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FIT-ATOMIC Exercise Feasibility Trial

Study acronym: FIT-ATOMIC
StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated May 21, 2025 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Notable Start date: Mar 2025 to Jun 2025v2 Show 4 more changesShow less
    • Interventions: Exercise Training Intervention (Behavioral), Mobility and Flexibility Training (Behavioral) to Exercise Training (Behavioral), Mobility and Flexibility Training (Behavioral)
    • Study description shortened, about 20 words
    • Site contacts updated at 4 of 4 sites
    • Publications: details revised at 16 of 16 entries
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)
Neuroinflammatory Diseases, Multiple Sclerosis
Related terms Depression, Motor Activity, Multiple Sclerosis, Neuroinflammatory Diseases, Psychological Well-Being
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov