Safety Study for Adolescents With Concussion

Not Applicable

Completed

• Conditions: Brain Injury; Concussion
• Interventions: Other: Exercise stress test (BCTT)

• Registration Number: NCT02714192
• Lead Sponsor: University at Buffalo

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 Timeline

• Study Start: 2013-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-03
• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-18
• Last Update Submitted: 2016-03-18
• Study First Posted: 2016-03-21
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCTT	Exercise stress test (BCTT)	Participants received an standardized exercise stress test within 7 days of concussive injury. Stress test is stopped when participant experiences any exacerbation of symptoms. Heart rate at time of symptom exacerbation is referred to as the threshold heart rate (THR). Stress test is known as the Buffalo Concussion Treadmill Test.

Primary Outcome Measures

Name	Time	Method
Time to Full Recovery	2-168 days	Asymptomatic; Able to exercise to exhaustion without exacerbation of symptoms, confirmed by examination of a physician blinded to results

Trial Locations

Locations (1)

University at Buffalo; 🇺🇸 Buffalo, New York, United States