FIT-ATOMIC Exercise Feasibility Trial

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• National Multiple Sclerosis Society

  collaborator OTHER

• Multiple Sclerosis Society of Canada

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Alberta Health Services, Calgary

  collaborator OTHER

• Queen's University

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• Unity Health Toronto

  collaborator OTHER

• The Hospital for Sick Children

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-30

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• United States
• Canada

Study Locations