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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02035579
Other study ID # SPR112665
Secondary ID
Status Completed
Phase N/A
First received September 5, 2013
Last updated February 10, 2016
Start date December 2013
Est. completion date May 2015

Study information

Verified date February 2016
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 17 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Aerobic Training Intervention

Stretching Intervention


Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in post-concussive symptoms at 10 week follow up 1 year No
Secondary Change from baseline in cognitive functioning at 10 week follow up 1 year No
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