Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264323
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2022-06-29
Brief Title:
Incidence of Acute Injuries in Boxing
Sponsor:
University of Iceland
Organization:
University of Iceland
Study Overview
Official Title:
Incidence of Acute Injuries in Boxing in Iceland With Focus on Head Injuries A Prospective Cohort Study With Questionnaire
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 measurementquestionnaires 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 1000 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
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 measurementquestionnaires 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 1000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None