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Aerobic Exercise + Screen Time Management for Concussion Recovery
N/A
Recruiting
Research Sponsored by Children's Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subjects aged 12-17 years 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 sport-related concussion
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up greater than 30-days
Awards & highlights
Study Summary
This trial will compare the effect of different activities on concussion recovery time for adolescents.
Who is the study for?
Adolescents aged 12-17 who've had a sport-related concussion within the last 72 hours can join this trial. They must be able to visit Andrews clinic in Plano, Texas, and not have other conditions that could affect recovery like ADHD or more than three prior concussions.Check my eligibility
What is being tested?
The study is testing how screen time restriction, aerobic exercise alone, both combined, or just stretching (control group) affects concussion recovery time in teens. Participants are randomly assigned to one of these groups for comparison.See study design
What are the potential side effects?
Since the interventions involve common activities like exercising and limiting screen time rather than medication, significant side effects are not expected. However, any physical activity may cause discomfort or fatigue especially if done soon after a concussion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12-17 years old, treated for a sports-related concussion at Andrews in Plano, Texas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ greater than 30-days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~greater than 30-days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recovery Time
Secondary outcome measures
Protracted recovery
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Screen Time Restricted & Aerobic ExerciseExperimental Treatment1 Intervention
Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) as well as engage in 30-minutes of AE in the form of a stationary exercise bike, treadmill, or outdoors, for the first 72-hours following the initial clinic visit. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.
Group II: Screen Time RestrictedExperimental Treatment1 Intervention
Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) for the first 72-hours following the initial clinic visit. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.
Group III: Aerobic ExerciseExperimental Treatment1 Intervention
Participants will be asked to engage in 30-minutes of aerobic exercise (AE) daily for the first 72-hours following the initial clinic visit in the form of a stationary exercise bike, treadmill, or outdoors. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.
Group IV: StretchingActive Control1 Intervention
Participants will be asked to follow a daily stretching program for the first 72-hours following the initial clinic visit. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise (AE)
2003
N/A
~200
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonOTHER
904 Previous Clinical Trials
320,647 Total Patients Enrolled
Children's HealthLead Sponsor
7 Previous Clinical Trials
406 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 12-17 years old, treated for a sports-related concussion at Andrews in Plano, Texas.I have not been diagnosed with a concussion from sports.I have an injury that could affect my physical activity during recovery.My concussion symptoms are mild, scoring under 5.I am being treated for ADHD, learning disorders, depression, anxiety, or have had more than 3 concussions.
Research Study Groups:
This trial has the following groups:- Group 1: Stretching
- Group 2: Screen Time Restricted
- Group 3: Screen Time Restricted & Aerobic Exercise
- Group 4: Aerobic Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment rate of this medical research project?
"Correct. The clinical trial is still searching for participants and the details of this study were most recently updated on August 22nd 2022, as indicated by information listed on clinicaltrials.gov. To date, 313 patients are needed from 1 site."
Answered by AI
Which individuals meet the criteria to be included in this research endeavor?
"This trial seeks to include 313 adolescent males and females, aged 12-17 years old, who sustained a sports-related concussion (SRC) within the prior 72 hours. Candidates must present for treatment at the Children's Health Andrews Institute for Orthopaedics and Sports Medicine in Plano, Texas."
Answered by AI
Are there any available openings for volunteers to participate in this trial?
"According to the most recent information posted by clinicaltrials.gov, this study is actively recruiting participants with July 1st 2022 being its launch date and August 22nd 2022 as its latest update."
Answered by AI
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