Skip to main content
Clinical Trials/NCT02959216
NCT02959216
Completed
Not Applicable

Sub-Symptom Aerobic Exercise Therapy to Improve Recovery From Acute Sport-Related Concussion: A Randomized Controlled Trial

Children's Hospital of Philadelphia3 sites in 1 country125 target enrollmentJuly 23, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Traumatic Brain Injury
Sponsor
Children's Hospital of Philadelphia
Enrollment
125
Locations
3
Primary Endpoint
Time to recovery
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 23, 2018
End Date
July 7, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Time to recovery

Time Frame: 3 to 28 days

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

Secondary Outcomes

  • Persistence of post-concussive symptoms(29 to 112 days)

Study Sites (3)

Loading locations...

Similar Trials