FIT-ATOMIC Exercise Feasibility Trial

Starting soon · Not applicable · Has a placebo group

Conditions studied: Neuroinflammatory Diseases, Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT06870968

Run by

The Hospital for Sick Children

People needed

40

Starts

2025-06-01

Expected to finish

2026-09-30

Last updated by the study team

2025-05-21

Who can join

Age: 11 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of California, San Diego — La Jolla, California, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Stollery Children's Hospital — Edmonton, Alberta, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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