Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-Onset Multiple Sclerosis (POMS)

Study Overview
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Brief Summary
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The purpose of this study is to to determine how implementing a home-based virtual reality video (VR) game exercise program in young people with Multiple Sclerosis(MS) can improve disability outcomes by measuring its impact on cognitive assessments (BICAMS), subjective measures of cognitive, physical and psychosocial disability, and motor assessments (6MWT).

Official Title
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Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-onset Multiple Sclerosis

Conditions
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Pediatric Onset Multiple Sclerosis (POMS)

Intervention / Treatment
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* Device: VR active video game intervention
* Behavioral: Educational session
* Behavioral: Standard Management of Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of Pediatric-Onset MS (<18 years) according to the 2017 revised McDonald criteria (relapsing-remitting) Expanded Disability Status Scale (EDSS) ≤ 5.0 Relapse free for the past 30 days (including no corticosteroids) No contraindications to physical activity, including pregnancy Participant and parent (if between 15 and 18 years of age) written informed consent. Exclusion Criteria: History of visual provoked seizures EDSS > 5.0

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Group<br> | Device: VR active video game intervention<br>* The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise<br>Behavioral: Educational session<br>* This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.<br>|
| Active Comparator: Control Group<br> | Behavioral: Standard Management of Physical Activity<br>* Routine discussion of lifestyle factors including physical activity during clinic visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) | A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score. | 3 months | 
| Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) | A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score. | 6 months | 
| Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) | A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score. | 12 months | 
| Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II) | A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80). | 3 months | 
| Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II) | A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80). | 6 months | 
| Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II) | A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80). | 12 months | 
| Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised | A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12). | 3 months | 
| Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised | A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12). | 6 months | 
| Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised | A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) | 29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145. | 3 Month | 
| Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) | 29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145. | 6 month | 
| Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) | 29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145. | 12 month | 
| Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS) | 21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84. | 3 months | 
| Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS) | 21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84. | 6 month | 
| Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS) | 21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84. | 12 month | 
| Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS) | 14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21. | 3 month | 
| Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS) | 14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21. | 6 month | 
| Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS) | 14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21. | 12 month | 
| Distance Walked as Assessed by the Six Minute Walk Test (6MWT) | the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded | 6 months | 
| Distance Walked as Assessed by the Six Minute Walk Test (6MWT) | the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded | 12 months | 
| Number of Clinical Relapses | Assessment at each clinic visit | 12 months | 
| New Activity on MRI (T2 Lesions, Gd+) | Assessment at each MRI | 12 months | 
| Safety of Implementing a VR Active Video Game Program at Home as Assessed by the Number of Self-reported Incidents That Occur During the Exercise Sessions, Including Falls or Physical Injuries. |  | 1 month | 
| Safety of Implementing a VR Active Video Game Program at Home as Assessed by the Number of Self-reported Incidents That Occur During the Exercise Sessions, Including Falls or Physical Injuries. |  | 3 month | 
| Safety of Implementing a VR Active Video Game Program at Home as Assessed by the Number of Self-reported Incidents That Occur During the Exercise Sessions, Including Falls or Physical Injuries. |  | 6 month | 
| Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire |  | 6 months | 
| Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Cognitive Impairment, Physical activity