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Aerobic Training for Management of Post-Concussion Syndrome in Adolescents

Primary Purpose

Concussion, Post-concussion Syndrome, Sports Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Training Intervention
Stretching Intervention
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion focused on measuring concussion, mild traumatic brain injury, post-concussion syndrome, adolescents, sports injury, aerobic training, stretching training

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aerobic Training Intervention

Stretching Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in cognitive functioning at 10 week follow up

Full Information

First Posted
September 5, 2013
Last Updated
February 10, 2016
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT02035579
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Post-concussion Syndrome, Sports Injury
Keywords
concussion, mild traumatic brain injury, post-concussion syndrome, adolescents, sports injury, aerobic training, stretching training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Training Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Stretching Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Training Intervention
Intervention Type
Behavioral
Intervention Name(s)
Stretching Intervention
Primary Outcome Measure Information:
Title
Change from baseline in post-concussive symptoms at 10 week follow up
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change from baseline in cognitive functioning at 10 week follow up
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad Kurowski, MD, MS
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31620073
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.
Results Reference
derived
PubMed Identifier
27120294
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.
Results Reference
derived

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Aerobic Training for Management of Post-Concussion Syndrome in Adolescents

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