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

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04199247
• Other study ID #: 17-2020
• Status: Completed
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: November 8, 2021

Study information

• Verified date: May 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Concussion or mTBI diagnosis by a board-certified Sports Medicine physician, pediatric Emergency Medicine physician, general pediatrician physician, or advanced practice provider under the direction of a physician. This will be defined in a similar manner according to available guidelines: a direct or indirect blow to the head, face, neck, or elsewhere that manifests with the presence of symptoms and neurological impairment

2. Aged 10 - 18 years to ensure a pediatric sample of participants.

3. A persistent postconcussion symptom risk score = 9 to ensure all participants are in the high risk of persistent postconcussion symptom category.

4. A Post-Concussion Symptom Inventory score > 9 to ensure participants have not recovered by the time they enroll in the study.

5. Access to an internet connection (via computer or smart phone) so that physical activity and exercise can be tracked via heart rate monitor.

Exclusion Criteria:

1. Concurrent lower extremity injury so that exercise testing results are not confounded by other injury.

2. Aerobic exercise contraindication so that participants are able to complete the exercise testing protocol.

3. Diagnosed mild traumatic brain injury by a healthcare provider within 6 months of qualifying injury to ensure that residual effects of prior mild traumatic brain injury do not bias the results of our investigation.

4. Mild traumatic brain injury that results in positive findings on neuroimaging, or extra-axial or intraparenchymal bleeds to avoid potential injuries that are more severe than mild traumatic brain injury.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Pediatric
• Psychological
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (within 1 week of injury), Month 1, Month 2
Secondary	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.	Baseline (within 1 week of injury), Month 1, Month 2
Secondary	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.	Baseline (within 1 week of injury), Month 1, Month 2
Secondary	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.	Baseline (within 1 week of injury), Month 1, Month 2
Secondary	Change from Baseline in Dual-task walking speed	Measure of the the average walking speed of subjects during dual-task conditions (m/s).	Baseline (within 1 week of injury), Month 1, Month 2