Exercise for Multiple Sclerosis

(FIT-ATOMIC Trial)

Recruiting at 3 trial locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The Hospital for Sick Children

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 Intervention group or a Mobility and Flexibility Training control 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, MEG/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.

Eligibility Criteria

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.

Inclusion Criteria

A score of 10 or above on the CES-DC scale.

I am between 11 and 25 years old.

I have been diagnosed with MS or had a single MS-like episode.

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)

Are at increased risk of cardiac or other complications of exercise testing, as determined by the pediatric neurologist or physician

Treatment Details

Interventions

• Exercise Training Intervention (Behavioural Intervention)
• Mobility and Flexibility Training (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Exercise Training Intervention Group Active Control 1 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 Group Placebo Group 1 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.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Alberta Health Services, Calgary

Collaborator

Trials

15

Recruited

2,600+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Queen's University

Collaborator

Trials

382

Recruited

122,000+

National Multiple Sclerosis Society

Collaborator

Trials

100

Recruited

10,600+

Multiple Sclerosis Society of Canada

Collaborator

Trials

17

Recruited

990+

Kingston Health Sciences Centre

Collaborator

Trials

312

Recruited

112,000+