Clinical trial NCT04782466: ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program
Official title: Physical Activity, Quality of Life and Disease Outcomes in Youth With Multiple Sclerosis: the ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Multiple Sclerosis
Keywords: Physical Activity
Exercise
Multiple Sclerosis
Demyelinating Disorders
Pediatric
Neurology
Children
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: University of Alabama at Birmingham
name: Queen's University
name: National Multiple Sclerosis Society
First posted: 2021-03-04
Enrollment: 56
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At baseline, participants will be randomized using online research randomizer software, in blocks of 2 each, balanced for the clinical site, sex, and pubertal status (using self-selected Tanner staging), which may independently predict physical fitness level and has also been associated with physical activity level especially in adolescent girls to either a 6-month PA intervention or waitlist attention-control condition. The research coordinator will request the randomization of the participant as provided by the online research randomizer at the completion of the baseline test and will inform the study participant of their assigned study arm.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical Activity Level
timeFrame: Entire study - up to 18 months
Secondary outcomes:
measure: Aerobic Capacity
timeFrame: Entire study - up to 18 months
measure: Self-Reported PA Outcomes
timeFrame: Entire study - up to 18 months
measure: Social Cognitive Theory Based Mediators of Physical Activity
timeFrame: Entire study - up to 18 months
Other outcomes:
measure: Tertiary Outcome Measures: Depression
timeFrame: Entire study - up to 18 months
measure: Tertiary Outcome Measures: Quality of Life
timeFrame: Entire study - up to 18 months
measure: Tertiary Outcome Measures: Fatigue
timeFrame: Entire study - up to 18 months
measure: Tertiary Outcome Measures: Cognitive Function
timeFrame: Entire study - up to 18 months
measure: Tertiary Outcome Measures: Anxiety
timeFrame: Entire study - up to 18 months
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: E. Ann Yeh, MA, MD, FRCPC, Dip ABPN
role: PRINCIPAL_INVESTIGATOR
References: