Early Exercise to Improve Psychosocial Function After Pediatric Mild Traumatic Brain Injury
Condition: Brain Concussion; Pediatric; Mild Traumatic Brain Injury; Psychological
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Interventional

Summary: 
      The investigators will test the central hypotheses according to the following Specific Aims:

      Aim 1. Determine if an individually prescribed exercise program initiated within the first
      week of mild traumatic brain injury can reduce the risk of developing persistent
      post-concussion symptoms relative to usual care. The investigators hypothesize that the
      exercise group will have a lower risk of developing persistent post-concussion symptoms than
      the usual care group.

      Aim 2. Examine the effect of a two-month exercise program on psycho-social, pain
      interference, and sleep outcomes following mild traumatic brain injury. The investigators
      hypothesize the exercise group will report lower anxiety, depression, and pain interference
      ratings, and higher peer relationship and sleep quality ratings two months of exercise
      following mild traumatic brain injury compared to usual care.
    

Detailed description: 
      The long-term research goal of the proposed study is to develop individualized sub-symptom
      exercise prescriptions for youth who sustain mild traumatic brain injury that can help to
      alleviate mild traumatic brain injury symptoms, reduce the risk of persistent post-concussion
      symptoms, and improve psychosocial outcomes. The overall objectives of this application are
      to prospectively (1) determine if a prescribed exercise program initiated within the first
      week of mild traumatic brain injury can reduce the risk of developing persistent
      post-concussion symptoms and (2) examine the effects of an exercise program on psychosocial,
      sleep, and pain outcomes when initiated within 7 days of injury and continued for two months.
      The investigators will address these objectives by testing the central hypotheses that those
      assigned to an exercise intervention will have lower risk of developing persistent
      post-concussion symptoms and will report lower anxiety, depression, and pain interference
      ratings, higher peer relationship ratings, and better sleep quality ratings compared to usual
      care. In order to achieve this, the investigators will use a block stratified randomized
      intervention design. Block stratified randomization procedures will be conducted according to
      standard procedures so that sample numbers are equally assigned to each group, selected due
      to the relatively small sample size of the proposed study. Participants will be identified,
      enrolled, and assessed within 5 days of mild traumatic brain injury, randomized to an
      exercise intervention or usual care group 3-7 days after mild traumatic brain injury, and
      follow-up with in person assessments at approximately one and two months post-injury.
    

Intervention name(s): Sub symptom aerobic exercise
Intervention type(s): Behavioral
Intervention description(s): Participants will meet with a member of the research team to undergo a bike-based exercise test at the initial test. Heart rate will be obtained at the completion of the test, and intervention participants will be asked to complete exercise at 80% of that level, 5x/week for 20-30 minutes/session over the next two months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Within 1 week of injury, participants will be randomized to either a sub symptom threshold exercise program (intervention group) or usual care (recommendation from their doctor). Those in the intervention group will participate in an exercise program 5x/week, 20-30 minutes/session, for 2 months.
Masking: None (Open Label)
Primary purpose: Treatment