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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name