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Sports-related concussions are common in adolescent-athletes. Prolonged recovery after concussion or post-concussion syndrome (PCS) is a public health problem. This project will determine the effectiveness of an aerobic exercise program for management of PCS and it will evaluate the influence of exercise on biologic correlates of PCS.
Concussion or mild traumatic brain injury (mTBI) is a public health problem and it is imperative that efficacious treatment protocols be developed to reduce the morbidity associated with PCS in adolescents. In adolescent athletes, timely return of normal neurocognitive function and return to sports safely is critical to normal development. The proposed study will fill a critical gap by systematically evaluating the potential efficacy of an aerobic training intervention for management of PCS in adolescents. To our knowledge, this will be the first randomized controlled study to evaluate the efficacy of aerobic training for treatment of PCS in adolescents as soon as four weeks after injury. The study will also improve our understanding of the pathophysiology of PCS and the biologic influence of aerobic training on PCS. The proposed study will fill a critical gap and inform the development of larger studies to assess the efficacy, and if proven efficacious, optimize the timing and intensity of aerobic training treatment protocols, thus transforming the care and limiting the adverse public impact of this condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Training Intervention | Experimental | Children with PCS who are eligible for the study will be randomized to a progressive, sub-symptom exacerbation, cycling aerobic training intervention or stretching comparison intervention. Children with PCS that meet criteria for the intervention trial will complete a baseline evaluation followed by a one week run-in-period (week 0-1) prior to their first intervention visit. After the initial intervention visit, weekly visits will be completed for at least 6 additional weeks (i.e., at least 6 weeks of aerobic training). An individualized home exercise program 5-6 days per week will also be developed. Children will be provided with a home stationary cycle to complete the home program. |
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| Stretching Intervention | Experimental | Children in the stretching intervention will complete a series of full body stretches of the shoulders, arms, chest, back, legs, and feet 5-6 days per week and will return weekly to review the stretching program. The minimum duration of the stretching intervention will also be 6 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Training Intervention | Behavioral |
| ||
| Stretching Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in post-concussive symptoms at 10 week follow up | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in cognitive functioning at 10 week follow up | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brad Kurowski, MD, MS | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31620073 | Derived | Gladstone E, Narad ME, Hussain F, Quatman-Yates CC, Hugentobler J, Wade SL, Gubanich PJ, Kurowski BG. Neurocognitive and Quality of Life Improvements Associated With Aerobic Training for Individuals With Persistent Symptoms After Mild Traumatic Brain Injury: Secondary Outcome Analysis of a Pilot Randomized Clinical Trial. Front Neurol. 2019 Sep 18;10:1002. doi: 10.3389/fneur.2019.01002. eCollection 2019. | |
| 27120294 |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D038223 | Post-Concussion Syndrome |
| D001265 | Athletic Injuries |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Behavioral |
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| Derived |
| Kurowski BG, Hugentobler J, Quatman-Yates C, Taylor J, Gubanich PJ, Altaye M, Wade SL. Aerobic Exercise for Adolescents With Prolonged Symptoms After Mild Traumatic Brain Injury: An Exploratory Randomized Clinical Trial. J Head Trauma Rehabil. 2017 Mar/Apr;32(2):79-89. doi: 10.1097/HTR.0000000000000238. |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |