NCT04199247

Early Exercise to Improve Psychosocial Function After Pediatric Mild Traumatic Brain Injury

Initiation of an Early Exercise Program to Improve Symptoms and Psychosocial Function After Pediatric Mild Traumatic Brain Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Concussion
• Pediatric
• Mild Traumatic Brain Injury
• Psychological

Interventions

Type	Name	Description
BEHAVIORAL	Sub symptom aerobic exercise	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.

Timeline

• Start date: 2020-02-20
• Primary completion: 2021-11-08
• Completion: 2021-11-08
• First posted: 2019-12-13
• Last updated: 2022-05-04

Locations

1 site across 1 country: United States