UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052250 |
|---|---|
| Receipt number | R000059642 |
| Scientific Title | Characteristics and Incidence of Running-Related Injuries in Male Collegiate Long-Distance Runners |
| Date of disclosure of the study information | 2023/09/25 |
| Last modified on | 2025/03/22 21:31:16 |
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Basic information
Public title
Characteristics and Incidence of Running-Related Injuries in Male Collegiate Long-Distance Runners
Acronym
Running Disorders in Long Distance Runners
Scientific Title
Characteristics and Incidence of Running-Related Injuries in Male Collegiate Long-Distance Runners
Scientific Title:Acronym
Running Disability Characteristics and Incidence in Male Collegiate Long Distance Runners
Region
| Japan |
Condition
Condition
Running-related injuries
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the characteristics of running-related disorders, the incidence of disorders, and factors related to these disorders among male collegiate long-distance runners, based on the body part where the disorder occurred, the distance and time of running, and the environment during running.
Basic objectives2
Others
Basic objectives -Others
Factors related to running-related disability should be identified based on the body part where the disability occurred, the distance and time of the run, and the environment during the run.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Injuries occurring during practice or competition were to be reported using a Google form on the day they occurred. The information included the date of the injury, the number of body parts injured, the area of injury and its details, the name of the diagnosis, and the symptoms of the injury.
Key secondary outcomes
You will be asked to report the details of your practice (race) for the day using a Google form. The content included: content of practice, any injuries on that day, total distance run, average time, environment, hills, warm-up, cool-down, sleep time, and return from injury (if injury kept them away from running).
The baseline questionnaire also included name, university name and grade, age, email address, height, weight, athletic history, personal bests (10,000 m track, 10 km marathon, and 5,000 m in high school), distance run in a day during high school, running time, living space, and whether living space was covered, The following information shall be used: history in the past year, the intensity of pain (NRS) when taking time off from practice in case of injury or breakdown.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Athletes must be enrolled in the ekiden club or track and field club (long-distance block) of a university with a training base in Saitama Prefecture and be in their first to third year of university as of December 1, 2023.
Key exclusion criteria
Those who could not give their consent to participate in this study and those who could not respond to the training logbook and injuries were excluded.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Saitama Medical University
Division name
Faculty of Health & Medical Care
Zip code
350-0496
Address
981 Kawakado, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL
049-295-1001
kawakado@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Akiyama |
Organization
Saitama Medical University
Division name
Graduate School of Medicine
Zip code
350-0496
Address
981 Kawakado, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL
049-295-1001
Homepage URL
kawakado@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
Ethical Committee of Saitama Medical University
Address
38, Moro Hongo, Moroyama-cho, Iruma-gun, Saitama, Japan
Tel
049-276-2143
rinri@saitama-med.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
| 2023 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2023 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
During the survey period, we will ask participants to report on your daily practice (race) activities, including days off, using Google form. If an injury occurs during training or racing, we will ask them to report the area where the injury occurred, its details, and the name of the diagnosis using Google Form.
Management information
Registered date
| 2023 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059642
