To compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18 yo youth with persistent concussion symptoms.
This is a minimal risk randomized controlled trial whose aim is to test the efficacy of an exercise intervention (STEP) for youth 11-18 yo with persistent concussive symptoms (1-6 months inclusive). The investigators are utilizing an active control (light stretching). The primary outcome will be concussion symptoms measured with the Health-Behavior Inventory (HBI) in the first month after randomization. Long-term efficacy will be examined using standardized measures of quality of life and function over 6 months, and potential mediators will be explored including brain derived neurotrophic factor (BDNF), fear-avoidance and physical fitness. Physical activity will be measured with accelerometry to evaluate fidelity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Aerobic exercise program performed below the HR threshold that causes symptoms and administered by an RA using mobile health coaching
Brief daily stretching routine.
Seattle Children's Hospital
Seattle, Washington, United States
Health Behavior Inventory (HBI)
Measure change in concussion symptoms from the baseline evaluation to post-intervention (6 weeks) using HBI.
Time frame: Baseline, Weekly from 1-6 weeks, 3 months, 6 months
PedsQL
Health related quality of life
Time frame: Baseline, 6 weeks, 3 and 6 months
Fear of Pain Questionniare (FOPQ), child and parent
Measure of fear avoidance
Time frame: Trajectory from baseline, 6 weeks, 3 months, 6 months
Moderate-vigorous physical activity (MVPA)
Hip-mounted research grade accelerometry
Time frame: Baseline and 6 weeks
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