Safety Study for Adolescents With Concussion
Evaluation of the Safety of Exercise Testing With Acutely Concussed Adolescent Athletes
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 11, 2016
CompletedFirst Posted
Study publicly available on registry
March 21, 2016
CompletedMarch 21, 2016
March 1, 2016
2 years
March 11, 2016
March 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Full Recovery
Asymptomatic; Able to exercise to exhaustion without exacerbation of symptoms, confirmed by examination of a physician blinded to results
2-168 days
Study Arms (2)
BCTT
EXPERIMENTALParticipants 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.
No BCTT
NO INTERVENTIONAll 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adolescents with sports related concussion that appear for their first clinic visit within 10 days of injury
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University at Buffalo
Buffalo, New York, 14215, United States
Related Publications (1)
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.
PMID: 31377190DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John J Leddy, MD
University at Buffalo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 11, 2016
First Posted
March 21, 2016
Study Start
March 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
March 21, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share