy peers that has been reported. Read more about this study
- Who is it for?
- Ages 15 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric-onset Multiple Sclerosis
- What is being tested?
- Evaluation of respiratory capacity, respiratory muscle strength and fatigue
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Oct 2021to Jul 2022
- 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 15 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Thirty patients with POMS who were diagnosed with pediatric-onset multiple sclerosis and met the inclusion criteria will be included in the study. Sample size, Gravesande et al. According to the child form in the PedsQL Multidimensional Fatigue Questionnaire, which they used in their study, according to the total fatigue scores (difference Δ 10.21), in POMS patients (61.57±20.78) and healthy individuals of the same age group (71.78±15.58), with 0.05 margin of error and 80% power. calculated. According to this calculation, it was seen that 25 patients with POMS and 13 healthy individuals who were matched for age and sex (2:1 distribution) should be included in our study.
Who may be able to join
- Volunteer to participate
- Being diagnosed with pediatric onset multiple sclerosis
- Being between the ages of 15-22
- EDSS <6
Who cannot join
- Having another diagnosis in addition to the diagnosis of pediatric-onset multiple sclerosis
- Having a blurred vision problem
- Having had an attack or received corticosteroid treatment 3 months before participating in the study
Trial locations and contacts
1 site in 1 country.
Yonca Zenginler Yazgan, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa
Istanbul, Bakırköy, 34100
Yonca Zenginler Yazgan, PhD, yoncazenginler@gmail.com
About this study
Official title: Respiratory Functions and Fatigue in Patients With Pediatric-Onset Multiple Sclerosis: A Comparative Cross-sectional Study
Pediatric-onset multiple sclerosis (POMS) is a chronic, autoimmune and inflammatory disease of the central nervous system that begins before the age of 18 years. POMS patients are affected in terms of physical capacity, cognitive status and fatigue compared with their healthy peers that has been reported. It has been reported that although individuals with MS with low disability levels do not have respiratory complaints, respiratory parameters may be affected. Therefore, it is necessary to evaluate respiratory capacity, respiratory muscle strength and fatigue levels of POMS patients. Evaluations will help prevent future complications by detecting any existing problems early.
Read the detailed description
People with pediatric onset multiple sclerosis (POMS) may experience sensory, motor, cerebellar and cognitive dysfunctions due to the destruction of the central nervous system. These disorders can cause decrease in physical capacity, increase in cognitive symptoms and fatigue level in patients with POMS. There is no study in the literature examining the relationship between respiratory capacity and respiratory muscle strength with fatigue in POMS patients. The aim of this study is to compare POMS patients and healthy controls in terms of respiratory capacity, respiratory muscle strength and fatigue. All participants's respiratory function will be evaluated with "Minispir Light Spirometer", respiratory muscle strength with "MD Diagnostics RP Check" and fatigue with Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale. Evaluations will not be repeated after a certain interval.As a result of the comparison of both groups, it will be determined whether POMS patients have difficulties or not.
- Conditions
- Pediatric-onset Multiple Sclerosis
- Being tested
- Evaluation of respiratory capacity, respiratory muscle strength and fatigue
- Keywords
- Pediatric-onset multiple sclerosis, Physiotherapy, Respiratory capacity, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of respiratory capacity, respiratory muscle strength and fatigueOther
The demographic information of the participants will be taken with the form prepared for the people in this group. Then, respiratory function with "Minispir Light Spirometer", respiratory muscle strength with "MD Diagnostics RP Check" and fatigue with Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale will be evaluated. All assessments will be completed on the same day and will not be repeated after a certain period of time.
| Study group | Role | What they receive |
|---|---|---|
| POMS Group | Individuals in the POMS group will be evaluated in terms of respiratory capacity, respiratory muscle strength and fatigue. Receives: Other: Evaluation of respiratory capacity, respiratory muscle strength and fatigue | |
| Control Group | Individuals in the control group will be evaluated in terms of respiratory capacity, respiratory muscle strength and fatigue. Receives: Other: Evaluation of respiratory capacity, respiratory muscle strength and fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of FEV1/FVC ratio
The Minispir Light Spirometer will be used to assess the respiratory function of the participants. Before starting the spirometric test, how to do the test will be explained. Before starting the test, the participant will be asked to sit with their back straight and put on the nose clip provided. Then the participant will take the disposable bacterial filter mouthpiece between his lips and hold it tightly. The person will be asked to take a few normal breaths followed by as deep a breath as possible and instructed to exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds. If the participant will coughs or cannot breathe deeply enough during the test, the test will terminated and the test will repeated after 20 minutes of rest. The FEV1/FVC ratio with the highest value from three consecutive correctly performed tests will be recorded.
