Clinical Trial

FIT-ATOMIC Exercise Feasibility Trial

Study acronym: FIT-ATOMIC
Not Yet Recruiting
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Summary
This multi-center, randomized controlled feasibility trial will assess a 20-week home-based exercise intervention in youth with Multiple Sclerosis (MS). The goal is to determine the feasibility of conducting a larger, definitive trial on exercise training as a non-pharmacological approach to improve disease outcomes in this population. Participants will be randomized to either an Exercise Training group or a Mobility and Flexibility Training group. The investigators will evaluate differences between the two groups in physical activity levels, mediators of physical activity, and psychosocial outcomes. Assessments, including clinical exams, brain MRI, eye tracking, cognitive testing, blood draws, and questionnaires, will occur at baseline and after 20 weeks. Accelerometry will be done at baseline, 10 weeks, and 20 weeks to track physical activity. The primary objectives are to assess the feasibility of recruiting, retaining, and randomizing youth with MS and to evaluate adherence to the exercise intervention and coaching sessions. Exploratory objectives include examining changes in depressive symptoms, cognitive function, blood biomarkers (BDNF and irisin), brain volume, and fitness levels in response to the intervention. Approximately 40 participants will be enrolled from four sites in Canada and the United States. Primary outcomes include feasibility, acceptability, and fidelity measures. Exploratory outcomes include blood biomarkers, brain MRI, cognitive testing, and other neuropsychological measures.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-06.
Trial Details
NCT Number NCT06870968
Lead Sponsor The Hospital for Sick Children
Collaborators: National Multiple Sclerosis Society, Multiple Sclerosis Society of Canada, University of California, San Diego, Children's Hospital of Philadelphia, Alberta Health Services, Calgary, Queen's University, University of Illinois at Chicago, Unity Health Toronto
Conditions Neuroinflammatory Diseases, Multiple Sclerosis
Enrollment 40 participants
Start Date 2025-06
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-21