Aerobic Training for Management of Post-Concussion Syndrome in Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT02035579
First received: September 5, 2013
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Concussion
Post-concussion Syndrome
Mild Traumatic Brain Injury
Sports Injury
Behavioral: Aerobic Training Intervention
Behavioral: Stretching Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aerobic Training for Management of Post-Concussion Syndrome in Adolescents

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Change from baseline in post-concussive symptoms at 10 week follow up [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in cognitive functioning at 10 week follow up [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic Training Intervention
Children with PCS who are eligible for the study will be randomized to a progressive, sub-symptom exacerbation, cycling aerobic training intervention or stretching comparison intervention. Children with PCS that meet criteria for the intervention trial will complete a baseline evaluation followed by a one week run-in-period (week 0-1) prior to their first intervention visit. After the initial intervention visit, weekly visits will be completed for at least 6 additional weeks (i.e., at least 6 weeks of aerobic training). An individualized home exercise program 5-6 days per week will also be developed. Children will be provided with a home stationary cycle to complete the home program.
Behavioral: Aerobic Training Intervention
Experimental: Stretching Intervention
Children in the stretching intervention will complete a series of full body stretches of the shoulders, arms, chest, back, legs, and feet 5-6 days per week and will return weekly to review the stretching program. The minimum duration of the stretching intervention will also be 6 weeks
Behavioral: Stretching Intervention

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

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035579

Contacts
Contact: Jennifer Taylor, BS 513-636-7506 jennifer.taylor@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Principal Investigator: Brad Kurowski, MD, MS         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Brad Kurowski, MD, MS Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02035579     History of Changes
Other Study ID Numbers: SPR112665
Study First Received: September 5, 2013
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
concussion
mild traumatic brain injury
post-concussion syndrome
adolescents
sports injury
aerobic training
stretching training

Additional relevant MeSH terms:
Athletic Injuries
Brain Injuries
Syndrome
Post-Concussion Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Disease
Pathologic Processes
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on September 22, 2014