InjuriesNCT06264323
Incidence of Acute Injuries in Boxing
An observational study of Injuries, run by University of Iceland at 1 site in Iceland.
Trial summary
A prospective cohort study with 9 months follow up was carried out in 2017-2018. Boxers of both sexes 18 years and older from all 7 boxing clubs in Iceland were invited to participate in the study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injuries
- How many people
- 74 participants
- Where
- 1 siteIceland
- Study dates
- 1 Sep 2017to 30 Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Boxers training at one of seven boxing gyms in Iceland
Who may be able to join
- ≥18 years old
- currently training actively
- ≥ 6 months boxing experience OR currently training at an advanced level
Who cannot join
- < 18 years old
- not training actively
- < 6 months boxing experience OR not currently training at an advanced level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Acute Injuries in Boxing in Iceland With Focus on Head Injuries: A Prospective Cohort Study With Questionnaire
A prospective cohort study with 9 months follow up was carried out in 2017-2018. Boxers of both sexes 18 years and older from all 7 boxing clubs in Iceland were invited to participate in the study. Participants filled out a questionnaire on previous injuries during boxing training and competition and were evaluated on the Sport Concussion Assessment Tool 3rd edition (SCAT3). Exposure at training and competition was measured and any injuries sustained during the study period were recorded via text messages and phone calls every 2 weeks.
Read the detailed description
QUALITY ASSURANCE PLAN:
Master of Science (MSc) student monitored the data and guaranteed high data quality. Data was protected according to the Act on Data Protection and the Processing of Personal data (Icelandic law) and stored at the University of Iceland. Data was registered into Microsoft Excel and shared through a secure network with project advisors to promote transparency.
DATA CHECKS:
Data was checked for outliers.
SOURCE DATA VERIFICATION:
Data from printed out questionnaires, text messages and telephone calls was transferred manually to excel by the MSc student who double checked every information to makes sure there were no mistakes.
DATA DICTIONARY:
CTE: chronic traumatic encephalopathy; KO: knock out; TKO: technical knock out; TBI: traumatic brain injury; t-tau protein: total tau protein.
STANDARD OPERATION PROCEDURES:
Boxers were recruited through the MSc students visits to 7 boxing gyms in Iceland. Boxers got an oral introduction, followed by an invitation to participate in the study. After giving a written consent, subjective and objective outcome measures were collected by the MSc student and 2-3 trained research assistants.
Data was analysed by the MSc student using Microsoft Excel and SAS Analytics Software.
The MSc student was responsible for reporting adverse events and change management.
SAMPLE SIZE ASSESSMENT:
Sample size was set at 30 participants. To ensure that enough subjects finished the study after dropouts, for prediction analyses and the opportunity for subgroup analyses, at least 60 subjects were needed.
PLAN FOR MISSING DATA:
If data would have been found to be missing by any reason, each incident would be assessed by the MSc student and her advisors. Imputation methods might be used, the subject involved might have been asked to do a measurement or answer questionnaire again (depending on the time that has passed from the measurement/questionnaires until data is discovered missing) or the subject involved might be removed from the study.
STATISTICAL ANALYSIS PLAN:
Data analyses and statistics Database monitoring was performed by the MCs student and an advisor, independent of sponsors and competing interests.
Excel spreadsheets were used to calculate injury incidence per 100 participants, per 1,000 hours of training and per 100 fight participations, while injuries were calculated in number per participant after adjusting for dropouts. Injury incident rate was calculated for each location and each type of injuries. Analysis of variance (ANOVA) and t-tests were used to compare means. Chi-square test (χ2) was used to compare injury frequencies of different locations and different types of injuries between different training levels and to compare the difference in injury severity according to sex, training level, whether injury occurred during a training or a bout, age, years of training, injury location and injury type. Logistic regression was used to assess possible risk factors including BMI, age, sex, participants' dominant side, training level, years of boxing, whether participants were participating in other sports, number of hours spent training during the study period, number of hours spent training on average per week, participant competing in a bout during the study period, previous boxing related injuries, and loss in a bout during the study period.
- Conditions
- Injuries
- Keywords
- Injury incidence, Olympic boxing, Concussion, Acute, Musculoskeletal injuries
- Medical subject headings
- Wounds and Injuries, Brain Concussion
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
a short self-reported questionnaire on previous boxing-related injuries and demographics
Measured: 5 minutes
Sport Concussion Assessment Tool 3rd Edition (SCAT3)
A tool used to assess concussions in athletes 13 years and older. The test has eight subcomponents that are measured in the following order (note that for baseline measurement the first two components were not used):
- Glasgow Coma Scale (GCS): Assesses level of consciousness.
- Maddocks Score: Assesses orientation to time and place.
- Post-Concussion Symptom Scale (PCSS).
- Standard Assessment of Concussion (SAC).
- Neck Examination.
- Modified Balance Error Scoring System (mBESS).
- Coordination examination (finger-to-nose test).
