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Not recruiting

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT04782466

Conditions

Pediatric Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 11 - 21

Healthy Volunteers: Not accepted

Interventions

Physical Activity (PA) Intervention

Waitlist attention-control

Study Details

Brief summary:

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.

Conditions

Pediatric Multiple Sclerosis

Study ID

NCT04782466

Start date

Dec 1, 2020

Status verified date

Mar, 2022

Completion date

Sep, 2023

Anticipated

Primary completion date

Sep, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention

The participant receives the intervention immediately following baseline measurements.

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.

Interventions

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).

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.

Primary outcome measure

  • Physical Activity Level [ Time Frame: Entire study - up to 18 months ]

Central Contacts and Locations

Central contacts

E. Ann Yeh, MA, MD, FRCPC, Dip ABPN

416-813-7654ann.yeh@sickkids.ca

Hareem Ilyas

416-813-7654hareem.ilyas@sickkids.ca

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Brenda Banwell, MD

banwellb@email.chop.edu

Jessica Legaspi

267-426-5092legaspij1@email.chop.edu

Principal Investigator:

Brenda Banwell, MD

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Hareem Ilyas

416-813-7654hareem.ilyas@sickkids.ca

Samantha Stephens, PhD

416-813-7654samantha.stephens@sickkids.ca

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Mar 16, 2022

Last verified

Mar, 2022

Keywords

  • Physical Activity
  • Exercise
  • Multiple Sclerosis
  • Demyelinating Disorders
  • Pediatric
  • Neurology
  • Children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2022-03-16.