Brain ConcussionNCT04199247
Early Exercise to Improve Psychosocial Function After Pediatric Mild Traumatic Brain Injury
A study testing Sub symptom aerobic exercise in people with Brain Concussion and Pediatric, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Brain Concussion, Pediatric, Mild Traumatic Brain Injury
- What is being tested?
- Sub symptom aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2020to 8 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Aged 10 - 18 years to ensure a pediatric sample of participants.
- A persistent postconcussion symptom risk score ≥ 9 to ensure all participants are in the high risk of persistent postconcussion symptom category.
- A Post-Concussion Symptom Inventory score > 9 to ensure participants have not recovered by the time they enroll in the study.
- Access to an internet connection (via computer or smart phone) so that physical activity and exercise can be tracked via heart rate monitor.
Who cannot join
- Concurrent lower extremity injury so that exercise testing results are not confounded by other injury.
- Aerobic exercise contraindication so that participants are able to complete the exercise testing protocol.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Initiation of an Early Exercise Program to Improve Symptoms and Psychosocial Function After Pediatric Mild Traumatic Brain Injury
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.
Read the 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.
- Being tested
- Sub symptom aerobic exercise
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub symptom aerobic exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 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. Receives: Behavioral: Sub symptom aerobic exercise |
| Usual Care | No intervention | Participants will continue with their return to play progression based upon the advice given to them at their initial post-injury evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (within 1 week of injury), Month 1, Month 2
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline (within 1 week of injury), Month 1, Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start20 Feb 2020
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David R Howell, PhD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199247
- Sponsor's protocol ID
- 17-2020
- Status last verified
- May 2022
- First submitted
- 10 Dec 2019
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of an Early Exercise Program to Improve Symptoms and Psychosocial Function After Pediatric Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04199247
- Acronym / sponsor ID
- 17-2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Sub symptom aerobic exerciseWithin 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. |
| Usual Care | No intervention | –Participants will continue with their return to play progression based upon the advice given to them at their initial post-injury evaluation. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
- Aged 10 - 18 years to ensure a pediatric sample of participants.
- A persistent postconcussion symptom risk score ≥ 9 to ensure all participants are in the high risk of persistent postconcussion symptom category.
- A Post-Concussion Symptom Inventory score > 9 to ensure participants have not recovered by the time they enroll in the study.
- Access to an internet connection (via computer or smart phone) so that physical activity and exercise can be tracked via heart rate monitor.
Key exclusion criteria (4 listed)
- Concurrent lower extremity injury so that exercise testing results are not confounded by other injury.
- Aerobic exercise contraindication so that participants are able to complete the exercise testing protocol.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sub symptom aerobic exerciseParticipants 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. | Behavioural | Exercise |
Primary outcome
Change from Baseline in Post Concussion Symptom Inventory
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.
4 secondary outcomes
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Pediatric 25
Time frame: Baseline (within 1 week of injury), Month 1, Month 2
Change from Baseline in Tampa Scale of Kinesiophobia
Time frame: Baseline (within 1 week of injury), Month 1, Month 2
Change from Baseline in Physical activity level
Time frame: Baseline (within 1 week of injury), Month 1, Month 2
Change from Baseline in Dual-task walking speed
Time frame: Baseline (within 1 week of injury), Month 1, Month 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Howell, PhD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub symptom aerobic exercise in people with Brain Concussion and Pediatric, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Post Concussion Symptom Inventory (time frame: Baseline (within 1 week of injury), Month 1, Month 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.