Persistent Concussion Symptoms
Conditions
Keywords
Concussion, mild traumatic brain injury, post concussion syndrome, child
Brief summary
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
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.
Interventions
BEHAVIORALSubthreshold exercise (STEP) with mobile health coaching
Aerobic exercise program performed below the HR threshold that causes symptoms and administered by an RA using mobile health coaching
BEHAVIORALLight stretching (LS)
Brief daily stretching routine.
Sponsors
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Behavior Inventory (HBI) | Baseline, Weekly from 1-6 weeks, 3 months, 6 months | Measure change in concussion symptoms from the baseline evaluation to post-intervention (6 weeks) using HBI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PedsQL | Baseline, 6 weeks, 3 and 6 months | Health related quality of life |
| Fear of Pain Questionniare (FOPQ), child and parent | Trajectory from baseline, 6 weeks, 3 months, 6 months | Measure of fear avoidance |
| Moderate-vigorous physical activity (MVPA) | Baseline and 6 weeks | Hip-mounted research grade accelerometry |
Countries
United States
Outcome results
None listed