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Completed

NCT Number: NCT02035579

Aerobic Training for Management of Post-Concussion Syndrome in Adolescents

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Training Intervention

Behavioral

Stretching Intervention

Behavioral

Primary outcomes

  1. Change from baseline in post-concussive symptoms at 10 week follow up

    Time frame: 1 year

Secondary outcomes

  1. Change from baseline in cognitive functioning at 10 week follow up

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2014
Registry last updated
Feb 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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