Respiratory Functions and Fatigue in Patients With Pediatric-Onset Multiple Sclerosis: A Comparative Cross-sectional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Evaluation of FEV1/FVC ratio
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteer to participate
- •Being diagnosed with pediatric onset multiple sclerosis
- •Being between the ages of 15-22
排除标准
- •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
结局指标
主要结局
Evaluation of FEV1/FVC ratio
时间窗: 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.
次要结局
- Evaluation of Forced Vital Capacity (FVC)(Baseline)
- Evaluation of Forced Expiratory Volume in 1 second (FEV1)(Baseline)
- Evaluation of Respiratory Muscle Strength(Baseline)
- Evaluation of Peak Expiratory Flow (PEF)(Baseline)
- Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale(Baseline)
研究者
Yonca Zenginler Yazgan
Principal Investigator
Istanbul University - Cerrahpasa (IUC)