UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036863 |
|---|---|
| Receipt number | R000041938 |
| Scientific Title | Physical characteristics of high school soccer players with groin pain and effect of prevention program. |
| Date of disclosure of the study information | 2019/05/30 |
| Last modified on | 2021/10/14 19:00:39 |
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Basic information
Public title
Physical characteristics of high school soccer players with groin pain and effect of prevention program.
Acronym
Physical characteristics of high school soccer players with groin pain and effect of prevention program.
Scientific Title
Physical characteristics of high school soccer players with groin pain and effect of prevention program.
Scientific Title:Acronym
Physical characteristics of high school soccer players with groin pain and effect of prevention program.
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the preventive effect of high school football players by performing Copenhagen Adduction Exercise and Nordic Hamstrings Exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Injury rate of adductor muscle and hamstrings
16 weeks training time
16 weeks match time
16 weeks of injury
16 weeks off training due to injury
16 weeks off due to damage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Copenhagen adduction exercise for 5 minute a day will be performed for 2 times a week in 16 weeks.
Interventions/Control_2
Copenhagen adduction exercise and Nordic hamstrings execise for 8 minute a day will be performed for 2-3 times a week in 16 weeks.
Interventions/Control_3
A control group performs the usual practice.
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male
Key inclusion criteria
1,Male high school soccer player.
2,The player who does not have any treatment during this study.
Key exclusion criteria
1,The player who couldn't get consent of participation in this study.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Medical Science, Graduate School of Medicine, Saitama Medical University
Division name
Department of Physical Therapy
Zip code
350-0496
Address
981 Kawakado Moroyamamachi Irumagun, Saitama
TEL
049-295-8246
akasaka-msc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Fujisaki |
Organization
Medical Science, Graduate School of Medicine, Saitama Medical University
Division name
Department of Physical Therapy
Zip code
350-0496
Address
981 Kawakado Moroyamamachi Irumagun, Saitama
TEL
049-295-8246
Homepage URL
kazuki.0838@gmail.com
Sponsor or person
Institute
Department of Physical Therapy, Medic
al Science, Graduate School of Medicine, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Physical Therapy, Medic
al Science, Graduate School of Medicine, 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
Medical Science, Graduate School of Medicine, Saitama Medical University
Address
981 Kawakado Moroyamamachi Irumagun, Saitama
Tel
049-295-8246
kazuki.0838@gmail.com
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
| 2019 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Not open to the public
Publication of results
Unpublished
Result
URL related to results and publications
Not open to the public
Number of participants that the trial has enrolled
202
Results
Injury survey calculated the injury rate and relative risk per 1,000 hours, and medical check extracted related factors.
The effect of groin pain prevention exercise was considered to be that the intervention group reduced the injury rate, and in particular, the synergistic effect of CAE and NHE could enhance the injury prevention of groin pain.
Results date posted
| 2021 | Year | 06 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were male high school students participating in a Japanese under 18 soccer leagues. The league level was set for the prefecture's top league and high schools belonging to all school leagues, and the players belonging to the top team were targeted.
Participant flow
We considered it would be difficult to blind subjects through individual subject randomization, so each high school formed a cluster group which were then randomized using the envelope method. After a team agreed to participate, the principal investigator opened a sealed envelope revealing their group assignment. Group A received the CAE alone, Group B received the CAE and NHE, and group C received normal practice. Exclusions were high schools that did not respond, high schools that could not start at the appropriate time, and those which were absent from club activities for some reason.
Adverse events
None
Outcome measures
The intervention period was 16 weeks. Record sheets were distributed to athletes and recorded by individuals to record exercise compliance and injuries. Details of the injury were provided on the injury report form. However, the injury report was prepared with the advice of a trainer or physiotherapist. We investigated the frequency of groin pain and the number of days lost to soccer due to groin pain. Groin pain was classified into adductor-related pain, iliopsoas-related pain, inguinal-related pain, and pubic-related pain using the Doha classification, and the results tabulated. The definition of groin pain was defined as a condition in which pain occurs in the groin during sports activities, regardless of time loss or need for treatment, with reference to previous studies.7,24 The principal investigator explained the Doha classification method to the trainers and physiotherapists of each team and let them determine the type of groin pain for each athlete in pain.
The number of injuries and the injury rate indicates the frequency and probability of groin pain. The analysis was performed using an intention-to-treat (ITT) analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 27 | Day |
Last modified on
| 2021 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041938
