Evaluation of the Safety of Exercise Testing With Acutely Concussed Adolescent Athletes
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University at Buffalo
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Time to Full Recovery
Overview
Brief Summary
The purpose of the study was to determine if administration of an exercise stress test within the first ten days after a sports related concussion would delay or otherwise interfere with recovery.
Detailed Description
The purpose of the study was to determine if administration of an exercise stress test within the first ten days after a sports related concussion would delay or otherwise interfere with recovery. All participants were adolescents injured while playing sports. All concussions were confirmed by an experienced sports medicine physician before random assignment of the participant to receive the treadmill test to determine exercise intolerance or not.
Recovery was defined as (a) return to asymptomatic state; (b) ability to exercise to exhaustion without exacerbation of symptoms and (c) confirmation of recovery by a physician who is blinded to the assignment and to results of exercise testing. Symptoms were self reported on a daily basis using an online data record.
Regardless of recovery rate all participants were assessed at two weeks following their first clinic visit. At the second visit all subjects, regardless of group assignment were assessed on ImPACT, and the treadmill based exercise stress test. Individuals who were not recovered by the second visit were followed until recovered no matter how long that took.
Analysis of data examined recovery rates of the two groups of adolescents to determine whether use of a exercise stress test early after concussion caused any adverse events or interfered in any way with recovery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adolescents with sports related concussion that appear for their first clinic visit within 10 days of injury
Exclusion Criteria
- •Evidence of focal neurologic deficit;
- •inability to exercise due to orthopaedic injury;
- •diabetes or known heart disease; increased cardiac risk; ADHD; depression; anxiety; history of moderate or severe brain injury; more than 3 prior concussions;
- •inability to understand spoken English.
Outcomes
Primary Outcomes
Time to Full Recovery
Time Frame: 2-168 days
Asymptomatic; Able to exercise to exhaustion without exacerbation of symptoms, confirmed by examination of a physician blinded to results
Secondary Outcomes
No secondary outcomes reported
Investigators
Barry Willer
Professor
University at Buffalo