An interventional study of Exercise Training and Mobility and Flexibility Training in Neuroinflammatory Diseases and Multiple Sclerosis, sponsored by The Hospital for Sick Children. Not yet recruiting at 4 sites in 2 countries. Open to participants aged 11 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Basic science
Among 1,192 studies in Multiple Sclerosis with a site in United States — 185 open to participants now, 261 under way, 23 of them phase 3. Multiple Sclerosis · United States.
Among the 1,192 studies in Multiple Sclerosis with a site in United States, this one is the 480th largest by planned enrollment of the 879 interventional ones, is one of 57 that started in 2025, is one of 381 with no phase, reaches primary completion later than 60 of the 257 other live ones, and was the 1,082nd registered.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →185 of the 1,192 studies in Multiple Sclerosis with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 11 Years to 25 Years · all sexes · no healthy volunteers.
The full table on the hub →1,192 studies; the count open now beside each. This study's row is marked.
First in 1976; this study’s year is marked. 57 started in 2025.
Median enrollment 50 across the 879 interventional studies, 100 across the 302 observational. Of the 817 that completed or were terminated, 331 (41%) have results posted.
376 of 1,192 have an industry lead sponsor. The 10 most frequent:
The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
The Hospital for Sick Children has 7 studies filed under Multiple Sclerosis — fewer than ten, so there is no comparison to draw.
80 of the studies in Multiple Sclerosis with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05134441Phase 3Immunic AGStudy to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis | 2026-11 |
| NCT06847724Phase 3SandozComparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis | 2026-11 |
| NCT05877963Phase 3TG Therapeutics, Inc.Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab | 2027-01-21 |
| NCT06136728Phase 3MGH Institute of Health ProfessionsDalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis | 2027-05 |
| NCT06141473Phase 3SanofiEfficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | 2027-05-06 |
Among the 1,192 studies in Multiple Sclerosis with a site in United States, from their registry updates:
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 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:
The study will collect data through various assessments, including:
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:
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:
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.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Compared within Multiple Sclerosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neuroinflammatory Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The exercise training will follow a progressive interval-based training program designed for youth with MS. Participants will engage in three weekly exercise sessions. Participants will be given access to links to live virtual structured exercise sessions. The sessions will be scheduled weekly in partnership with a coach. A trained fitness instructor will lead the participants in a 10-minute warm-up, followed by 30 minutes of interval training, and a 10-minute stretching and cool down activity. Intervals will progress in intensity over the course of the 20-week program and progression will be based on individualized target heart rate zones established from baseline exercise testing.
Behavioral: Exercise Training
The Mobility \& Flexibility Training Program focuses on mobility and flexibility. The training will be focused on improving mobility and flexibility through three times a week stretching and mobility program. A 5-minute warm up will be followed by a series of stretches and mobility patterns that will be repeated as a circuit four times. Each session will focus on a specific muscle group - upper body, lower body or core. The classes will be led by a fitness instructor in the same manner as the exercise group with a virtual link sent to the participants.
Behavioral: Mobility and Flexibility Training
The Exercise Training will follow a progressive interval-based training program designed for youth with MS. Participants will engage in three weekly exercise sessions. Participants will be given access to links to live virtual structured exercise sessions. The sessions will be scheduled weekly in partnership with a coach. A trained fitness instructor will lead the participants in a 10-minute warm-up, followed by 30 minutes of interval training, and a 10-minute stretching and cool down activity. Intervals will progress in intensity over the course of the 20-week program and progression will be based on individualized target heart rate zones. The session will be delivered via a live feed in order to foster social support from the participants peers enrolled in the program. Participants will have the option of completing the class in real-time and make up classes will also be available through a repository of sessions accessible through links to the repository cloud.
Also known as: Exercise Program for Youth with MS
The Mobility and Flexibility Training will be focused on improving mobility and flexibility through three times a week stretching and mobility program. A 5-minute warm up will be followed by a series of stretches and mobility patterns that will be repeated as a circuit four times. Each session will focus on a specific muscle group - upper body, lower body or core. The classes will be led by a fitness instructor in the same manner as the exercise intervention arm with a virtual link sent to the participants.
