UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055151 |
|---|---|
| Receipt number | R000063004 |
| Scientific Title | Development and understanding of characteristics of exercises to prevent recurrence of groin pain |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2025/10/10 15:19:18 |
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Basic information
Public title
Exercise intervention to prevent recurrence of groin pain
Acronym
Exercise Interventions to Prevent Recurrence for Athletes with Groin Pain
Scientific Title
Development and understanding of characteristics of exercises to prevent recurrence of groin pain
Scientific Title:Acronym
Development of exercises to prevent recurrence of groin pain
Region
| Japan |
Condition
Condition
Groin pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of exercise on athletes with a history of groin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of cases of groin pain from intervention date to week 28
Key secondary outcomes
Biomechanical measurements include three-dimensional coordinate data, muscle activity, and three-dimensional ground reaction force data during change of direction and kick motion.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Exercises are included in the warm-up. The frequency of intervention for the athletes is 3 times per week. Exercises related to improving thorax mobility include 2 sets of 6 clock exercises, 2 sets of 6 low row exercises, 2 sets of 6 world greatest, 2 sets of 8 trunk rotation exercises, and 2 sets of 12 retraction exercises. Exercises related to improving trunk stability include 10 draw-in, 2 sets of 8 birddog, 2 sets of 8 palloff-press exercises, and 2 sets of 12 deadbugs. Exercises to improve pelvic rotation: Cat and Dog 12 x 2 sets, Twist Lunges 10 x 2 sets. Pelvic stability exercises: 10 overhead squats, 1 minute of side plank exercises, 2 sets of 12 hip hitch exercises, and 10 Copenhagen hip adduction exercises. Exercises related to hip mobility: 5 hip rotation stretches for 30 seconds, 5 anterior thigh stretches for 30 seconds, 5 posterior thigh stretches for 30 seconds, and 6 shoulder insertions.
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Male and female students who participate in club activities and play sports on a daily basis.
Key exclusion criteria
If the patient is unable to give written consent to participate in this study.
The student is unable to begin the study due to other injuries at the time of the study's initiation.
Is unable to participate in practice due to academic or other reasons at the time of study entry.
The athlete has groin pain and is undergoing treatment at the time of the start of the study.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Norikazu |
| Middle name | |
| Last name | Hirose |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
202-0021
Address
3-4-1 Higashifushimi, Nishitokyo-shi, Tokyo
TEL
042-451-1022
toitsu_hirose@waseda.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Saito |
Organization
Waseda University
Division name
Graduate School of Sport Sciences
Zip code
202-0021
Address
Room 208, Bldg. 75-2, Higashifushimi Campus, Waseda University, 2-7-5 Higashifushimi, Nishi-Tokyo,
TEL
042-461-1322
Homepage URL
10jajicii01@fuji.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University Open Innovation Ecosystem Program, for Pioneering Research
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
Ethics Review Procedures concerning Research with Human Subjects
Address
1-104 Totsukacho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2024 | Year | 08 | Month | 06 | 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
38
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 03 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063004