Measured: Baseline
Secondary outcomes (5)
Evaluation of Forced Vital Capacity (FVC)
The Minispir Light Spirometer will be used for FVC evaluation. Before starting the test, it will be explained how to do the test. The participant will be asked to sit with their back straight and put on the nose clip provided. Then the participant will take the disposable bacteria filter mouthpiece between his lips and holds it tightly. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds. If the participant coughs or cannot breathe deeply enough during the test, the test is terminated and the test is repeated after 20 minutes of rest. The highest FVC value from three correctly performed consecutive tests will be recorded.
Measured: Baseline
Evaluation of Forced Expiratory Volume in 1 second (FEV1)
The Minispir Light Spirometer will be used for FEV1 evaluation. Before starting the test, it will be explained how to do the test. The participant will be asked to sit with their back straight and put on the nose clip provided. Then the participant will take the disposable bacteria filter mouthpiece between his lips and holds it tightly. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds. If the participant coughs or cannot breathe deeply enough during the test, the test is terminated and the test is repeated after 20 minutes of rest. The highest FEV1 value from three correctly performed consecutive tests will be recorded.
Measured: Baseline
Evaluation of Peak Expiratory Flow (PEF)
The Minispir Light Spirometer will be used for PEF evaluation. Minispir Light Spirometer will be used for PEF evaluation. Before starting the test, it will be explained how to do the test. The participant will be asked to sit with their back straight and put on the nose clip provided. Then the participant will take the disposable bacteria filter mouthpiece between his lips and holds it tightly. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds. If the participant coughs or cannot breathe deeply enough during the test, the test is terminated and the test is repeated after 20 minutes of rest. The highest PEF value from three correctly performed consecutive tests will be recorded.
Measured: Baseline
Evaluation of Respiratory Muscle Strength
Evaluation of respiratory muscle strength will be done with the "MD Diagnostics RP Check" device in accordance with the guidelines of the American Thoracic Society (ATD) and the European Respiratory Society (ASD). The maximum expiratory pressure (MEP) and maximum inspiratory pressure (MIP) of each participant will be measured. Before starting the test, it will be explained how to do the test. During the assessment, the participant will be asked to sit with his back straight and put on the nose clip provided. Then, for the MEP evaluation, the patient will be asked to take a deep breath and blow the whole breath forcefully into the device with a disposable bacteria filter mouthpiece. For the MIP evaluation, the patient will be asked to breathe strongly through the device with a disposable bacteria filter mouthpiece after exhaling the whole breath. Appropriate breaks will be given between assessments. Three correctly performed attempts for MEP and MIP measurements will be recorded.
Measured: Baseline
Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale
The Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale is a valid and reliable scale for assessing fatigue in the pediatric population. This 18-item symptom-focused scale evaluates 3 areas of fatigue (general, sleep/rest, and cognitive). Each question is scored on a 5-point Likert system (0=Never, 1=Almost never, 2=Sometimes, 3=Frequently, 4=Always), and high scores indicate higher levels of fatigue. In our study, both the child form and the family form of the scale will be used.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start29 Oct 2021
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (estimated)
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 Pediatric-onset 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonca Zenginler Yazgan, Istanbul University - Cerrahpasa
- Investigators
- Buket Akıncı, Assoc. Prof., Study chair, Biruni UniversityPelin Vural, MSc., Study chair, Istanbul University-Cerrahpasa, Graduate Education InstituteSerhat Güler, MD, Study chair, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Pediatric Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123924
- Sponsor's protocol ID
- IUC-2021-68
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vural P, Akinci B, Guler S, Saltik S, Yazgan YZ. Respiratory functions, respiratory muscle strength and fatigue in patients with pediatric-onset multiple sclerosis: a comparative cross-sectional study. Acta Neurol Belg. 2025 Feb;125(1):69-75. doi: 10.1007/s13760-024-02628-4. Epub 2024 Aug 21.
PubMed 39168946
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Functions and Fatigue in Patients With Pediatric-Onset Multiple Sclerosis: A Comparative Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05123924
- Acronym / sponsor ID
- IUC-2021-68
- Conditions
- Pediatric-onset Multiple Sclerosis
- Keywords
- Pediatric-onset multiple sclerosis, Physiotherapy, Respiratory capacity, Fatigue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 17 Nov 2021 (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.
Pediatric-onset multiple sclerosis (POMS) is a chronic, autoimmune and inflammatory disease of the central nervous system that begins before the age of 18 years. POMS patients are affected in terms of physical capacity, cognitive status and fatigue compared with their healthy peers that has been reported. It has been reported that although individuals with MS with low disability levels do not have respiratory complaints, respiratory parameters may be affected. Therefore, it is necessary to evaluate respiratory capacity, respiratory muscle strength and fatigue levels of POMS patients. Evaluations will help prevent future complications by detecting any existing problems early.