Also known as: Mobility and Flexibility Training Program
Participant accrual rate
Number of participants enrolled per year
Time frame: From enrollment to the end of study
Fidelity of delivering the intervention
ASPIRE fidelity coaching checklist. This measure assesses the fidelity with which study coaches deliver the intervention during calls with participants. Participants are scored on a scale from 0 to 2, based on the extent to which the intervention components are covered: 0: Did not cover - The intervention component was not addressed during the call. 1. Partially covered - The intervention component was addressed to some extent, but not fully. 2. Fully covered - The intervention component was fully addressed, meeting the intended criteria for delivery. A higher score reflects a more complete and accurate delivery of the intervention as planned.
Time frame: From enrollment to the end of intervention at 20 weeks
Participant drop-out rate
Percentage of total patients that dropped out of study.
Time frame: From enrollment to the end of study
Adverse event rate
Number of adverse events per total participants
Time frame: From enrollment to the end of study
Completion rate of study measures
Percentage of total patients that completed the study measures.
Time frame: From enrollment to the end of study
Blood myokine irisin measurement
Change in blood irisin levels (ng/mL) between baseline and end of 20-week intervention.
Time frame: From enrollment to the end of intervention at 20 weeks
Blood brain-derived neurotrophic factor (BDNF) measurement
Change in blood BDNF levels (ng/mL) between baseline and end of 20-week intervention.
Time frame: From enrollment to the end of intervention at 20 weeks
Change in brain volumes
This outcome measure assesses changes in brain volume following the intervention. MRI scans of the brain will be performed at baseline and at 20 weeks. The outcome metrics include the absolute change in brain volume (mm\^3), percentage change in brain volume, and variance in brain volume changes across participants.
Time frame: From enrollment to the end of intervention at 20 weeks
Cognitive flexibility - Dimensional Change Card Sort test
This outcome measure evaluates cognitive performance based on a combination of accuracy and reaction time. The scoring process combines accuracy and reaction time, using a 2-vector system where each vector is scored from 0 to 5. The final score ranges from 0 to 10. If a participant's accuracy is 80% or lower, the final score is based solely on accuracy. If accuracy exceeds 80%, both accuracy and reaction time are combined to calculate the final score. A score below 4 indicates that accuracy was insufficient (lower than or equal to 80%) to allow for a reaction time score. Higher scores are associated with better cognitive flexibility. Normative data are used to compare the participant's performance to age- and education-based averages, providing a contextual understanding of individual scores.
Time frame: From enrollment to the end of intervention at 20 weeks
Executive function (Inhibitory control and attention) - Flanker test
The scoring method for the Flanker test is identical to that of the DCCS and uses a 2-vector scoring system based on accuracy and reaction time, each scored on a scale from 0 to 5. The final computed score ranges from 0 to 10, representing the participant's overall performance. If a participant's accuracy is 80% or lower, the final computed score is based solely on accuracy. If accuracy exceeds 80%, the reaction time score and accuracy score are combined to calculate the final score. A computed score below 4 indicates that the participant did not achieve sufficient accuracy (lower than or equal to 80%) to include a reaction time component. Higher scores reflect better attention and the ability to ignore distractions, indicating stronger cognitive control. Normative data are used to compare the participant's performance to age- and education-based averages, providing a contextual understanding of individual scores.
Time frame: From enrollment to the end of intervention at 20 weeks
Information Processing Speed - Oral Symbol Digit Test (OSD)
The OSD assesses information processing speed, attention, and cognitive efficiency by requiring participants to match numbers with corresponding symbols using a reference key within a 120-seconds time limit. The test is scored based on the total number of correct responses (raw score), with higher scores indicating better performance. Changes in raw scores between Time 1 and Time 2 reflect improvements or declines in cognitive processing speed over time. Normative data are used to compare the participant's performance to age- and education-based averages, providing context for individual scores.
Time frame: From enrollment to the end of intervention at 20 weeks
Free viewing eye tracking - Saccades
This outcome measure evaluates visual attention, cognitive processing, and arousal through key eye-tracking metrics collected during free-viewing tasks. Data are recorded and analyzed to understand participants' visual and cognitive engagement with presented stimuli. The mean saccade rate (MSR) will be calculated as the frequency of macro-saccades (saccades with an amplitude of greater than or equal to 2 degress) across all videos combined.
