Impact of Physical Activity on Cognitive Outcomes in Youth With Pediat

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

Stopped earlyNot a drug-phase studyRelapsing MSNCT03933020

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: Lack of patient interest in participating (for adult patients), and lack of parental consent to participate (for pediatric patients)

What was tested

Treatment tested

  • VR active video game intervention
  • Educational session

Compared with

  • Standard Management of Physical Activity

Safety

GroupParticipants at riskSerious adverse eventsDeaths
All Participants000

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)

    3 months

    Thinking and memory

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)

    6 months

    Thinking and memory

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)

    12 months

    Thinking and memory

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)

    3 months

    Thinking and memory

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)

    6 months

    Thinking and memory

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)

    12 months

    Thinking and memory

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised

    3 months

    Thinking and memory

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised

    6 months

    Thinking and memory

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised

    12 months

    Thinking and memory

Other measures (18)

  • Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)

    3 Month

    Quality of life (reported by participants)

  • Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)

    6 month

    Quality of life (reported by participants)

  • Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)

    12 month

    Quality of life (reported by participants)

  • Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)

    3 months

    Thinking and memoryFatigue

  • Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)

    6 month

    Thinking and memoryFatigue

  • Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)

    12 month

    Thinking and memoryFatigue

  • Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)

    3 month

    Mood and sleep

  • Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)

    6 month

    Mood and sleep

  • Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)

    12 month

    Mood and sleep

  • Distance Walked as Assessed by the Six Minute Walk Test (6MWT)

    6 months

    Walking and mobility

Who could take part

Relapsing MS · 15 to 25

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

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    History

      1. Started

        May 2019

      2. Main results due

        May 2019

      3. Finished

        May 2019

      4. Results posted

        May 2022

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