Clinical trial NCT02035579: Aerobic Training for Management of Post-Concussion Syndrome in Adolescents
Official title: Aerobic Training for Management of Post-Concussion Syndrome in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion
Post-concussion Syndrome
Sports Injury
Keywords: concussion
mild traumatic brain injury
post-concussion syndrome
adolescents
sports injury
aerobic training
stretching training
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in post-concussive symptoms at 10 week follow up
timeFrame: 1 year
Secondary outcomes:
measure: Change from baseline in cognitive functioning at 10 week follow up
timeFrame: 1 year
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Brad Kurowski, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.