- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03544346
Long-term Brain Health of Retired Professional Rugby Players, With a History of Concussion/Head Impact Exposure
An Investigation Into the Long-term Brain Health of Retired Professional Rugby Players, With a History of Concussion/Head Impact Exposure
There has been significant recent interest on the issue of brain health in athletes. Participation in sports is generally viewed as extremely positive. Consistent evidence supports associations among exercise, cognitive vitality, neural functioning and decreased risk of cognitive decline. However, In the last decade, a dramatic shift in both public and scientific perception around the long-term consequences of concussion is evident. Rugby is a popular full-contact sport played throughout the world at varying levels of competition, including professional level. The game exposes players to inherent risk of injury including repetitive head impacts, due to the high number of collisions and tackles involved. Perhaps not surprisingly, given the physical nature of the sport, rugby has one of the highest rates of concussion of all full-contact sports. Evidence from a recent meta-anaysis found the incidence of concussion to be 4.73 per 1000 player match hours. Given the high incidence of concussion that has been reported in the literature to date, the issue of concussion and repeated head impact exposure is of particular concern in rugby.
Comprehensive investigation of cognition in living retired sports persons with previous exposure to repetitive head impact is noticeably lacking in the literature to date. Findings are inconsistent and investigations are shrouded by consistent methodological biases and flaws, reducing the overall quality of the studies. Relatively little research has been conducted on the long-term effects of repetitive mild TBI or sports concussion on the retired athlete's brain health with ageing. The potential long-term consequences are poorly understood and warrant more research. This study aims to investigate the brain health of retired rugby players in comparison to retired rowers who have achieved the same levels of exercise, without exposure to SRCs
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary aim of this study is to investigate brain health and wellness of retired professional Irish rugby players in comparison to retired professional Irish rowers.
Objectives:
The objectives will be to:
Obtain detailed demographic and overall health information from the retired rugby players and retired rowers.
Use a battery of cognitive function tests to assess the cognitive health of the retired rugby players and retired rowers.
Obtain blood samples from the retired rugby players and retired rowers in order to test for biomarkers indicative of neurodegenerative disease.
Investigate rugby player's self-report history of sports-related concussion (number and nature of concussions) during their career. Player's self-report will be correlated where possible with established individual player medical data.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male A retired professional rugby player (no age limit), who has played at least one season of professional rugby. A retired international rower (no age limit), who completed and trained full time for at least one season.
Athletes who have given informed consent and are willing to participate in the study.
Exclusion Criteria:
- You have a history of a non-sports related moderate to severe concussion or brain injury (eg a motor vehicle accident) You have had a concussion in the last year. You have had treatment of chemotherapy or radiotherapy in last 12 months. You have a bleeding disorder (will exclude you from blood sampling only).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Retired professional rugby players
Rugby Players will Provide detailed demographic information Provide detailed overall health information Questionnaires Provide information on athlete's playing career; age of debut, career duration, number of seasons participated in. Provide information on concussion history. Be given a general health screen including- heart rate, blood pressure, body composition and height weight ratio. Perform a battery of neuropsychological tests (Sound-induced flash illusion and CANTAB, NART) Provide a sample of blood. |
Exploratory brain and general health assessment
|
Retired professional rowers
Rowers will Provide detailed demographic information Provide detailed overall health information Questionnaires Provide information on athlete's playing career; age of debut, career duration, number of seasons participated in. Provide information on concussion history. Be given a general health screen including- heart rate, blood pressure, body composition and height weight ratio. Perform a battery of neuropsychological tests (Sound-induced flash illusion and CANTAB, NART) Provide a sample of blood. |
Exploratory brain and general health assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain Health Assessment
Time Frame: 1 hour
|
Investigating cognitive functioning
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concussion History Assessment
Time Frame: 20 minutes
|
History of concussion/head impact exposure
|
20 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- JCunningham
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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