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Behavioural Intervention
Exercise for Multiple Sclerosis (FIT-ATOMIC Trial)
La Jolla, CA
N/A
Waitlist Available
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Have significant motor disability (EDSS ≥4)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to the end of intervention at 20 weeks
Summary
This trial will test a 20-week exercise program for young people with Multiple Sclerosis. The goal is to see if exercise can help improve the health of those with MS. Participants will be split into
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Who is the study for?
This trial is for young individuals with Multiple Sclerosis. They should be able to perform exercises at home and willing to undergo various assessments, including brain scans and blood tests. Details on specific age or health status requirements are not provided.Check my eligibility
What is being tested?
The study is testing a 20-week home-based exercise program against a control group doing mobility and flexibility training. It aims to see if the exercise program can improve physical activity levels, mental health, cognitive function, and biological markers in youth with MS.See study design
What are the potential side effects?
Since this trial involves exercise interventions rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue. Specific side effects will depend on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 11 and 25 years old.
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I have been diagnosed with MS or had a single MS-like episode.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have significant difficulty with walking or moving.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to the end of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the end of study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse event rate
Completion rate of study measures
Fidelity of delivering the intervention
+2 moreOther study objectives
Blood brain-derived neurotrophic factor (BDNF) measurement
Blood myokine irisin measurement
Change in brain volumes
+10 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Exercise Training Intervention GroupActive Control1 Intervention
The exercise training intervention 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.
Group II: Control GroupPlacebo Group1 Intervention
The Mobility \& Flexibility Training Program is a sham intervention designed to focus on mobility and flexibility. The sham intervention 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.
Find a Location
Closest Location:University of California, San Diego· La Jolla, CA
Who is running the clinical trial?
Alberta Health Services, CalgaryOTHER
14 Previous Clinical Trials
2,564 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
746 Previous Clinical Trials
11,404,727 Total Patients Enrolled
5 Trials studying Multiple Sclerosis
1,529 Patients Enrolled for Multiple Sclerosis
University of California, San DiegoOTHER
1,212 Previous Clinical Trials
1,593,074 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
3,146 Patients Enrolled for Multiple Sclerosis
University of Illinois at ChicagoOTHER
649 Previous Clinical Trials
1,573,377 Total Patients Enrolled
16 Trials studying Multiple Sclerosis
1,819 Patients Enrolled for Multiple Sclerosis
Unity Health TorontoOTHER
570 Previous Clinical Trials
459,728 Total Patients Enrolled
5 Trials studying Multiple Sclerosis
939 Patients Enrolled for Multiple Sclerosis
Queen's UniversityOTHER
381 Previous Clinical Trials
122,719 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
593 Patients Enrolled for Multiple Sclerosis
The Hospital for Sick ChildrenLead Sponsor
721 Previous Clinical Trials
6,966,282 Total Patients Enrolled
7 Trials studying Multiple Sclerosis
319 Patients Enrolled for Multiple Sclerosis
National Multiple Sclerosis SocietyOTHER
99 Previous Clinical Trials
10,564 Total Patients Enrolled
97 Trials studying Multiple Sclerosis
10,210 Patients Enrolled for Multiple Sclerosis
Multiple Sclerosis Society of CanadaOTHER
16 Previous Clinical Trials
947 Total Patients Enrolled
16 Trials studying Multiple Sclerosis
947 Patients Enrolled for Multiple Sclerosis