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Safety Study for Adolescents With Concussion

Primary Purpose

Brain Injury, Concussion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise stress test (BCTT)
Sponsored by
University at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Injury

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University at Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BCTT

No BCTT

Arm Description

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.

All participants in the no intervention arm did not get assessed using the BCTT until they had fully recovered or when they had their second clinic visit fourteen days after their first visit.

Outcomes

Primary Outcome Measures

Time to Full Recovery
Asymptomatic; Able to exercise to exhaustion without exacerbation of symptoms, confirmed by examination of a physician blinded to results

Secondary Outcome Measures

Full Information

First Posted
March 11, 2016
Last Updated
March 18, 2016
Sponsor
University at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT02714192
Brief Title
Safety Study for Adolescents With Concussion
Official Title
Evaluation of the Safety of Exercise Testing With Acutely Concussed Adolescent Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Concussion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCTT
Arm Type
Experimental
Arm Description
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.
Arm Title
No BCTT
Arm Type
No Intervention
Arm Description
All participants in the no intervention arm did not get assessed using the BCTT until they had fully recovered or when they had their second clinic visit fourteen days after their first visit.
Intervention Type
Other
Intervention Name(s)
Exercise stress test (BCTT)
Intervention Description
Participants are assessed for exercise tolerance using a treadmill with gradually increasing angle to increase workload. Stress test is stopped when there is symptom exacerbation or when participant experiences voluntary exhaustion.
Primary Outcome Measure Information:
Title
Time to Full Recovery
Description
Asymptomatic; Able to exercise to exhaustion without exacerbation of symptoms, confirmed by examination of a physician blinded to results
Time Frame
2-168 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Leddy, MD
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31377190
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.
Results Reference
derived

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Safety Study for Adolescents With Concussion

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