Aerobic Training for Management of Post-Concussion Syndrome in Adolescents

NCT02035579 | Completed

• 1 other identifier: SPR112665
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion; Post-concussion Syndrome; Sports Injury

Keywords

concussion; mild traumatic brain injury; post-concussion syndrome; adolescents; sports injury; aerobic training; stretching training

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

• Change from baseline in cognitive functioning at 10 week follow up

  1 year

Study Arms (2)

Aerobic Training Intervention

EXPERIMENTAL

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

Stretching Intervention

EXPERIMENTAL

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

Interventions

Aerobic Training Intervention BEHAVIORAL

Aerobic Training Intervention

Stretching Intervention BEHAVIORAL

Stretching Intervention

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents ages 12 to 17 years
• Experienced a concussion 4 to 16 weeks prior to enrollment
• Experiencing persistent post-concussion symptoms

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (2)

• 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.

  PMID: 31620073 DERIVED

• 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.

  PMID: 27120294 DERIVED

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome; Athletic Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Brad Kurowski, MD, MS

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: January 14, 2014
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 11, 2016

Record last verified: 2016-02

Locations

US (1)