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临床试验/NCT04660227
NCT04660227
已完成
不适用

Effectiveness of Exercise Training in Pediatric-Onset Multiple Sclerosis Patients

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 20 人2020年11月23日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Pediatric Multiple Sclerosis
发起方
Istanbul University - Cerrahpasa (IUC)
入组人数
20
试验地点
1
主要终点
The Leisure-Time Exercise Questionnaire (The change between the initial value and the value after 2 months will be evaluated).
状态
已完成
最后更新
2年前

概览

简要总结

Multiple sclerosis is one of the leading causes of disability in young adults. It is known that patients with pediatric onset multiple sclerosis (POMS) experience their first demyelinating attack before the age of 18. However, studies conducted with individuals with pediatric onset of multiple sclerosis have been reported to be few and have affected parameters such as physical activity, fatigue balance and quality of life. Therefore, this study is planned to consist of two stages. These are the following stages;

  1. Assessment of people with pediatric onset multiple sclerosis with the evaluation methods detailed below. After these evaluations, the relationship between the 6-minute walk test performance of the patients and other evaluations will be examined. Within the scope of the project, a publication will be prepared and uploaded with the data obtained from this stage.
  2. The patients are divided into two groups, one group is included in the online exercise program, and the other group is included in the exercise program after being put on the waiting list.

详细描述

People with pediatric onset multiple sclerosis (POMS) experience various sensory, motor, cerebellar and cognitive dysfunctions due to the destruction of the central nervous system. These disorders may cause limitation of physical activity in people with POMS. In a study comparing people with POMS with monophasic acquired demyelinating syndrome (mono-ADS) and healthy controls in terms of physical activity levels, it was reported that people with POMS performed less physical activity compared to other groups. In addition, it has been reported that people with POMS have increased complaints such as depression and fatigue and their quality of life decreases. The aim of this study is to (1) investigate functional exercise capacity and its relationship between physical activity level, muscle strength, balance, fatigue and quality of life in POMS patients and (2) examine the effect of online exercise training on physical activity, balance, fatigue and quality of life in POMS patients. Participants will be randomly divided into two groups, the online exercise program group and the control group, after the evaluations. Participants in the online exercise program group will be given a treatment protocol consisting of aerobic exercise and strengthening exercises in the presence of a physiotherapist for a total of 8 weeks, 1 hour on 2 days a week. The exercise program will be created according to the condition of the people and progression will be provided every 2 weeks. After the exercises are completed, cooling will be done with stretching exercises. Participants in the control group will be put on the waiting list after all assessment methods are applied and will be re-evaluated at the end of 8 weeks. Application of the exercise training online will prevent the difficulties of continuing the exercise program due to transportation problems, disability level or pandemic and will facilitate the participation of people with POMS in the study.

注册库
clinicaltrials.gov
开始日期
2020年11月23日
结束日期
2022年1月1日
最后更新
2年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
责任方
Principal Investigator
主要研究者

Pelin Vural

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

入排标准

入选标准

  • Being diagnosed with pediatric onset multiple sclerosis
  • Having internet access

排除标准

  • Having an orthopedic problem affecting its mobility
  • Blurred vision problem
  • Having another diagnosis in addition to the diagnosis of pediatric onset multiple sclerosis
  • Having had an attack or received corticosteroid treatment 3 months before participating in the study

结局指标

主要结局

The Leisure-Time Exercise Questionnaire (The change between the initial value and the value after 2 months will be evaluated).

时间窗: Baseline and end of weeks 8.

It is a self-reported questionnaire with two questions that measures the physical activity behavior of the participants. In the first question, the frequencies of mild, moderate and intense physical activity performed for more than 15 minutes in a normal week are questioned. Weekly frequencies of light, moderate, and vigorous physical activities are multiplied by 3, 5 and 9 metabolic equivalents, respectively, and the sum of the results is recorded as total leisure activity. Second question seeks the frequency of activity that causes sweating in a normal week is questioned. Less than 14 scores means insufficiently active/sedentary, 14-23 scores means moderately active and 24 scores or more means active. So higher scores better outcomes.

One-Week Step Count Measurement with Pedometer for Physical Activity Assessment (The change between the initial value and the value after 2 months will be evaluated).

时间窗: Baseline and end of weeks 8.

It is one of the objective methods used to evaluate physical activity. It is used to record the number of steps taken. The estimated step length is entered into the device and recorded as a step when the vertical oscillation of the body exceeds a certain threshold value. In our study, the number of steps taken by the participants during a week before and after treatment will be calculated and recorded. Higher scores better outcomes.

次要结局

  • Knee Joint Proprioception Assessment with Biodex Multi-Joint System (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • Timed 25-Foot Walk (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • Timed Up and Go (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • The Pediatric Quality of Life Inventory 4.0 (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • Evaluation of Isokinetic Muscle Strength of Quadriceps and Hamstring Muscles with Biodex Multi-Joint System (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • Static and Dynamic Postural Stability Assessment with Biodex Balance System (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • 6 Minute Walk Test (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)

研究点 (1)

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