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Behavioral Intervention
Exercise for Concussion
N/A
Recruiting
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic at time of exercise prescription
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours after concussion diagnosis and then every other day until participant reports symptom free which takes, on median, 6 days with a range of 0-203 days at the research site.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see how different levels of exercise intensity affect concussion symptoms in college athletes. Participants will be split into two groups and will start exercising 48 hours after their diagnosis. The study will look
Who is the study for?
This trial is for varsity collegiate athletes who have been diagnosed with a concussion and are still experiencing symptoms at the time they start the exercise program. Athletes will be excluded if they do not meet these criteria.
What is being tested?
The study is testing how prescribed treadmill walking at two different intensities (light vs. moderate) affects pain-related fear, anxiety, depression, symptoms, and recovery time after a concussion.
What are the potential side effects?
Since this trial involves light to moderate treadmill walking as an intervention, side effects may include typical exercise-related responses such as muscle soreness or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I feel symptoms when I start exercising.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours after concussion diagnosis and then every other day until participant reports symptom free which takes, on median, 6 days with a range of 0-203 days at the research site.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours after concussion diagnosis and then every other day until participant reports symptom free which takes, on median, 6 days with a range of 0-203 days at the research site.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Athlete Fear Avoidance Questionnaire (AFAQ)
Days until symptom-free
Revised Head Injury Scale (HIS-r)
+1 moreSecondary study objectives
Days until return to sport
Generalized Anxiety Index-7 (GAD-7)
Patient Health Questionnaire-9 (PHQ-9)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Moderate IntensityExperimental Treatment1 Intervention
Treadmill walking at a rating of perceived exertion (RPE) of 13.
Group II: Light IntensityExperimental Treatment1 Intervention
Treadmill walking at a rating of perceived exertion (RPE) of 9.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treadmill Walking
2013
N/A
~100
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
785 Previous Clinical Trials
1,316,400 Total Patients Enrolled