Clinical trial NCT06870968: FIT-ATOMIC Exercise Feasibility Trial
Official title: An Exercise Training Intervention for Depressive Symptoms in Youth With MS: A Randomized Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neuroinflammatory Diseases
Multiple Sclerosis
Keywords: multiple sclerosis
physical activity
depression
exercise intervention
biomarkers
irisin
brain-derived neurotrophic factor BDNF
randomized controlled trial
feasibility study
home-based exercise
youth
children
pediatric
brain and mental health
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
name: Multiple Sclerosis Society of Canada
name: University of California, San Diego
name: Children's Hospital of Philadelphia
name: Alberta Health Services, Calgary
name: Queen's University
name: University of Illinois at Chicago
name: Unity Health Toronto
First posted: 2025-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized at the time of enrolment to either an Exercise Training group or a Mobility and Flexibility Training group.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: 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 help manage symptoms, but there is growing interest in non-medication approaches, like exercise, to enhance the overall well-being of youth with MS. This study aims to investigate whether a structured exercise program can benefit physical fitness, mental health, and brain function in young people living with MS.

Study Design: This feasibility trial will enroll approximately 40 participants from four different locations in Canada and the United States. These participants will be youth diagnosed with MS.

Participants will be randomly assigned to one of two groups:

1. Exercise Training Group: Participants will follow a 20-week home-based exercise program, which includes structured exercises designed to improve physical fitness.
2. Mobility and Flexibility Training: Participants in this group will follow a 20-week program focused on mobility and flexibility exercises.

The study will collect data through various assessments, including:

* Clinical Exams: To monitor physical health and MS-related symptoms.
* Brain MRI: To measure changes in brain structure.
* Eye Tracking (SickKids participants only): To assess brain activity and cognitive functions.
* Cognitive Testing: To evaluate memory, attention, and other cognitive abilities.
* Blood Draws: To measure blood biomarkers related to brain health, such as Brain-Derived Neurotrophic Factor (BDNF) and irisin, which are proteins thought to be linked to exercise benefits.
* Questionnaires: To gather information on mental health, including levels of depression and overall well-being.
* Accelerometry: To measure physical activity levels throughout the study.

What the Investigators Hope to Learn: The main goal of this study is to see whether it is practical to run a large-scale trial using a home-based exercise program for youth with MS. The investigators will look at whether it is possible to successfully recruit, retain, and engage participants in the program and how well they adhere to the exercise plan.

In addition to feasibility, the study has several exploratory objectives:

1. Mental Health: The investigators want to see if participants in the exercise group show improvements in depressive symptoms compared to the control group.
2. Cognition: The investigators will evaluate whether exercise has a positive effect on thinking skills, such as memory and attention.
3. Brain Health: Through brain MRI scans, the investigators will examine whether exercise protects or enhances brain volume in areas linked to MS.
4. Fitness Levels: The investigators will measure if participants improve their physical fitness as a result of the exercise program.
5. Biomarkers: The investigators will study how exercise impacts blood levels of BDNF and irisin, which may provide insight into the biological mechanisms behind the benefits of exercise.

Why It Matters: This study is a critical first step in determining if exercise can be a viable and effective way to improve the lives of youth with MS. If successful, the findings will pave the way for a larger trial that could lead to new, non-medication-based treatments to improve mental health, cognitive function, and overall well-being in young people with MS.

By addressing the gaps in understanding how exercise benefits youth with MS, this research could offer valuable insights into developing better care strategies for this population. The results will inform not only how future exercise programs are designed but also provide a deeper understanding of the biological mechanisms linking physical activity to brain health and mood in youth with MS.

Study Locations: The study will take place across four sites:

* SickKids (Toronto, Canada)
* Stollery Children's Hospital (Edmonton, Canada)
* Children's Hospital of Philadelphia (Philadelphia, USA)
* University of California, San Diego (San Diego, USA)

How This Study Will Help in the Future: The information the investigators gather from this feasibility trial will help shape a larger, more definitive study to further explore whether exercise can be widely implemented as a safe and effective treatment option for youth with MS. It could lead to new therapeutic strategies that do not rely solely on medication but focus on holistic approaches to health and wellness.

Eligibility criteria: 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

Primary outcomes:
measure: Participant accrual rate
timeFrame: From enrollment to the end of study
measure: Fidelity of delivering the intervention
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: Participant drop-out rate
timeFrame: From enrollment to the end of study
measure: Adverse event rate
timeFrame: From enrollment to the end of study
measure: Completion rate of study measures
timeFrame: From enrollment to the end of study
Secondary outcomes:
Other outcomes:
measure: Blood myokine irisin measurement
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: Blood brain-derived neurotrophic factor (BDNF) measurement
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: Change in brain volumes
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: Cognitive flexibility - Dimensional Change Card Sort test
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: Executive function (Inhibitory control and attention) - Flanker test
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: Information Processing Speed - Oral Symbol Digit Test (OSD)
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: Free viewing eye tracking - Saccades
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: Free viewing eye tracking - Fixations
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: PedsQL Core Module
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: Varni Pediatric Multidimensional Fatigue Scale (PedsQL-MFS)
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: The Centre for Epidemiological Studies Depression Scale Children's Rating Scale (CES-DC)
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: Screen for Anxiety-Related Disorders (SCARED)
timeFrame: From enrollment to the end of intervention at 20 weeks
measure: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: From enrollment to the end of intervention at 20 weeks
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Philadelphia
country: United States
facility: Children&#39;s Hospital of Philadelphia
state: Pennsylvania
city: Edmonton
country: Canada
facility: Stollery Children&#39;s Hospital
state: Alberta
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
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