An interventional study of Sub symptom aerobic exercise in Brain Concussion, Pediatric and Mild Traumatic Brain Injury, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-05-04.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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.
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.
550 studies on the registry are indexed under Brain Concussion; 154 are open to participants now.
This study's enrollment of 16 is below the median of 64 across 376 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 319 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Sub symptom aerobic exercise
Participants will continue with their return to play progression based upon the advice given to them at their initial post-injury evaluation.
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.
Change from Baseline in Post Concussion Symptom Inventory
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
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Pediatric 25
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
Change from Baseline in Tampa Scale of Kinesiophobia
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
Change from Baseline in Physical activity level
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
Change from Baseline in Dual-task walking speed
Measure of the the average walking speed of subjects during dual-task conditions (m/s).
Time frame: Baseline (within 1 week of injury), Month 1, Month 2
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2020 to primary completion in Nov 2021, 20 months.
Of 222 non-industry interventional studies with no phase under Brain Concussion, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's 20 months is below that.
Counting every sponsor, half of 236 studies reached it within 28 months; a quarter within 19 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →