Sport-related ConcussionNCT05373992
Concussion Screen Use Recovery Time
A study testing Screen Time Restriction (ST-Restricted), Aerobic Exercise (AE) and Screen-time restricted plus aerobic exercise (STR+AE) in people with Sport-related Concussion, run by Children's Health at 1 site in United States.
Trial summary
A two-year parallel randomized clinical trial study to examine the effect of screen time (ST) restriction, exercise alone, and combined ST-restricted-exercise when compared to stretching only (control group) on sports related concussion recovery time among adolescents aged 12 to 17 years. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Sport-related Concussion
- What is being tested?
- Screen Time Restriction (ST-Restricted), Aerobic Exercise (AE) and Screen-time restricted plus aerobic exercise (STR+AE)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 1 Feb 2024
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female subjects
- Age 12-17 years of age presenting to the Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) concussion clinic in Plano, Texas, to be treated for a diagnosed SRC
- Patients who suffered a sport-related concussion within 72-hours of first clinic visit
Who cannot join
- Patients who suffered a sport-related concussion outside of 72-hours of first clinic visit
- Is not diagnosed with a SRC
- Is already taking part in another study that measures their physical activity, sleep, screen-time, or is related to concussion
- Has a current diagnosis of and treatment with medication for attention deficit/hyperactivity disorder, learning disorder, depression, anxiety, or a history of more than 3 prior concussions (because these factors are associated with delayed recovery
- Has a co-existing musculoskeletal injury that may impact their ability to be physically active during recovery
- Has an increased cardiac event risk according to the American College of Sports Medicine criteria
Show all 9Show fewer
- Has a symptom severity score of less than 5 points on the post-concussion symptom scale during the initial clinical examination
- Has an ability to exercise to exhaustion without symptom provocation during the initial clinical examination
- Has limited English language proficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Health - Andrews Institute
Plano, Texas, 75024
About this study
Official title: Effect of Exercise and Restrictions to Screen-time on Sport-related Concussion Recovery Time Among Adolescents
A two-year parallel randomized clinical trial study to examine the effect of screen time (ST) restriction, exercise alone, and combined ST-restricted-exercise when compared to stretching only (control group) on sports related concussion recovery time among adolescents aged 12 to 17 years. Study hypothesis 1 - There will be significant differences between the treatment and the control arms' mean recovery time (days). Study hypothesis 2 - The ST-restricted \& exercise treatment arm will have a significantly shorter mean recovery time (days) compared with the other treatment arms and control arm.
Read the detailed description
The investigators will randomize a sports related concussion (SRC) treatment protocol (n=313) of Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) pediatric SRC patients (aged 12-17 years) to one of four treatment groups:1. Screen Time (ST) restricted group, 2.Exercise group, 3.ST restricted \& exercise group, and Control [stretching only]) group. The treatments will occur for the first 72-hours following the first clinic appointment. The investigators will monitor treatment adherence and 24-hour movement behaviors over a 72-hour period using the ActiGraph GT9X Link and heart rate monitor; a state-of-the-art research grade wearable device that our research team has expertise in administering and analyzing in field-based studies.
- Conditions
- Sport-related Concussion
- Being tested
- Screen Time Restriction (ST-Restricted), Aerobic Exercise (AE), Screen-time restricted plus aerobic exercise (STR+AE), Stretching Only
- Keywords
- Concussion, Sports related head injury
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screen Time Restriction (ST-Restricted)Behavioural
Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) for the first 72-hours following the initial clinic visit. Following the first 72-hours of restricted screen-time, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.
Aerobic Exercise (AE)Behavioural
Engage in 30-minutes of aerobic exercise daily for the first 72-hours following the initial clinic visit in the form of a stationary exercise bike, treadmill, or outdoors. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate (HR). Following the first 72-hours of prescribed AE, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.
Screen-time restricted plus aerobic exercise (STR+AE)Behavioural
Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) while concurrently engaging in daily aerobic exercise in the form of a stationary exercise bike, treadmill, or outdoors, for the first 72-hours following the initial clinic visit. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate (HR). Following the first 72-hours of prescribed STR+AE, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.
Stretching OnlyBehavioural
Participants will be instructed to follow a prescribed stretching program for the first 72-hours following the initial clinic visit. Following the first 72-hours of prescribed stretching, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Screen Time Restricted | Experimental | Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) for the first 72-hours following the initial clinic visit. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity. Receives: Behavioral: Screen Time Restriction (ST-Restricted) |
| Aerobic Exercise | Experimental | Participants will be asked to engage in 30-minutes of aerobic exercise (AE) daily for the first 72-hours following the initial clinic visit in the form of a stationary exercise bike, treadmill, or outdoors. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity. Receives: Behavioral: Aerobic Exercise (AE) |
| Screen Time Restricted & Aerobic Exercise | Experimental | Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) as well as engage in 30-minutes of AE in the form of a stationary exercise bike, treadmill, or outdoors, for the first 72-hours following the initial clinic visit. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity. Receives: Behavioral: Screen-time restricted plus aerobic exercise (STR+AE) |
| Stretching | Active comparator | Participants will be asked to follow a daily stretching program for the first 72-hours following the initial clinic visit. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity. Receives: Behavioral: Stretching Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery Time
Primary outcome is recovery time (days) as measured as the number of days between the date of injury and day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities, which must occur for at least three consecutive days.
