Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Brain Concussion
  • Mild Traumatic Brain Injury
  • Pediatric
  • Psychological
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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

Participation Requirements

Age
Between 10 years and 18 years
Gender
Both males and females

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 psy...

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.

Tracking Information

NCT #
NCT04199247
Collaborators
Not Provided
Investigators
Principal Investigator: David R Howell, PhD Children's Hospital Colorado