Study of an Exercise Program (STEP) for Youth With Concussion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of an Exercise Program (STEP) for Youth With Concussion

Conditions
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Persistent Concussion Symptoms

Intervention / Treatment
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* Behavioral: Subthreshold exercise (STEP) with mobile health coaching
* Behavioral: Light stretching (LS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sports-related concussion that occurred 1-6 months inclusive prior to the start of the study, and was diagnosed by a clinician trained in concussion management consistent with the Zurich definition of concussion (a complex pathophysiological process affecting the brain, induced by biomechanical forces [that] results in a graded set of clinical symptoms that may or may not involve loss of consciousness) Persistent symptoms as defined by the presence of at least 2 concussive symptoms (from the Health Behavior Inventory, or HBI) at the time of recruitment which were not present prior to injury 11 to 18 years of age (inclusive) at time of recruitment Exclusion Criteria: Non-English speaking youth or parents Unwilling or unable to travel to Seattle Children's Hospital or Seattle Children's Research Institute twice during the course of the study Cervical spine or vestibular issues requiring further targeted intervention Other injuries or medical conditions in addition to concussion which would preclude vigorous exercise Psychiatric hospitalization in the year prior to enrollment Significant cognitive deficits such as mental retardation or autism Lack of worsening of concussive symptoms with exertion Significant abnormalities on routine brain imaging.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEP-mhc + LS<br>Subjects will be asked to perform exercise at 80% of the heart rate threshold determined using the Balke protocol for 5 minutes greater than their measured minutes of MVPA/day at baseline (Subthreshold exercise program). They will also be given a light stretching protocol (5 stretches). The exercise intervention will last for 6 weeks and will be supported by weekly health coaching. | Behavioral: Subthreshold exercise (STEP) with mobile health coaching<br>* Aerobic exercise program performed below the HR threshold that causes symptoms and administered by an RA using mobile health coaching<br>Behavioral: Light stretching (LS)<br>* Brief daily stretching routine.<br>|
| Active Comparator: LS alone<br>Subjects will be given a light stretching program alone (5 stretches). The exercise program will last for 6 weeks. | Behavioral: Light stretching (LS)<br>* Brief daily stretching routine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Behavior Inventory (HBI) | Measure change in concussion symptoms from the baseline evaluation to post-intervention (6 weeks) using HBI. | Baseline, Weekly from 1-6 weeks, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PedsQL | Health related quality of life | Baseline, 6 weeks, 3 and 6 months | 
| Fear of Pain Questionniare (FOPQ), child and parent | Measure of fear avoidance | Trajectory from baseline, 6 weeks, 3 months, 6 months | 
| Moderate-vigorous physical activity (MVPA) | Hip-mounted research grade accelerometry | Baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Concussion, mild traumatic brain injury, post concussion syndrome, child