Clinical trial NCT04660227: Exercise Training in Pediatric-Onset Multiple Sclerosis Patients
Official title: Effectiveness of Exercise Training in Pediatric-Onset Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Multiple Sclerosis
Keywords: Physical Activity
Physiotherapy
Degenerative diseases
Exercise
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with pediatric onset multiple sclerosis
* EDSS \<6
* Having internet access

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Leisure-Time Exercise Questionnaire (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: 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).
timeFrame: Baseline and end of weeks 8.
Secondary outcomes:
measure: 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).
timeFrame: Baseline and end of weeks 8.
measure: Knee Joint Proprioception Assessment with Biodex Multi-Joint System (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: 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).
timeFrame: Baseline and end of weeks 8.
measure: 6 Minute Walk Test (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: Timed 25-Foot Walk (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: Timed Up and Go (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: The Pediatric Quality of Life Inventory 4.0 (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
Other outcomes:
Locations:
city: Bakırkoy
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Istanbul
Study officials:
affiliation: Istanbul University-Cerrahpasa Institute of Postgraduate Education
name: Pelin Vural
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University-Cerrahpasa Faculty of Health Science
name: Yonca Zenginler Yazgan, PhD
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine, Department of Pediatric Neurology
name: Sema Saltık, Prof. Dr.
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Department of Pediatric Neurology
name: Serhat Güler, Assoc. Prof.
role: STUDY_CHAIR
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