FIT-ATOMIC Exercise Feasibility Trial
Sponsored by The Hospital for Sick Children
About this study
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.
Overview: This research study explores the potential of exercise as a non-pharmacological treatment for youth with Multiple Sclerosis (MS). The investigators are conducting a 20-week home-based exercise program to determine if it is feasible to implement this type of intervention in a larger trial in the future. Our ultimate goal is to understand how exercise might help improve both physical and mental health outcomes for youth with MS. Why This Study is Important: Multiple Sclerosis is a chronic disease that affects the brain and spinal cord, often leading to issues with movement, balance, vision, and other body functions. In young people, MS can have a significant impact on daily life, including mental health and cognitive abilities (such as memory and problem-solving). Medications can …
Where this study is enrolling (2)
- I'm interested
University of California, San Diego
La Jolla, California
- I'm interested
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
Who can participate
Inclusion criteria
- ✓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 criteria
- ✕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
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Trial data sourced from ClinicalTrials.gov.