Time frame: From enrollment to the end of intervention at 20 weeks
Free viewing eye tracking - Fixations
This outcome measure evaluates visual attention, cognitive processing, and arousal through key eye-tracking metrics collected during free-viewing tasks. Data are recorded and analyzed to understand participants' visual and cognitive engagement with presented stimuli.The mean fixation duration (MFD) will be calculated as the average time spent fixating between any two successive saccades across all video clips.
Time frame: From enrollment to the end of intervention at 20 weeks
PedsQL Core Module
This measure evaluates the health-related quality of life (HRQoL) in children and adolescents using the Varni Pediatric Quality of Life Inventory (PedsQL) Core Module. The PedsQL consists of 23 items across four dimensions: Physical, Emotional, Social, and School Functioning. Each item is scored on a 5-point Likert scale, with responses reverse-scored and transformed to a 0-100 scale, where higher scores indicate better HRQoL.
Time frame: From enrollment to the end of intervention at 20 weeks
Varni Pediatric Multidimensional Fatigue Scale (PedsQL-MFS)
The Varni Pediatric Multidimensional Fatigue Scale (PedsQL-MFS) is a tool designed to measure fatigue in children and adolescents, assessing its impact on daily functioning. The scale includes 18 items across three domains: General Fatigue, Sleep/Rest Fatigue, Cognitive Fatigue. Participants rate their level of fatigue over the past month on a 5-point Likert scale, where higher scores indicate less fatigue. Items are reverse-scored and transformed to a 0-100 scale, with higher scores representing less fatigue. Subscale scores are calculated for each dimension, and a total fatigue score is derived by averaging the scores from all three domains.
Time frame: From enrollment to the end of intervention at 20 weeks
The Centre for Epidemiological Studies Depression Scale Children's Rating Scale (CES-DC)
The Centre for Epidemiological Studies Depression Scale Children's Rating Scale (CES-DC) is a widely used tool for assessing depressive symptoms in children and adolescents. The scale consists of 20 items that measure symptoms of depression experienced during the past week. These symptoms are related to mood, behavior, and physical well-being, and include feelings of sadness, irritability, social withdrawal, and changes in sleep or appetite. Each item is rated on a 4-point Likert scale ranging from 0 (Not At All) to 3 (A Lot). The total score is obtained by summing the ratings across all 20 items, with higher scores indicating more severe depressive symptoms.
Time frame: From enrollment to the end of intervention at 20 weeks
Screen for Anxiety-Related Disorders (SCARED)
The Screen for Anxiety-Related Disorders (SCARED) is a self-report tool designed to screen for anxiety symptoms in children and adolescents. The scale consists of 41 items that assess symptoms related to various anxiety disorders, including generalized anxiety disorder, separation anxiety disorder, social anxiety disorder, and specific phobias. Each item is rated on a 3-point Likert scale: 0 (Not true or hardly ever true), 1 (Somewhat true or sometimes true), and 2 (Very true or often true). The total score is derived by summing the ratings across all items, with higher scores indicating more severe anxiety symptoms.
Time frame: From enrollment to the end of intervention at 20 weeks
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
The GLTEQ is a self-report tool used to assess the frequency and intensity of physical activity during leisure time. The GLTEQ consists of three questions that measure the frequency of strenuous, moderate, and light physical activities performed for at least 15 minutes during a typical week. Participants are asked to report the number of times they engage in each level of activity over the past week, using the following intensity categories: Strenuous activity, Moderate activity, and Light activity. Each question is rated on a 4-point scale: 0 (None), 1 (once a week), 2 (twice a week), and 3 (3 or more times a week). The GLTEQ provides a score by multiplying the frequency of each activity level by a corresponding factor (9 for strenuous, 5 for moderate, and 3 for light), and then summing the results. The final score represents the overall level of physical activity, with higher scores indicating greater levels of leisure-time physical activity.
Time frame: From enrollment to the end of intervention at 20 weeks
Plan to share: No
Start is estimated for Jun 2025; primary completion for Sep 2026, 15 months later.
Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 15 months is below that.
Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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