Respiratory Functions in Pediatric-Onset Multiple Sclerosis

November 5, 2021 updated by: Yonca Zenginler Yazgan, Istanbul University - Cerrahpasa (IUC)

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.

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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 (Anticipated)

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.
46

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 Contact Backup

Study Locations

  • Turkey
    • Bakırköy
      • Istanbul, Bakırköy, Turkey, 34100

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

15 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Volunteer to participate
  • Being diagnosed with pediatric onset multiple sclerosis
  • Being between the ages of 15-22
  • EDSS <6

Exclusion Criteria:

  • 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

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.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
POMS Group
Individuals in the POMS group will be evaluated in terms of respiratory capacity, respiratory muscle strength and fatigue.
Other: Evaluation of respiratory capacity, respiratory muscle strength and fatigue
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.
Control Group
Individuals in the control group will be evaluated in terms of respiratory capacity, respiratory muscle strength and fatigue.
Other: Evaluation of respiratory capacity, respiratory muscle strength and fatigue
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.

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
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.
Baseline

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
Evaluation of Forced Vital Capacity (FVC)
Time Frame: Baseline
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.
Baseline
Evaluation of Forced Expiratory Volume in 1 second (FEV1)
Time Frame: Baseline
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.
Baseline
Evaluation of Peak Expiratory Flow (PEF)
Time Frame: Baseline
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.
Baseline
Evaluation of Respiratory Muscle Strength
Time Frame: Baseline
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.
Baseline
Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale
Time Frame: Baseline
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.
Baseline

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.
Istanbul University - Cerrahpasa (IUC)

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.
  • Study Chair: Buket Akıncı, Assoc. Prof., Biruni University
  • Study Chair: Pelin Vural, MSc., Istanbul University-Cerrahpasa, Graduate Education Institute
  • Study Chair: Serhat Güler, MD, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Pediatric Neurology

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.
October 29, 2021

Primary Completion (Anticipated)

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.
June 1, 2022

Study Completion (Anticipated)

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.
July 1, 2022

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).
November 5, 2021

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.
November 5, 2021

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.
November 17, 2021

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.
November 17, 2021

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.
November 5, 2021

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.
November 1, 2021

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.
  • IUC-2021-68

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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