Measured: Day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities
Secondary outcomes (1)
Protracted recovery
Secondary outcome is protracted recovery. A positive classification for protracted recovery is defined as a recovery time, as specified previously, greater than 30-days.
Measured: Greater than 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Jul 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport-related ConcussionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Health
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, John Abt, PhD, Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373992
- Sponsor's protocol ID
- STU-2022-0150
- Other IDs
- ABC
- Status last verified
- Sep 2023
- First submitted
- 10 May 2022
- Last updated
- 18 Oct 2024
- 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 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise and Restrictions to Screen-time on Sport-related Concussion Recovery Time Among Adolescents
- ClinicalTrials.gov ID
- NCT05373992
- Acronym / sponsor ID
- STU-2022-0150
- Conditions
- Sport-related Concussion
- Keywords
- Concussion, Sports related head injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Children's HealthUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 13 May 2022 (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.
A two-year parallel randomized clinical trial study to examine the effect of screen time (ST) restriction, exercise alone, and combined ST-restricted-exercise when compared to stretching only (control group) on sports related concussion recovery time among adolescents aged 12 to 17 years. Study hypothesis 1 - There will be significant differences between the treatment and the control arms' mean recovery time (days). Study hypothesis 2 - The ST-restricted \& exercise treatment arm will have a significantly shorter mean recovery time (days) compared with the other treatment arms and control arm.
Detailed description
The investigators will randomize a sports related concussion (SRC) treatment protocol (n=313) of Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) pediatric SRC patients (aged 12-17 years) to one of four treatment groups:1. Screen Time (ST) restricted group, 2.Exercise group, 3.ST restricted \& exercise group, and Control [stretching only]) group. The treatments will occur for the first 72-hours following the first clinic appointment. The investigators will monitor treatment adherence and 24-hour movement behaviors over a 72-hour period using the ActiGraph GT9X Link and heart rate monitor; a state-of-the-art research grade wearable device that our research team has expertise in administering and analyzing in field-based studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Screen Time Restricted | Experimental | Behavioral: Screen Time Restriction (ST-Restricted)Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) for the first 72-hours following the initial clinic visit. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity. |
| Aerobic Exercise | Experimental | Behavioral: Aerobic Exercise (AE)Participants will be asked to engage in 30-minutes of aerobic exercise (AE) daily for the first 72-hours following the initial clinic visit in the form of a stationary exercise bike, treadmill, or outdoors. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity. |
| Screen Time Restricted & Aerobic Exercise | Experimental | Behavioral: Screen-time restricted plus aerobic exercise (STR+AE)Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) as well as engage in 30-minutes of AE in the form of a stationary exercise bike, treadmill, or outdoors, for the first 72-hours following the initial clinic visit. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity. |
| Stretching | Active comparator | Behavioral: Stretching OnlyParticipants will be asked to follow a daily stretching program for the first 72-hours following the initial clinic visit. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female subjects
- Age 12-17 years of age presenting to the Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) concussion clinic in Plano, Texas, to be treated for a diagnosed SRC
- Patients who suffered a sport-related concussion within 72-hours of first clinic visit
Key exclusion criteria (9 listed)
- Patients who suffered a sport-related concussion outside of 72-hours of first clinic visit
- Is not diagnosed with a SRC
- Is already taking part in another study that measures their physical activity, sleep, screen-time, or is related to concussion
- Has a current diagnosis of and treatment with medication for attention deficit/hyperactivity disorder, learning disorder, depression, anxiety, or a history of more than 3 prior concussions (because these factors are associated with delayed recovery
- Has a co-existing musculoskeletal injury that may impact their ability to be physically active during recovery
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 |
|---|---|---|
| Screen Time Restriction (ST-Restricted)Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) for the first 72-hours following the initial clinic visit. Following the first 72-hours of restricted screen-time, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity. | Behavioural | Screen Time Restricted |
| Aerobic Exercise (AE)Engage in 30-minutes of aerobic exercise daily for the first 72-hours following the initial clinic visit in the form of a stationary exercise bike, treadmill, or outdoors. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate (HR). Following the first 72-hours of prescribed AE, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity. | Behavioural | Aerobic Exercise |
| Screen-time restricted plus aerobic exercise (STR+AE)Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) while concurrently engaging in daily aerobic exercise in the form of a stationary exercise bike, treadmill, or outdoors, for the first 72-hours following the initial clinic visit. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate (HR). Following the first 72-hours of prescribed STR+AE, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity. | Behavioural | Screen Time Restricted & Aerobic Exercise |
| Stretching OnlyParticipants will be instructed to follow a prescribed stretching program for the first 72-hours following the initial clinic visit. Following the first 72-hours of prescribed stretching, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity. | Behavioural | Stretching |
Primary outcome
Recovery Time
Time frame: Day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities
Primary outcome is recovery time (days) as measured as the number of days between the date of injury and day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities, which must occur for at least three consecutive days.
1 secondary outcome
Protracted recovery
Time frame: Greater than 30-days
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 18 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screen Time Restriction (ST-Restricted), Aerobic Exercise (AE) and Screen-time restricted plus aerobic exercise (STR+AE) in people with Sport-related Concussion, run by Children's Health 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 3 inclusion and 9 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 18 Oct 2024. 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?
Recovery Time (time frame: Day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities). 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 18 Oct 2024.