ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program

Physical Activity, Quality of Life and Disease Outcomes in Youth With Multiple Sclerosis: the ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program

The investigators have previously shown that youth with MS are very inactive, and that vigorous physical activity is associated with higher levels of well-being and lower MS disease activity in youth. Yet, no effective physical activity interventions have been developed for youth with MS to date. The investigators have taken input from youth with MS to create a Smartphone-based app (the ATOMIC - Active Teens with Multiple Sclerosis - App) that provides tailored physical activity information and coaching, provides tools to increase social connectedness, and promotes physical activity. This proposed research will therefore address the problem of inactivity in youth with MS by studying an intervention to increase physical activity.

Study Overview

• Status: Active, not recruiting
• Conditions: Pediatric Multiple Sclerosis
• Intervention / Treatment: Behavioral: Physical Activity (PA) Intervention; Behavioral: Waitlist attention-control

Detailed Description

Youth with MS have highly active disease and report high levels of fatigue and depression. As MS is a lifetime diagnosis, amelioration of these outcomes may have a sustained and important effect on the lives of these youth. Effective interventions oriented towards improving these outcomes are therefore imperative to develop and study. Importantly, recent work suggests that increased PA has the potential to improve brain tissue integrity, re-myelination, mental health outcomes, and quality of life in youth with MS. The investigators have demonstrated associations between lower levels of PA and higher levels of depressive symptoms and fatigue in these youth over time. Furthermore, the investigators have demonstrated an association between higher levels of PA and lower levels of disease activity in youth with MS. Importantly, preliminary work by the investigators shows that youth with MS have very low levels of PA. Increasing PA, therefore, has the potential to have both disease-modifying and psychosocial benefits in youth with MS.

The investigators have developed a user-driven app and program, the ATOMIC intervention, which addresses barriers to PA participation the investigators previously identified. The program provides youth with tools to increase goal setting, PA self-efficacy, and knowledge, and is embedded in a youth-focused app that is supported by health coaches. Notably, in preliminary work, the investigators have found the ATOMIC program to be acceptable to youth, and furthermore, that it was associated with a 31% increase in physical activity.

These strong preliminary results support moving forward with this proposed research, a multi-center randomized wait-list controlled trial (RCT) of the ATOMIC mobile app and coaching-based physical activity (PA) intervention in youth with multiple sclerosis (MS). The proposed study will examine the extent to which the intervention can change PA levels in this cohort. Additional goals will be to evaluate the effect of the ATOMIC intervention on behavioural change mediators, fitness, and psychosocial outcomes.

For this study, the investigators will recruit 56 youth with MS followed at three tertiary children's hospitals with large, established pediatric MS programs: The Hospital for Sick Children, Children's Hospital of Philadelphia, and the University of Alabama at Birmingham.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingham
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Youth 11-21 years of age;
2. MS diagnosis or clinically isolated syndrome, as per revised McDonald diagnostic criteria and International Pediatric MS Study Group criteria prior to the age of 18;
3. Participating in less than three hours of structured physical activity per week.

Exclusion Criteria:

1. Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities;
2. Do not speak and read English at a level needed to complete the questionnaires (4th grade level);
3. Have significant motor disability, classified as an Expanded Disability Status Scale (EDSS) ≥4;
4. Are at increased risk of cardiac or other complications of exercise testing (e.g. cardiac disease, diabetes), as determined by the pediatric neurologist or physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The participant receives the intervention immediately following baseline measurements.	Behavioral: Physical Activity (PA) Intervention; The ATOMIC intervention consists of four primary components: one-on-one chats with a PA coach, informational posts, PA self-monitoring through an activity tracker and educational modules regarding different aspects of becoming PA delivered through the MS-specific PA app. An overarching goal of moving youth with MS towards meeting current Moderate to Vigorous Physical Activity (MVPA) recommendations will be used in addition to initial results from accelerometer monitoring and evaluation of current PA intentions to establish step goals, with planned weekly incremental increases (10% weekly to goal).
Other: Waitlist attention-control; The participant receives the control condition for 6 months following baseline measurements. After 6 months, the baseline measurements are repeated and then the participant receives the intervention.	Behavioral: Waitlist attention-control; For a period of 6-months, participants will receive the control conditions that involve contact from study personnel and a nutritional educational module to ensure equivalent social contact in both arms of the study. After the 6-months, participants will receive the same intervention as the intervention arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Level	Accelerometry is a valid device-based physical activity measurement tool that will be used to determine physical activity. Children will be asked to wear the accelerometer daily for a week, and the investigators will analyze cases that have four or more days of data with ≥10 hours of wear time per day. The investigators will process the accelerometer data and use step counts as well as validated cut-offs to determine time spent in sedentary, light, and Moderate to Vigorous Physical Activity (MVPA) (minutes/day). The focus of the investigators will be to determine the effect of the ATOMIC intervention on device-measured physical activity levels.	Entire study - up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic Capacity	The investigators will determine cardiorespiratory fitness by measuring peak oxygen uptake (VO2Peak) using a maximal exercise test on a cycle ergometer.	Entire study - up to 18 months
Self-Reported PA Outcomes	The Godin Leisure-Time Exercise Questionnaire (GLTEQ) will be used to self-report physical activity outcomes. This self-report 7-day activity recall scale has been validated in the pediatric population and in the pediatric MS population.	Entire study - up to 18 months
Social Cognitive Theory Based Mediators of Physical Activity	This is a composite set of questionnaires used to evaluate Social Cognitive Theory (SCT) based mediator. The focus of the investigators will be to determine the effect of the intervention on social cognitive theory mediators of PA.	Entire study - up to 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tertiary Outcome Measures: Depression	The Centre for Epidemiological Studies Depression Scale Children's Rating Scale (CES-DC) is a valid and reliable 20-item, self-rated, symptom-oriented scale suitable for people aged six to 23.	Entire study - up to 18 months
Tertiary Outcome Measures: Quality of Life	The Varni Pediatric Quality of Life Inventory - Core Module (PedsQL) is a 23-item scale that measures social, physical, emotional, school functioning quality of life that has been shown to be a valid and reliable measure of quality of life in children with chronic conditions.	Entire study - up to 18 months
Tertiary Outcome Measures: Fatigue	The Varni Pediatric Multidimensional Fatigue Scale (PedsQL-MFS) is a validated and reliable 18-item, self-rated (parent and self-report), symptom-oriented scale suitable for youths aged 8 to 18 that includes fatigue subscales (general, sleep/rest and cognitive fatigue).	Entire study - up to 18 months
Tertiary Outcome Measures: Cognitive Function	The Symbol Digit Modalities Test (SDMT) is a widely used, validated paper and pencil neurocognitive test which assesses processing speed (i.e. the speed of thinking). It validated and used widely in pediatric multiple sclerosis.	Entire study - up to 18 months
Tertiary Outcome Measures: Anxiety	The Screen for Anxiety Related Disorders (SCARED) scale is a validated and reliable 41-item, self-rated, symptom score suitable for youths ages 9 to 18.	Entire study - up to 18 months

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Children's Hospital of Philadelphia; University of Alabama at Birmingham; Queen's University; National Multiple Sclerosis Society
• Investigators: Principal Investigator: E. Ann Yeh, MA, MD, FRCPC, Dip ABPN, The Hospital for Sick Children

Publications and helpful links

Helpful Links

• Neuroinflammatory Disorders Program Research Website

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Physical Activity; Exercise; Children; Pediatric; Neurology; Demyelinating Disorders
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Behavior; Multiple Sclerosis; Demyelinating Diseases; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques; Exercise; Methods
• Other Study ID Numbers: 1000065261; RG-1901-33188 (Other Grant/Funding Number: National Multiple Sclerosis Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No