Clinical trial NCT02714192: Safety Study for Adolescents With Concussion
Official title: Evaluation of the Safety of Exercise Testing With Acutely Concussed Adolescent Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Concussion
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 54
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Full Recovery
timeFrame: 2-168 days
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: John J Leddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Willer BS, Haider MN, Bezherano I, Wilber CG, Mannix R, Kozlowski K, Leddy JJ. Comparison of Rest to Aerobic Exercise and Placebo-like Treatment of Acute Sport-Related Concussion in Male and Female Adolescents. Arch Phys Med Rehabil. 2019 Dec;100(12):2267-2275. doi: 10.1016/j.apmr.2019.07.003. Epub 2019 Aug 1.