FIT-ATOMIC Exercise Feasibility Trial

NCT06870968 | Not Yet Recruiting

• 1 other identifier: 1000080992
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (5)

• Participant accrual rate

  Number of participants enrolled per year

  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.

  From enrollment to the end of intervention at 20 weeks

• Participant drop-out rate

  Percentage of total patients that dropped out of study.

  From enrollment to the end of study

• Adverse event rate

  Number of adverse events per total participants

  From enrollment to the end of study

• Completion rate of study measures

  Percentage of total patients that completed the study measures.

  From enrollment to the end of study

Other Outcomes (13)

• Blood myokine irisin measurement

  From enrollment to the end of intervention at 20 weeks

• Blood brain-derived neurotrophic factor (BDNF) measurement

  From enrollment to the end of intervention at 20 weeks

• Change in brain volumes

  From enrollment to the end of intervention at 20 weeks

Study Arms (2)

Exercise Training Group

ACTIVE COMPARATOR

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

Mobility & Flexibility Training Group

SHAM COMPARATOR

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

Interventions

Exercise Training BEHAVIORAL

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

Exercise Training Group

Mobility and Flexibility Training BEHAVIORAL

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

Mobility & Flexibility Training Group

Eligibility Criteria

• Age: 11 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• National Multiple Sclerosis Society: collaborator
• Multiple Sclerosis Society of Canada: collaborator
• University of California, San Diego: collaborator
• Children's Hospital of Philadelphia: collaborator
• Alberta Health Services, Calgary: collaborator
• Queen's University: collaborator
• University of Illinois at Chicago: collaborator
• Unity Health Toronto: collaborator

Study Sites (4)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (16)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Neuroinflammatory Diseases; Multiple Sclerosis; Motor Activity; Depression; Psychological Well-Being

Interventions

Exercise; Range of Motion, Articular

Condition Hierarchy (Ancestors)

Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Behavioral Symptoms; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Ann Yeh, MD

CONTACT

416-813-7353; ann.yeh@sickkids.ca

Jesse Joynt, MSc

CONTACT

416-813-7654 X415125; jesse.joynt@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: To avoid bias or influence in outcomes, participants will not be informed which training group is the intervention group and which is the sham/control group.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Neurologist

Model Details: Participants will be randomized at the time of enrolment to either an Exercise Training group or a Mobility and Flexibility Training group.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: March 11, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 21, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (2)