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ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program

Aktiv, nicht rekrutierend
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Die klinische Studie NCT04782466 ist eine interventionsstudie zur Untersuchung von Pediatric Multiple Sclerosis und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 1. Dezember 2020 und soll 56 Teilnehmer aufnehmen. Durchgeführt von Hospital for Sick Children ist der Abschluss für 1. September 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 23. September 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.

Offizieller Titel

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

Erkrankungen
Pediatric Multiple Sclerosis
Weitere Studien-IDs
  • 1000065261
  • RG-1901-33188 (Andere Zuwendungs-/Finanzierungsnummer) (National Multiple Sclerosis Society)
NCT-Nummer
Studienbeginn (tatsächlich)
2020-12-01
Zuletzt aktualisiert
2025-09-23
Studienende (vorauss.)
2025-09
Geplante Rekrutierung
56
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Aktiv, nicht rekrutierend
Stichwörter
Physical Activity
Exercise
Multiple Sclerosis
Demyelinating Disorders
Pediatric
Neurology
Children
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellIntervention
The participant receives the intervention immediately following baseline measurements.
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).
AndereWaitlist 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.
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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene
Mindestalter
11 Years
Zugelassene Geschlechter
Alle
  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.

  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.
Verantwortliche Partei
E. Ann Yeh, Hauptprüfer, Senior Associate Scientist, Division of Neuroscience and Mental Health, SickKids Research Institute, The Hospital for Sick Children
Keine Kontaktdaten vorhanden
3 Studienstandorte in 2 Ländern

Alabama

The University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States

Pennsylvania

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States

Ontario

The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada