InjuriesNCT05488639
Injury and Illness Surveillance at FIFA U-17 & U-20 Women's World Cups.
An observational study of Injuries and Illness, run by Federation Internationale de Football Association at 1 site in Switzerland.
Trial summary
The primary objective is to provide an overview of the incidence and characteristics of time-loss injuries and illnesses during the FIFA U-20 and U-17 Women's World Cups in 2022. Read more about this study
- Who is it for?
- Ages 15 to 20 years, women only
- What is being tested?
- Registration of football exposure and occurrence of injuries and illnesses only
- How many people
- 672 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2022to 31 Dec 2024
- 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 15 to 20 years
- Women only
- Child, Adult
Study population: This research project will be performed at the FIFA U-20 Women's World Cup 2022 final tournament which is played in Alajuela and San José, Costa Rica between August 10 and August 28, 2022, and the FIFA U-17 Women's World Cup 2022 final tournament which is played in Bhubaneswar, Goa, and Navi Mumbai, India between October 11 and October 30th, 2022. Each tournament includes 16 national teams, and each team is allowed to select 21 players, giving at total of 336 potential participants per tournament. In total, 32 matches will be played over 19 days, with the 24 group stage matches played in the first 8 days and the 8 knock-out matches played in the last 9 days.
Who may be able to join
- All participating football players at the FIFA U-20 and U-17 Women's World Cup 2022.
Who cannot join
- No exclusion criteria are present except refusal to provide consent for data to me used in this study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Fèdèration Internationale de Football Association
Zurich, 8044
About this study
The primary objective is to provide an overview of the incidence and characteristics of time-loss injuries and illnesses during the FIFA U-20 and U-17 Women's World Cups in 2022.
Read the detailed description
This research project will be performed at the FIFA U-20 Women's World Cup 2022 final tournament which is played in Alajuela and San José, Costa Rica between August 10 and August 28, 2022, and the FIFA U-17 Women's World Cup 2022 final tournament which is played in Bhubaneswar, Goa, and Navi Mumbai, India between October 11 and October 30th, 2022.
Each tournament includes 16 national teams, and each team is allowed to select 21 players, giving at total of 336 potential participants per tournament. In total, 32 matches will be played over 19 days, with the 24 group stage matches played in the first 8 days and the 8 knock-out matches played in the last 9 days.
Study duration The study will start from the first day of training with the national team prior the tournament until the day of the last match of the tournament. Consequently, the number of recordings will vary between teams depending on the duration of their pre-tournament training (usually 1-3 weeks), and their performance and progression through the tournament. In order to assess the severity of injuries (based on the length of time a player is unable to play for), all injuries are to be recorded until they are fully rehabilitated, even if this is after the end of the tournament. Each contact person therefore also needs to report when an injured player who has left the tournament has returned to full training with their club team after the tournament.
Demographic information Individual demographic information, including age, height, weight, playing position, and leg dominance (preferred kicking leg), is collected following inclusion.
Injury \& illness registration Data on injury and illness is gathered following the recommended methodology in the football extension of the International Olympic Committee consensus statement on methods for recording and reporting of epidemiological data on injury and illness in sport.10 This includes characteristics such as mode of onset, injury mechanism, diagnosis and classification according to body area, tissue, and pathology type, and illness categories for organ system and etiology. Time-loss will be counted in number of days.
Exposure registration Training and match exposure will be recorded in minutes for each participant on a weekly basis for the duration of the tournament. Training exposure includes for example any sports-specific training, strength and conditioning sessions, and active recovery sessions. Illness exposure will be recorded in days for each participant from their first day of training until their last match.
The primary objective is to provide an overview of the incidence and characteristics of time-loss injuries and illnesses during the FIFA U-20 and U-17 Women's World Cups in 2022.
A secondary objective is to explore any differences in injury characteristics between the two age categories.
The primary variables of interest are time-loss injuries and time-loss illnesses.
- Time-loss is defined as inability of a player to complete the current or future training session or match.
- Injury is defined as tissue damage or other derangement of normal physical function resulting from rapid or repetitive transfer of kinetic energy.
- Illness is defined as a health-related complaint or disorder experienced by an athlete, not considered as an injury.
Descriptive statistics is used to provide an overview of the participant demographics and injury and illness occurrence. Injury incidence is calculated as number of injuries per 1000 hours of exposure, and injury burden is calculated as time-loss days per 1000 hours of exposure. Injury incidence and burden will be reported for training and match injuries separately. Illness incidence is calculated per 365 exposure days. Potential age group comparison in burden will be performed using an independent t-test/Mann-Whitney U Test depending on data distribution. Potential missing data will be excluded from analysis and reported accordingly.
Sample size No a priori sample size calculation is performed as we will attempt to include all eligible participants from the two tournaments giving a total possible sample size of 672 female football players.
- Being tested
- Registration of football exposure and occurrence of injuries and illnesses only
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registration of football exposure and occurrence of injuries and illnesses onlyOther
Injury \& illness registration
Data on injury and illness is gathered following the recommended methodology in the football extension of the International Olympic Committee consensus statement on methods for recording and reporting of epidemiological data on injury and illness in sport. This includes characteristics such as mode of onset, injury mechanism, diagnosis and classification according to body area, tissue, and pathology type, and illness categories for organ system and etiology. Time-loss will be counted in number of days.
| Study group | Role | What they receive |
|---|---|---|
| Football players at the FIFA U-20 Women's World Cup 2022. | * Upper age limit: all players must be a maximum of 20 years old by the end of the calendar year in which the World Cup 2022 is played (i.e. all players of the teams were born on or after 1 January 2002).
* Lower age limit: all players must be at least 16 years old by the end of the calendar year in which the World Cup 2022 is played (i.e. all players of the teams were born on or before 31 December 2006). Receives: Other: Registration of football exposure and occurrence of injuries and illnesses only | |
| Football players at the FIFA U-17 Women's World Cup 2022. | * Upper age limit: all players must be a maximum of 17 years old by the end of the calendar year in which the World Cup 2022 is played (i.e. all players of the teams were born on or after 1 January 2005).
* Lower age limit: all players must be at least 15 years old by the end of the calendar year in which the World Cup 2022 is played (i.e. all players of the teams were born on or before 31 December 2007). Receives: Other: Registration of football exposure and occurrence of injuries and illnesses only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-loss injury
- Time-loss is defined as inability of a player to complete the current or future training session or match.
- Injury is defined as tissue damage or other derangement of normal physical function resulting from rapid or repetitive transfer of kinetic energy.
Measured: August 2022
Time-loss illness
- Time-loss is defined as inability of a player to complete the current or future training session or match.
- Illness is defined as a health-related complaint or disorder experienced by an athlete, not considered as an injury.
Measured: October 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Oct 2022
- Study completion31 Dec 2024 (estimated)
Why it stopped: Insufficient participation
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
- 672 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federation Internationale de Football Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Serner, PhD, Principal investigator, Fédération Internationale de Football Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488639
- Sponsor's protocol ID
- 1
- Status last verified
- Mar 2024
- First submitted
- 3 Aug 2022
- Last updated
- 4 Mar 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injury and Illness Surveillance at FIFA U-17 & U-20 Women's World Cups.
- ClinicalTrials.gov ID
- NCT05488639
- Acronym / sponsor ID
- 1
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Insufficient participation
- Enrolment
- 672 participants (estimated)
- Lead sponsor
- Federation Internationale de Football AssociationUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Aug 2022 (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.
The primary objective is to provide an overview of the incidence and characteristics of time-loss injuries and illnesses during the FIFA U-20 and U-17 Women's World Cups in 2022.
Detailed description
This research project will be performed at the FIFA U-20 Women's World Cup 2022 final tournament which is played in Alajuela and San José, Costa Rica between August 10 and August 28, 2022, and the FIFA U-17 Women's World Cup 2022 final tournament which is played in Bhubaneswar, Goa, and Navi Mumbai, India between October 11 and October 30th, 2022.
Each tournament includes 16 national teams, and each team is allowed to select 21 players, giving at total of 336 potential participants per tournament. In total, 32 matches will be played over 19 days, with the 24 group stage matches played in the first 8 days and the 8 knock-out matches played in the last 9 days.
Study duration The study will start from the first day of training with the national team prior the tournament until the day of the last match of the tournament. Consequently, the number of recordings will vary between teams depending on the duration of their pre-tournament training (usually 1-3 weeks), and their performance and progression through the tournament. In order to assess the severity of injuries (based on the length of time a player is unable to play for), all injuries are to be recorded until they are fully rehabilitated, even if this is after the end of the tournament. Each contact person therefore also needs to report when an injured player who has left the tournament has returned to full training with their club team after the tournament.
Demographic information Individual demographic information, including age, height, weight, playing position, and leg dominance (preferred kicking leg), is collected following inclusion.
Injury \& illness registration Data on injury and illness is gathered following the recommended methodology in the football extension of the International Olympic Committee consensus statement on methods for recording and reporting of epidemiological data on injury and illness in sport.10 This includes characteristics such as mode of onset, injury mechanism, diagnosis and classification according to body area, tissue, and pathology type, and illness categories for organ system and etiology. Time-loss will be counted in number of days.
Exposure registration Training and match exposure will be recorded in minutes for each participant on a weekly basis for the duration of the tournament. Training exposure includes for example any sports-specific training, strength and conditioning sessions, and active recovery sessions. Illness exposure will be recorded in days for each participant from their first day of training until their last match.
The primary objective is to provide an overview of the incidence and characteristics of time-loss injuries and illnesses during the FIFA U-20 and U-17 Women's World Cups in 2022.
A secondary objective is to explore any differences in injury characteristics between the two age categories.
The primary variables of interest are time-loss injuries and time-loss illnesses.
- Time-loss is defined as inability of a player to complete the current or future training session or match.
- Injury is defined as tissue damage or other derangement of normal physical function resulting from rapid or repetitive transfer of kinetic energy.
- Illness is defined as a health-related complaint or disorder experienced by an athlete, not considered as an injury.
Descriptive statistics is used to provide an overview of the participant demographics and injury and illness occurrence. Injury incidence is calculated as number of injuries per 1000 hours of exposure, and injury burden is calculated as time-loss days per 1000 hours of exposure. Injury incidence and burden will be reported for training and match injuries separately. Illness incidence is calculated per 365 exposure days. Potential age group comparison in burden will be performed using an independent t-test/Mann-Whitney U Test depending on data distribution. Potential missing data will be excluded from analysis and reported accordingly.
Sample size No a priori sample size calculation is performed as we will attempt to include all eligible participants from the two tournaments giving a total possible sample size of 672 female football players.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Football players at the FIFA U-20 Women's World Cup 2022. | – | Other: Registration of football exposure and occurrence of injuries and illnesses only* Upper age limit: all players must be a maximum of 20 years old by the end of the calendar year in which the World Cup 2022 is played (i.e. all players of the teams were born on or after 1 January 2002). * Lower age limit: all players must be at least 16 years old by the end of the calendar year in which the World Cup 2022 is played (i.e. all players of the teams were born on or before 31 December 2006). |
| Football players at the FIFA U-17 Women's World Cup 2022. | – | Other: Registration of football exposure and occurrence of injuries and illnesses only* Upper age limit: all players must be a maximum of 17 years old by the end of the calendar year in which the World Cup 2022 is played (i.e. all players of the teams were born on or after 1 January 2005). * Lower age limit: all players must be at least 15 years old by the end of the calendar year in which the World Cup 2022 is played (i.e. all players of the teams were born on or before 31 December 2007). |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- This research project will be performed at the FIFA U-20 Women's World Cup 2022 final tournament which is played in Alajuela and San José, Costa Rica between August 10 and August 28, 2022, and the FIFA U-17 Women's World Cup 2022 final tournament which is played in Bhubaneswar, Goa, and Navi Mumbai, India between October 11 and October 30th, 2022. Each tournament includes 16 national teams, and each team is allowed to select 21 players, giving at total of 336 potential participants per tournament. In total, 32 matches will be played over 19 days, with the 24 group stage matches played in the first 8 days and the 8 knock-out matches played in the last 9 days.
Key inclusion criteria (1 listed)
- All participating football players at the FIFA U-20 and U-17 Women's World Cup 2022.
Key exclusion criteria (1 listed)
- No exclusion criteria are present except refusal to provide consent for data to me used in this study.
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 |
|---|---|---|
| Registration of football exposure and occurrence of injuries and illnesses onlyInjury \& illness registration Data on injury and illness is gathered following the recommended methodology in the football extension of the International Olympic Committee consensus statement on methods for recording and reporting of epidemiological data on injury and illness in sport. This includes characteristics such as mode of onset, injury mechanism, diagnosis and classification according to body area, tissue, and pathology type, and illness categories for organ system and etiology. Time-loss will be counted in number of days. | Other | Football players at the FIFA U-17 Women's World Cup 2022., Football players at the FIFA U-20 Women's World Cup 2022. |
Primary outcome
Time-loss injury
Time frame: August 2022
* Time-loss is defined as inability of a player to complete the current or future training session or match. * Injury is defined as tissue damage or other derangement of normal physical function resulting from rapid or repetitive transfer of kinetic energy.
Time-loss illness
Time frame: October 2022
* Time-loss is defined as inability of a player to complete the current or future training session or match. * Illness is defined as a health-related complaint or disorder experienced by an athlete, not considered as an injury.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 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.
Andreas Serner, PhD principal investigator
Fédération Internationale de Football Association
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 and Illness, run by Federation Internationale de Football Association at 1 site in Switzerland.
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 1 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: paused, as of the sponsor's last update on 4 Mar 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 Switzerland. 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?
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?
Time-loss injury (time frame: August 2022). 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 4 Mar 2024.