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Aerobic Exercise for Concussion

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ClinicalTrials.gov Identifier: NCT02959216
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : November 24, 2020
Sponsor:
Collaborators:
University at Buffalo
Boston Children's Hospital
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
The use of aerobic exercise treatment in the chronic phase of concussion recovery is well-described in the literature but there are limited existing data on the effect of exercise treatment in the acute phase after sport-related concussion (SRC). This study will compare the outcomes of adolescents with a recent SRC who are randomized to sub-threshold aerobic exercise versus those randomized to placebo stretching to evaluate the effect of aerobic exercise in the acute recovery phase.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Acute Brain Injury Brain Concussion Other: Aerobic Exercise Other: Stretching Exercise Not Applicable

Detailed Description:
Historically, concussion has been described as a cognitive injury and patients have been advised not to engage in any cognitive or physical exertion while symptomatic. More recently, however, concussion has been described as a physiological injury affecting both the heart and autonomic nervous system, and patients suffering from prolonged concussion-related symptoms and deficits have been encouraged to begin aerobic exercise as part of their concussion care. While intensive exercise too soon after concussion has been associated with delayed recovery and used to justify prolonged periods of rest, recent studies have shown that controlled, sub-symptom threshold aerobic exercise may aid recovery by improving autonomic balance and cerebral blood flow auto-regulation after concussion. This study will randomly assign pediatric patients with concussion to a treatment group in which they will complete sub-symptom threshold aerobic exercise or to a placebo group in which they will complete a standardized stretching protocol. All participants will have routine visits that consist of a physical examination and exercise test until the intervention ends at recovery or 1-month post-randomization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Sub-Symptom Aerobic Exercise Therapy to Improve Recovery From Acute Sport-Related Concussion: A Randomized Controlled Trial
Actual Study Start Date : July 23, 2018
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : July 7, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Exercise
Aerobic exercise participants will receive an exercise prescription based on their heart rate threshold (HRT) for symptom exacerbation during an initial treadmill test. Participants will be asked to exercise once a day up to 90% of their assigned HRT for a minimum of 20 minutes. Participants will wear a heart rate monitor to track their heart rate during aerobic exercise. The treatment will continue until the participant is recovered from his/her concussion, as determined by exercise tolerance and a normal symptom count and clinical examination.
Other: Aerobic Exercise
Participants will be given a prescription to exercise up to 90% of their threshold heart rate for symptom exacerbation. Heart rate threshold will be monitored weekly in order to increase exercise level accordingly.

Placebo Comparator: Stretching Exercise
Stretching exercise participants will receive a prescription to complete a standardized physical therapy stretching protocol once a day for approximately 20 minutes. Participants will wear a heart rate monitor to track their heart rate during the stretching exercise. The treatment will continue until the participant is recovered from his/her concussion, as determined by exercise tolerance and a normal symptom count and clinical examination.
Other: Stretching Exercise
Participants will be given a prescription to complete a standardized stretching protocol.




Primary Outcome Measures :
  1. Time to recovery [ Time Frame: 3 to 28 days ]
    Recovery is defined as symptom resolution, exercise tolerance, and normal clinical examination.


Secondary Outcome Measures :
  1. Persistence of post-concussive symptoms [ Time Frame: 29 to 112 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (Case Subjects):

  • Sports-related concussion (organized or recreational).
  • Physician-diagnosed concussion within the last 10 days.
  • Symptom score difference ≥3 on the Post-Concussion Symptom Inventory (PCSI) Current versus PCSI Pre-Injury.
  • Parental/guardian permission (informed consent) and child assent.

Inclusion Criteria (Control Subjects):

  • No known recent concussion within the past year or still causing active symptoms.
  • Parental/guardian permission (informed consent) and child assent.

Exclusion Criteria (Case and Control Subjects):

  • Subjects with moderate or severe traumatic brain injury as indicated by a score <13 on Glasgow Coma Scale (GCS), presence of lesion on CT/MRI, and/or focal neurologic deficit consistent with an intracerebral lesion.
  • History of more than 3 diagnosed concussions.
  • Subjects that sustained an injury involving loss of consciousness for 30+ minutes or post-traumatic amnesia for 24+ hours.
  • Inability to exercise because of lower-extremity orthopedic injury, significant vestibular or visual dysfunction, or increased cardiac risk.
  • Pre-existing comorbidities, such as chronic pain, cardiac, neurological, or autoimmune conditions, that prevent participation in active testing and/or rehabilitation.
  • Currently taking medications that can affect autonomic function.
  • Active substance abuse/dependence.
  • Unwillingness to exercise or unable to access place to safely exercise.
  • Parental/guardian permission (informed consent) not obtainable or not provided
  • Cannot understand English.

Exclusion Criteria (Case Subjects Only):

  • Additional head injury during the intervention.
  • Parents/ guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959216


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02155
United States, New York
University at Buffalo
Buffalo, New York, United States, 14214
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
University at Buffalo
Boston Children's Hospital
Investigators
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Principal Investigator: John Leddy, MD University at Buffalo
Principal Investigator: Christina Master, MD Children's Hospital of Philadelphia
Principal Investigator: Rebekah Mannix, MD Boston Children's Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02959216    
Other Study ID Numbers: 15-012491
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
Aerobic Exercise
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating