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Clinical Trials/NCT02714192
NCT02714192
Completed
Not Applicable

Evaluation of the Safety of Exercise Testing With Acutely Concussed Adolescent Athletes

University at Buffalo1 site in 1 country54 target enrollmentStarted: March 2013Last updated:

Overview

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Barry Willer

Professor

University at Buffalo

Study Sites (1)

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