Concussion Clinical Trial
Official title:
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03304327 -
Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)
|
N/A | |
Completed |
NCT05562544 -
EEG Diagnostic for Repetitive Sub-concussive Head Impacts
|
||
Terminated |
NCT02988609 -
Concussion in Rugby Players: a Pilot Study of Neural Recovery Using fMRI
|
N/A | |
Completed |
NCT02710123 -
Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion
|
N/A | |
Terminated |
NCT02100150 -
A Safety and Efficacy Study of NNZ-2566 in Patients With Mild Traumatic Brain Injury (mTBI)
|
Phase 2 | |
Active, not recruiting |
NCT01874847 -
PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin
|
Phase 2/Phase 3 | |
Completed |
NCT01903525 -
DHA For The Treatment of Pediatric Concussion Related to Sports Injury
|
Phase 1 | |
Completed |
NCT02262507 -
Concussion Device Audiological Measures
|
N/A | |
Enrolling by invitation |
NCT05948501 -
The Effects of Concussion on Gait and Posture in Individuals With Peripheral Vision Loss
|
||
Withdrawn |
NCT02643836 -
Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome
|
N/A | |
Recruiting |
NCT03360786 -
Primary Prevention of Concussion in Youth Ice Hockey Players
|
N/A | |
Recruiting |
NCT03710109 -
Evaluation of an EEG Based Concussion System
|
||
Not yet recruiting |
NCT02930395 -
Blood Biomarkers for the Management of Concussion in Professional Rugby Players
|
N/A | |
Completed |
NCT02271451 -
Q-collar and Brain Injury Biomarkers
|
N/A | |
Completed |
NCT02268240 -
Care for Post-Concussive Symptoms
|
N/A | |
Completed |
NCT02278029 -
Driving Performance of Teenage Patients With mTBI: a Longitudinal Assessment
|
N/A | |
Completed |
NCT02268058 -
Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children
|
N/A | |
Active, not recruiting |
NCT03608722 -
Video Games to Track Cognitive Health
|
N/A | |
Completed |
NCT02556177 -
Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
|
N/A | |
Completed |
NCT02660164 -
A Study to Assess the Effectiveness of the Nautilus BrainPulseâ„¢ as an Aid in the Diagnosis of Concussion
|