Brain Health Retired Elite AthletesNCT03544346
Long-term Brain Health of Retired Professional Rugby Players, With a History of Concussion/Head Impact Exposure
An observational study of Brain Health Retired Elite Athletes, run by University of Dublin, Trinity College.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Brain Health Retired Elite Athletes
- What is being tested?
- Exploratory brain and general health assessment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 18 Jun 2018to 15 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Professional sport athletes with a career in elite rowing or rugby
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: 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
Read the 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.
- Conditions
- Brain Health Retired Elite Athletes
- Being tested
- Exploratory brain and general health assessment
- Keywords
- brain health, professional athlete, retired, neuropsychological assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exploratory brain and general health assessmentOther
Exploratory brain and general health assessment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: Exploratory brain and general health assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Health Assessment
Investigating cognitive functioning
Measured: 1 hour
Secondary outcomes (1)
Concussion History Assessment
History of concussion/head impact exposure
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start18 Jun 2018 (estimated)
- Primary completion15 Dec 2018 (estimated)
- Study completion15 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Health Retired Elite AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joice Cunningham, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544346
- Sponsor's protocol ID
- JCunningham
- Status last verified
- May 2018
- First submitted
- 21 May 2018
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Long-term Brain Health of Retired Professional Rugby Players, With a History of Concussion/Head Impact Exposure
- ClinicalTrials.gov ID
- NCT03544346
- Acronym / sponsor ID
- JCunningham
- Conditions
- Brain Health Retired Elite Athletes
- Keywords
- brain health, professional athlete, retired, neuropsychological assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- 18 Jun 2018 (estimated)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 15 Dec 2018 (estimated)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retired professional rugby players | – | Other: Exploratory brain and general health assessmentRugby 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. |
| Retired professional rowers | – | Other: Exploratory brain and general health assessmentRowers 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Professional sport athletes with a career in elite rowing or rugby
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exploratory brain and general health assessmentExploratory brain and general health assessment | Other | Retired professional rowers, Retired professional rugby players |
Primary outcome
Brain Health Assessment
Time frame: 1 hour
Investigating cognitive functioning
1 secondary outcome
Concussion History Assessment
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Health Retired Elite Athletes, run by University of Dublin, Trinity College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Health Assessment (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.