- SAC delayed recall: Patient asked to recall the list of words given earlier.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Sep 2017
- Primary completion30 May 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuriesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Árni Árnason, PhD, Study chair, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264323
- Sponsor's protocol ID
- UI-5487
- Status last verified
- Jun 2022
- First submitted
- 29 Jun 2022
- Last updated
- 16 Feb 2024
- 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 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Acute Injuries in Boxing in Iceland With Focus on Head Injuries: A Prospective Cohort Study With Questionnaire
- ClinicalTrials.gov ID
- NCT06264323
- Acronym / sponsor ID
- UI-5487
- Conditions
- Injuries
- Keywords
- Injury incidence, Olympic boxing, Concussion, Acute, Musculoskeletal injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 16 Feb 2024 (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.
A prospective cohort study with 9 months follow up was carried out in 2017-2018. Boxers of both sexes 18 years and older from all 7 boxing clubs in Iceland were invited to participate in the study. Participants filled out a questionnaire on previous injuries during boxing training and competition and were evaluated on the Sport Concussion Assessment Tool 3rd edition (SCAT3). Exposure at training and competition was measured and any injuries sustained during the study period were recorded via text messages and phone calls every 2 weeks.
Detailed description
QUALITY ASSURANCE PLAN:
Master of Science (MSc) student monitored the data and guaranteed high data quality. Data was protected according to the Act on Data Protection and the Processing of Personal data (Icelandic law) and stored at the University of Iceland. Data was registered into Microsoft Excel and shared through a secure network with project advisors to promote transparency.
DATA CHECKS:
Data was checked for outliers.
SOURCE DATA VERIFICATION:
Data from printed out questionnaires, text messages and telephone calls was transferred manually to excel by the MSc student who double checked every information to makes sure there were no mistakes.
DATA DICTIONARY:
CTE: chronic traumatic encephalopathy; KO: knock out; TKO: technical knock out; TBI: traumatic brain injury; t-tau protein: total tau protein.
STANDARD OPERATION PROCEDURES:
Boxers were recruited through the MSc students visits to 7 boxing gyms in Iceland. Boxers got an oral introduction, followed by an invitation to participate in the study. After giving a written consent, subjective and objective outcome measures were collected by the MSc student and 2-3 trained research assistants.
Data was analysed by the MSc student using Microsoft Excel and SAS Analytics Software.
The MSc student was responsible for reporting adverse events and change management.
SAMPLE SIZE ASSESSMENT:
Sample size was set at 30 participants. To ensure that enough subjects finished the study after dropouts, for prediction analyses and the opportunity for subgroup analyses, at least 60 subjects were needed.
PLAN FOR MISSING DATA:
If data would have been found to be missing by any reason, each incident would be assessed by the MSc student and her advisors. Imputation methods might be used, the subject involved might have been asked to do a measurement or answer questionnaire again (depending on the time that has passed from the measurement/questionnaires until data is discovered missing) or the subject involved might be removed from the study.
STATISTICAL ANALYSIS PLAN:
Data analyses and statistics Database monitoring was performed by the MCs student and an advisor, independent of sponsors and competing interests.
Excel spreadsheets were used to calculate injury incidence per 100 participants, per 1,000 hours of training and per 100 fight participations, while injuries were calculated in number per participant after adjusting for dropouts. Injury incident rate was calculated for each location and each type of injuries. Analysis of variance (ANOVA) and t-tests were used to compare means. Chi-square test (χ2) was used to compare injury frequencies of different locations and different types of injuries between different training levels and to compare the difference in injury severity according to sex, training level, whether injury occurred during a training or a bout, age, years of training, injury location and injury type. Logistic regression was used to assess possible risk factors including BMI, age, sex, participants' dominant side, training level, years of boxing, whether participants were participating in other sports, number of hours spent training during the study period, number of hours spent training on average per week, participant competing in a bout during the study period, previous boxing related injuries, and loss in a bout during the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Boxers training at one of seven boxing gyms in Iceland
Key inclusion criteria (3 listed)
- ≥18 years old
- currently training actively
- ≥ 6 months boxing experience OR currently training at an advanced level
Key exclusion criteria (3 listed)
- < 18 years old
- not training actively
- < 6 months boxing experience OR not currently training at an advanced level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Questionnaire
Time frame: 5 minutes
a short self-reported questionnaire on previous boxing-related injuries and demographics
Sport Concussion Assessment Tool 3rd Edition (SCAT3)
Time frame: 15 minutes
A tool used to assess concussions in athletes 13 years and older. The test has eight subcomponents that are measured in the following order (note that for baseline measurement the first two components were not used): 1. Glasgow Coma Scale (GCS): Assesses level of consciousness. 2. Maddocks Score: Assesses orientation to time and place. 3. Post-Concussion Symptom Scale (PCSS). 4. Standard Assessment of Concussion (SAC). 5. Neck Examination. 6. Modified Balance Error Scoring System (mBESS). 7. Coordination examination (finger-to-nose test). 8. SAC delayed recall: Patient asked to recall the list of words given earlier.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Árni Árnason, PhD study chair
University of Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Injuries, run by University of Iceland at 1 site in Iceland.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Questionnaire (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 16 Feb 2024.