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| ID | Type | Description | Link |
|---|---|---|---|
| ABC | Other Identifier | Children's Health Foundation |
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| Name | Class |
|---|---|
| The University of Texas Health Science Center, Houston | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screen Time Restriction (ST-Restricted) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Greater than 30-days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Health - Andrews Institute | Plano | Texas | 75024 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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. |
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| Aerobic Exercise (AE) | Behavioral | 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. |
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| Screen-time restricted plus aerobic exercise (STR+AE) | Behavioral | 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. |
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| Stretching Only | Behavioral | 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. |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |