Aerobic Exercise (AE) for Sport-related Concussion

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's Health - Andrews Institute, Plano, TX
Sport-related Concussion
Aerobic Exercise (AE) - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effect of different activities on concussion recovery time for adolescents. This trial will test whether or not AE is an effective treatment for Sport-related Concussion. The trial will last for 12 weeks, and all participants will be monitored for side effects.This trial will test the efficacy of Aerobic Exercise (AE) in treating Sport-related Concussion. All patients enrolled will participate in AE for 12 weeks, with no placebo group. This study is significant because AE has previously been approved by the FDA for a different condition, but its efficacy in treating Sport-related Concussion has not been proven.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Sport-related Concussion

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Greater than 30-days

Day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities
Recovery Time
Greater than 30-days
Protracted recovery

Trial Safety

Safety Progress

1 of 3

Other trials for Sport-related Concussion

Trial Design

4 Treatment Groups

Stretching
1 of 4
Screen Time Restricted & Aerobic Exercise
1 of 4
Screen Time Restricted
1 of 4
Aerobic Exercise
1 of 4
Active Control
Experimental Treatment

313 Total Participants · 4 Treatment Groups

Primary Treatment: Aerobic Exercise (AE) · No Placebo Group · N/A

Screen Time Restricted & Aerobic Exercise
Behavioral
Experimental Group · 1 Intervention: Screen-time restricted plus aerobic exercise (STR+AE) · Intervention Types: Behavioral
Screen Time Restricted
Behavioral
Experimental Group · 1 Intervention: Screen Time Restriction (ST-Restricted) · Intervention Types: Behavioral
Aerobic Exercise
Behavioral
Experimental Group · 1 Intervention: Aerobic Exercise (AE) · Intervention Types: Behavioral
Stretching
Behavioral
ActiveComparator Group · 1 Intervention: Stretching Only · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise (AE)
2003
N/A
~200

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: greater than 30-days
Closest Location: Children's Health - Andrews Institute · Plano, TX
Photo of texas 1Photo of texas 2Photo of texas 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Sport-related Concussion
0 CompletedClinical Trials

Who is running the clinical trial?

Children's HealthLead Sponsor
4 Previous Clinical Trials
374 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
786 Previous Clinical Trials
245,380 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a male or female.
You are aged 12-17 years of age presenting to the Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) concussion clinic in Plano, Texas, to be treated for a diagnosed SRC.
You have suffered a concussion within 72-hours of your first clinic visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.