UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059558 |
|---|---|
| Receipt number | R000068046 |
| Scientific Title | Epidemiological survey of sports injuries and disorders in professional American football players |
| Date of disclosure of the study information | 2025/10/27 |
| Last modified on | 2025/10/27 20:31:43 |
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Basic information
Public title
Epidemiological survey of sports injuries and disorders in professional American football players
Acronym
Epidemiological survey of sports injuries and disorders in professional American football players
Scientific Title
Epidemiological survey of sports injuries and disorders in professional American football players
Scientific Title:Acronym
Epidemiological survey of sports injuries and disorders in professional American football players
Region
| Japan |
Condition
Condition
Sports injuries
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the incidence, severity, and causes of sports injuries and disorders among professional American football players through a compilation of data and an epidemiological survey, and at the same time to investigate the epidemiological characteristics of diseases for which acupuncture treatment is indicated.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to clarify the incidence, severity, and causes of sports injuries and disorders among professional American football players through a compilation of data and an epidemiological survey, and at the same time to investigate the epidemiological characteristics of diseases for which acupuncture treatment is indicated.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Number of Sports Injuries
2) Number of Sports Injuries
3) Athlete Exposure
4) Athlete Hours
5) Prevalence (%)
6) Incidence (Incidence: Cases/1,000 Athlete Exposures, Cases/1,000 Athlete Hours)
7) Injury Risk Ratio
8) Injury Rate Ratio (Injury Rate: 1,000/Athlete Exposures, 1,000/Athlete Hours)
9) Injury Burden (Injury Burden: Incidence (Athlete Exposure, Athlete Hours) x Severity)
Key secondary outcomes
Pain VAS, exercise status VAS
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
American football players who have suffered sports injuries
Athletes who have been absent from scheduled practice for more than 24 hours due to a sports injury or disability
Key exclusion criteria
Athletes who were able to participate in scheduled practice within 24 hours due to a sports injury or disability
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Fujimoto |
| Middle name | |
| Last name | Hideki |
Organization
Tokyo Ariake University of Medical and Medical Health Sciences
Division name
Faculty of Health Sciences, Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1 Ariake, Koto-ku, Tokyo, Japan
TEL
03-6703-7000
fujimoto@tau.ac.jp
Public contact
Name of contact person
| 1st name | Fujimoto |
| Middle name | |
| Last name | Hideki |
Organization
Tokyo Ariake University of Medical and Medical Health Sciences
Division name
Faculty of Health Sciences, Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1 Ariake, Koto-ku, Tokyo, Japan
TEL
03-6703-7000
Homepage URL
fujimoto@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Medical Health Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Ariake University of Medical and Medical Health Sciences
Address
2-9-1 Ariake, Koto-ku, Tokyo, Japan
Tel
03-6703-7000
soumu@tau.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
61
Results
Injury incidence and burden among adult amateur American football players were 6.45 cases and 121.07 days per 1,000 athlete-hours, respectively; rates were highest during games, particularly for thigh muscle strains, and occurred more often in defensive players and during the preparation months of March and August.
Results date posted
| 2025 | Year | 10 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were 61 players: age 28.2(5.6) years, height 178.3 (6.7) cm, weight 88.3(17.6) kg from Adult American Football Team A between February and November 2014. Players registered for the official games in the autumn season were included, while those not registered or who left the team during the season were excluded.
Participant flow
Records of injuries and injuries were collected from players who belonged to the team between February and November 2014. This study was based on these records. Records of injuries and injuries that occurred during American football practice and games during the study period were recorded at each activity. Records of the sports injuries and injuries were conducted in accordance with previous studies after diagnosis and evaluation by the team doctor and trainer. The number of injured players and the number of sports injuries and injuries by location and type (name of injury) were tallied, and severity (days), athlete-hours (hereinafter referred to as AH), incidence (incidents/1,000 AH), and injury burden (days and incidents/1,000 AH) were calculated.
Adverse events
None
Outcome measures
The AH required to calculate the incidence was calculated by multiplying the number of team activities and activity time by the number of players who participated. The number of sports injuries and disorders was divided by AH and multiplied by 1,000 to calculate the incidence per 1,000 hours of activity time (cases/1,000AH). Additionally, the mean and 95% confidence interval (95% CI) of the duration of absence from competition for each location and type (name of injury) of sports injuries and disorders was calculated to determine the severity (days) of the sports injuries and disorders. The product of the incidence (cases/1,000AH) and severity was calculated as the injury burden (days/cases/1,000AH).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nine
Management information
Registered date
| 2025 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068046
