Clinical trial NCT03691363: Mobile Subthreshold Exercise Program for Concussion
Official title: Mobile Subthreshold Exercise Program (M-STEP) for Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Keywords: child
Adolescent
exercise
rehabilitation
physical activity
virtual
mobile health
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 19
Sex: ALL
Minimum age (years): 9
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All youth will receive the intervention
Primary purpose: TREATMENT

Brief summary: Non-randomized pilot intervention using mobile-administered sub-threshold exercise to treat youth with prolonged symptoms of concussion.

Detailed description: 6-week pilot study of a novel intervention for concussion, administering a sub-threshold exercise program in a mobile fashion using video conferencing and providing feedback using wrist-worn accelerometry and heart rate monitoring.

Eligibility criteria: Inclusion Criteria:

* Concussion diagnosed by a healthcare provider that occurred 2 weeks-6 months ago
* Continued symptoms with at least 3 symptoms on the HBI and a score of 20+
* No other issues that would preclude physical activity
* Parents and youth are English-speaking

Exclusion Criteria:

- Already participating in \>30 minutes of MVPA/day

Primary outcomes:
measure: Change in Health Behavior Inventory (HBI), 21 item 0-3 likert, higher scores indicate more severe symptoms
timeFrame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Secondary outcomes:
measure: Change in Pediatric Quality of Life Inventory (PedsQL), 23 item 0-4 likert, converted to a 0-100 scale, higher scores indicate improved function
timeFrame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
measure: Change in Fear of pain questionnaire (FOPQ)-P/C, adapted for concussion, 24 item (child) and 23 item (parent) 0-4 likert, higher scores indicate greater fear-avoidance
timeFrame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
measure: Change in Patient Health Questionnaire 9 (PHQ-9), 9 item 0-3 likert, higher scores indicate greater symptoms
timeFrame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
measure: Change in Adolescent Sleep Wake Scale (ASWS), 10-item 0-5 likert, higher scores indicate improved sleep quality
timeFrame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
measure: Change in Generalized anxiety disorder--7 item (GAD7), 7-item 0-3 likert, higher scores indicate more severe symptoms
timeFrame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
measure: Study Satisfaction Questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Sara PD Chrisman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chrisman SPD, Mendoza JA, Zhou C, Palermo TM, Gogue-Garcia T, Janz KF, Rivara FP. Pilot Study of Telehealth Delivered Rehabilitative Exercise for Youth With Concussion: The Mobile Subthreshold Exercise Program (MSTEP). Front Pediatr. 2021 May 28;9:645814. doi: 10.3389/fped.2021.645814. eCollection 2021.