Aerobic Exercise for Concussion

Not Applicable

Completed

• Conditions: Brain Concussion; Mild Traumatic Brain Injury; Acute Brain Injury

• 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.

Study Timeline

• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-09
• Study Start: 2018-07-23
• Primary Completion: 2020-04-01
• Study Completion: 2020-07-07
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24

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

Primary Outcome Measures

Name	Time	Method
Time to recovery	3 to 28 days	Recovery is defined as symptom resolution, exercise tolerance, and normal clinical examination.

Secondary Outcome Measures

Name	Time	Method
Persistence of post-concussive symptoms	29 to 112 days

Trial Locations

Locations (3)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

University at Buffalo; 🇺🇸 Buffalo, New York, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States