FIT-ATOMIC Exercise Feasibility Trial for Youth with MS

This study is looking at whether a home-based exercise program is a good way to help young people (ages 11-25) with Multiple Sclerosis (MS) or clinically isolated syndrome. We want to see if it's possible to do a larger study on exercise as a way to improve health for this group. Participants will be randomly assigned to either an Exercise Training group or a Mobility and Flexibility Training group for 20 weeks. We will compare how these groups affect physical activity, mental well-being, and other health measures. The main goals are to see how many people join, how well the exercise program is delivered, and how many people complete the study.

Study design
This is a randomized controlled feasibility trial involving about 40 participants. Participants will be assigned by chance to one of two groups.
What's involved
You would participate in three weekly exercise sessions for 20 weeks. Assessments, including clinical exams, brain MRI, eye tracking, cognitive testing, blood draws, and questionnaires, will happen at the beginning and after 20 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study measures participant drop-out rate from enrollment to the end of the study, which is 20 weeks after the intervention begins.

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NCT06870968

FIT-ATOMIC Exercise Feasibility Trial

Not Yet Recruiting
NAAges 11–25InterventionalBasic science
The Hospital for Sick Children
~40 participants
Updated 2025-05-21 on ClinicalTrials.gov
What's tested:Exercise TrainingMobility and Flexibility Training

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participant accrual rate
Measured over From enrollment to the end of study
+4 more outcomes measured
Neuroinflammatory Diseases
Multiple Sclerosis
4 sites across 4 states
California1
Pennsylvania1
Alberta1
Ontario1

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Eligibility criteria

Inclusion

Youth and young adults 11-25 years of age
MS diagnosis or clinically isolated syndrome per revised McDonald diagnostic criteria and International Pediatric MS Study Group Criteria
A score of 10 or above on the CES-DC scale.

Exclusion

Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities
Do not speak and read English at a level needed to complete the questionnaires (4th grade level)
Have significant motor disability (EDSS ≥4)
Are at increased risk of cardiac or other complications of exercise testing, as determined by the pediatric neurologist or physician
  • Participant accrual rateFrom enrollment to the end of study

    Number of participants enrolled per year

  • Fidelity of delivering the interventionFrom enrollment to the end of intervention at 20 weeks

    ASPIRE fidelity coaching checklist. This measure assesses the fidelity with which study coaches deliver the intervention during calls with participants. Participants are scored on a scale from 0 to 2, based on the extent to which the intervention components are covered: 0: Did not cover - The intervention component was not addressed during the call. 1. Partially covered - The intervention component was addressed to some extent, but not fully. 2. Fully covered - The intervention component was fully addressed, meeting the intended criteria for delivery. A higher score reflects a more complete and accurate delivery of the intervention as planned.

  • Participant drop-out rateFrom enrollment to the end of study

    Percentage of total patients that dropped out of study.

  • Adverse event rateFrom enrollment to the end of study

    Number of adverse events per total participants

  • Completion rate of study measuresFrom enrollment to the end of study

    Percentage of total patients that completed the study measures.