Detailed description
People with pediatric onset multiple sclerosis (POMS) may experience sensory, motor, cerebellar and cognitive dysfunctions due to the destruction of the central nervous system. These disorders can cause decrease in physical capacity, increase in cognitive symptoms and fatigue level in patients with POMS. There is no study in the literature examining the relationship between respiratory capacity and respiratory muscle strength with fatigue in POMS patients. The aim of this study is to compare POMS patients and healthy controls in terms of respiratory capacity, respiratory muscle strength and fatigue. All participants's respiratory function will be evaluated with "Minispir Light Spirometer", respiratory muscle strength with "MD Diagnostics RP Check" and fatigue with Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale. Evaluations will not be repeated after a certain interval.As a result of the comparison of both groups, it will be determined whether POMS patients have difficulties or not.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POMS Group | – | Other: Evaluation of respiratory capacity, respiratory muscle strength and fatigueIndividuals in the POMS group will be evaluated in terms of respiratory capacity, respiratory muscle strength and fatigue. |
| Control Group | – | Other: Evaluation of respiratory capacity, respiratory muscle strength and fatigueIndividuals in the control group will be evaluated in terms of respiratory capacity, respiratory muscle strength and fatigue. |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Thirty patients with POMS who were diagnosed with pediatric-onset multiple sclerosis and met the inclusion criteria will be included in the study. Sample size, Gravesande et al. According to the child form in the PedsQL Multidimensional Fatigue Questionnaire, which they used in their study, according to the total fatigue scores (difference Δ 10.21), in POMS patients (61.57±20.78) and healthy individuals of the same age group (71.78±15.58), with 0.05 margin of error and 80% power. calculated. According to this calculation, it was seen that 25 patients with POMS and 13 healthy individuals who were matched for age and sex (2:1 distribution) should be included in our study.
Key inclusion criteria (4 listed)
- Volunteer to participate
- Being diagnosed with pediatric onset multiple sclerosis
- Being between the ages of 15-22
- EDSS <6
Key exclusion criteria (3 listed)
- Having another diagnosis in addition to the diagnosis of pediatric-onset multiple sclerosis
- Having a blurred vision problem
- Having had an attack or received corticosteroid treatment 3 months before participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of respiratory capacity, respiratory muscle strength and fatigueThe demographic information of the participants will be taken with the form prepared for the people in this group. Then, respiratory function with "Minispir Light Spirometer", respiratory muscle strength with "MD Diagnostics RP Check" and fatigue with Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale will be evaluated. All assessments will be completed on the same day and will not be repeated after a certain period of time. | Other | Control Group, POMS Group |
Primary outcome
Evaluation of FEV1/FVC ratio
Time frame: Baseline
The Minispir Light Spirometer will be used to assess the respiratory function of the participants. Before starting the spirometric test, how to do the test will be explained. Before starting the test, the participant will be asked to sit with their back straight and put on the nose clip provided. Then the participant will take the disposable bacterial filter mouthpiece between his lips and hold it tightly. The person will be asked to take a few normal breaths followed by as deep a breath as possible and instructed to exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds. If the participant will coughs or cannot breathe deeply enough during the test, the test will terminated and the test will repeated after 20 minutes of rest. The FEV1/FVC ratio with the highest value from three consecutive correctly performed tests will be recorded.
5 secondary outcomes
Evaluation of Forced Vital Capacity (FVC)
Time frame: Baseline
Evaluation of Forced Expiratory Volume in 1 second (FEV1)
Time frame: Baseline
Evaluation of Peak Expiratory Flow (PEF)
Time frame: Baseline
Evaluation of Respiratory Muscle Strength
Time frame: Baseline
Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Derived from this study: PubMed 39168946Vural P, Akinci B, Guler S, Saltik S, Yazgan YZ. Respiratory functions, respiratory muscle strength and fatigue in patients with pediatric-onset multiple sclerosis: a comparative cross-sectional study. Acta Neurol Belg. 2025 Feb;125(1):69-75. doi: 10.1007/s13760-024-02628-4. Epub 2024 Aug 21.
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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.
Yonca Zenginler Yazgan, PhD contact
Buket Akıncı, Assoc. Prof. study chair
Biruni University
Pelin Vural, MSc. study chair
Istanbul University-Cerrahpasa, Graduate Education Institute
Serhat Güler, MD study chair
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Pediatric Neurology
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 Pediatric-onset Multiple Sclerosis, run by Istanbul University - Cerrahpasa 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: status not confirmed, as of the sponsor's last update on 17 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonca Zenginler Yazgan, PhD (yoncazenginler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of FEV1/FVC ratio (time frame: Baseline). 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 NCT05123924, 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 17 Nov 2021.