Clinical trial NCT05123924: Respiratory Functions in Pediatric-Onset Multiple Sclerosis
Official title: Respiratory Functions and Fatigue in Patients With Pediatric-Onset Multiple Sclerosis: A Comparative Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric-onset Multiple Sclerosis
Keywords: Pediatric-onset multiple sclerosis
Physiotherapy
Respiratory capacity
Fatigue
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 46
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of FEV1/FVC ratio
timeFrame: Baseline
Secondary outcomes:
measure: Evaluation of Forced Vital Capacity (FVC)
timeFrame: Baseline
measure: Evaluation of Forced Expiratory Volume in 1 second (FEV1)
timeFrame: Baseline
measure: Evaluation of Peak Expiratory Flow (PEF)
timeFrame: Baseline
measure: Evaluation of Respiratory Muscle Strength
timeFrame: Baseline
measure: Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakırköy
Study officials:
affiliation: Biruni University
name: Buket Akıncı, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpasa, Graduate Education Institute
name: Pelin Vural, MSc.
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Pediatric Neurology
name: Serhat Güler, MD
role: STUDY_CHAIR
References: