Concussion, Post-concussion Syndrome, Sports Injury
Conditions
Keywords
concussion, mild traumatic brain injury, post-concussion syndrome, adolescents, sports injury, aerobic training, stretching training
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAerobic Training Intervention
BEHAVIORALStretching Intervention
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Adolescents ages 12 to 17 years * Experienced a concussion 4 to 16 weeks prior to enrollment * Experiencing persistent post-concussion symptoms
Exclusion criteria
* Sustained a moderate to severe head injury, head injury more severe than concussion or required an overnight hospital stay * Younger than 12 years of age when beginning the study. * Older than 17 years of age when beginning the study. * Do not live with a parent/guardian. * Injured more than 16 weeks ago. * Do not speak or read English. * Diagnosed with a developmental disability. * Neurological impairment, cognitive disorders, genetic disorders, metabolic disorders, blood disorder, cardiovascular problem/disease, and/or cancer. * Inpatient admission for a psychiatric disorder within the past 12 months. * Taking beta-blockers, anti-depressants, and/or anti-epileptic medications that cannot be discontinued while participating in the study. * Cardiovascular condition that would preclude participation in the training protocol. * Any condition that precludes magnetic resonance imaging (MRI). * Females that are pregnant or become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in post-concussive symptoms at 10 week follow up | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in cognitive functioning at 10 week follow up | 1 year |
Countries
United States
Outcome results
None listed