Children's Hospital Colorado
Aurora, Colorado, 80045, United States
NCT Number: NCT04199247
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.
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Notify Me10 year–18 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline (within 1 week of injury), Month 1, Month 2
Overall symptom severity, rated as a sum score from 0-122. A higher score indicates more severe symptoms, while a 0 indicates that the patient is not experiencing symptoms.
Time frame: Baseline (within 1 week of injury), Month 1, Month 2
A brief generalized quality of life questionnaire. We will calculate the sub-scale scores for the domains of Mobility, Depressive Symptoms, Anxiety, Peer Relationships, and Pain Interference. Each sub-scale is calculated as a sum of 4 questions, rated from 0-4. Thus, each subscale is from 0-16, where a 16 indicates a greater presence of the domain being measured.
Time frame: Baseline (within 1 week of injury), Month 1, Month 2
A brief questionnaire about fear of movement and injury related to returning to sport. The subject answers 18 questions rated from 1 (strongly disagree) to 4 (strongly agree). There is a total sum score ranging form 18-72, where a higher score represents more fear of movement.
Time frame: Baseline (within 1 week of injury), Month 1, Month 2
In order to assess the effect of physical activity level on recovery, we will provide participants with heart-rate activity monitors.
Time frame: Baseline (within 1 week of injury), Month 1, Month 2
Measure of the the average walking speed of subjects during dual-task conditions (m/s).
University of Colorado, Denver
Other
Initiation of an Early Exercise Program to Improve Symptoms and Psychosocial Function After Pediatric Mild Traumatic Brain Injury
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