Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-06-30
2026-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Exercise Training Group
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.
Exercise 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.
Mobility & Flexibility Training Group
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.
Mobility and Flexibility Training
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.
Interventions
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Exercise 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.
Mobility and Flexibility Training
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
11 Years
25 Years
ALL
No
Sponsors
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National Multiple Sclerosis Society
OTHER
Multiple Sclerosis Society of Canada
OTHER
University of California, San Diego
OTHER
Children's Hospital of Philadelphia
OTHER
Alberta Health Services, Calgary
OTHER
Queen's University
OTHER
University of Illinois at Chicago
OTHER
Unity Health Toronto
OTHER
The Hospital for Sick Children
OTHER
Responsible Party
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E. Ann Yeh
Staff Neurologist
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.
Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
Krupp LB, Banwell B, Tenembaum S; International Pediatric MS Study Group. Consensus definitions proposed for pediatric multiple sclerosis and related disorders. Neurology. 2007 Apr 17;68(16 Suppl 2):S7-12. doi: 10.1212/01.wnl.0000259422.44235.a8.
Stephens S, Schneiderman JE, Finlayson M, Berenbaum T, Motl RW, Yeh EA. Feasibility of a theory-informed mobile app for changing physical activity in youth with multiple sclerosis. Mult Scler Relat Disord. 2022 Feb;58:103467. doi: 10.1016/j.msard.2021.103467. Epub 2021 Dec 20.
Motl RW, Backus D, Neal WN, Cutter G, Palmer L, McBurney R, Schmidt H, Bethoux F, Hebert J, Ng A, McCully KK, Plummer P. Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis. Contemp Clin Trials. 2019 Jun;81:110-122. doi: 10.1016/j.cct.2019.04.013. Epub 2019 Apr 22.
Stephens S, Berenbaum T, Finlayson M, Motl RW, Yeh EA. Youth with multiple sclerosis have low levels of fitness. Mult Scler. 2021 Sep;27(10):1597-1605. doi: 10.1177/1352458520974360. Epub 2020 Nov 27.
Bilek F, Cetisli-Korkmaz N, Ercan Z, Deniz G, Demir CF. Aerobic exercise increases irisin serum levels and improves depression and fatigue in patients with relapsing remitting multiple sclerosis: A randomized controlled trial. Mult Scler Relat Disord. 2022 May;61:103742. doi: 10.1016/j.msard.2022.103742. Epub 2022 Mar 15.
Spalletta G, Piras F, Caltagirone C, Fagioli S. Hippocampal multimodal structural changes and subclinical depression in healthy individuals. J Affect Disord. 2014 Jan;152-154:105-12. doi: 10.1016/j.jad.2013.05.068. Epub 2013 Jun 22.
Nabkasorn C, Miyai N, Sootmongkol A, Junprasert S, Yamamoto H, Arita M, Miyashita K. Effects of physical exercise on depression, neuroendocrine stress hormones and physiological fitness in adolescent females with depressive symptoms. Eur J Public Health. 2006 Apr;16(2):179-84. doi: 10.1093/eurpub/cki159. Epub 2005 Aug 26.
Wrann CD, White JP, Salogiannnis J, Laznik-Bogoslavski D, Wu J, Ma D, Lin JD, Greenberg ME, Spiegelman BM. Exercise induces hippocampal BDNF through a PGC-1alpha/FNDC5 pathway. Cell Metab. 2013 Nov 5;18(5):649-59. doi: 10.1016/j.cmet.2013.09.008. Epub 2013 Oct 10.
Cotman CW, Berchtold NC, Christie LA. Exercise builds brain health: key roles of growth factor cascades and inflammation. Trends Neurosci. 2007 Sep;30(9):464-72. doi: 10.1016/j.tins.2007.06.011. Epub 2007 Aug 31.
Erickson KI, Voss MW, Prakash RS, Basak C, Szabo A, Chaddock L, Kim JS, Heo S, Alves H, White SM, Wojcicki TR, Mailey E, Vieira VJ, Martin SA, Pence BD, Woods JA, McAuley E, Kramer AF. Exercise training increases size of hippocampus and improves memory. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3017-22. doi: 10.1073/pnas.1015950108. Epub 2011 Jan 31.
Parrish JB, Weinstock-Guttman B, Smerbeck A, Benedict RH, Yeh EA. Fatigue and depression in children with demyelinating disorders. J Child Neurol. 2013 Jun;28(6):713-8. doi: 10.1177/0883073812450750. Epub 2012 Jul 17.
Longoni G, Brown RA, Aubert-Broche B, Grover SA, Branson HM, Fetco D, Bar-Or A, Marrie RA, Motl RW, Collins DL, Narayanan S, Arnold DL, Banwell B, Yeh EA. Physical activity and dentate gyrus volume in pediatric acquired demyelinating syndromes. Neurol Neuroimmunol Neuroinflamm. 2018 Sep 6;5(6):e499. doi: 10.1212/NXI.0000000000000499. eCollection 2018 Nov.
Grover SA, Sawicki CP, Kinnett-Hopkins D, Finlayson M, Schneiderman JE, Banwell B, Till C, Motl RW, Yeh EA. Physical Activity and Its Correlates in Youth with Multiple Sclerosis. J Pediatr. 2016 Dec;179:197-203.e2. doi: 10.1016/j.jpeds.2016.08.104. Epub 2016 Oct 4.
Stephens S, Shams S, Lee J, Grover SA, Longoni G, Berenbaum T, Finlayson M, Motl RW, Yeh EA. Benefits of Physical Activity for Depression and Fatigue in Multiple Sclerosis: A Longitudinal Analysis. J Pediatr. 2019 Jun;209:226-232.e2. doi: 10.1016/j.jpeds.2019.01.040. Epub 2019 Mar 14.
Other Identifiers
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1000080992
Identifier Type: -
Identifier Source: org_study_id
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