Acute Brain Injury, Brain Concussion, Mild Traumatic Brain Injury
Conditions
Keywords
Aerobic Exercise
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.
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.
Interventions
OTHERAerobic 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.
OTHERStretching Exercise
Participants will be given a prescription to complete a standardized stretching protocol.
Sponsors
University at Buffalo
Boston Children's Hospital
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recovery | 3 to 28 days | Recovery is defined as symptom resolution, exercise tolerance, and normal clinical examination. |
Secondary
| Measure | Time frame |
|---|---|
| Persistence of post-concussive symptoms | 29 to 112 days |
Countries
United States
Outcome results
None listed