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Aerobic Exercise for Concussion

Not Applicable
Completed
Conditions
Brain Concussion
Mild Traumatic Brain Injury
Acute Brain Injury
Interventions
Other: Aerobic Exercise
Other: Stretching Exercise
Registration Number
NCT02959216
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
125
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Aerobic ExerciseAerobic ExerciseAerobic 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.
Stretching ExerciseStretching ExerciseStretching 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.
Primary Outcome Measures
NameTimeMethod
Time to recovery3 to 28 days

Recovery is defined as symptom resolution, exercise tolerance, and normal clinical examination.

Secondary Outcome Measures
NameTimeMethod
Persistence of post-concussive symptoms29 to 112 days

Trial Locations

Locations (3)

Children's Hospital of Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

Boston Children's Hospital

🇺🇸

Boston, Massachusetts, United States

University at Buffalo

🇺🇸

Buffalo, New York, United States

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