UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035806 |
|---|---|
| Receipt number | R000040791 |
| Scientific Title | The Preventive Effect of the Nordic Hamstring Exercise and Physical Function Related to Hamstring Injuries in High School Soccer Players |
| Date of disclosure of the study information | 2019/02/07 |
| Last modified on | 2019/02/07 19:37:04 |
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Basic information
Public title
The Preventive Effect of the Nordic Hamstring Exercise and Physical Function Related to Hamstring Injuries in High School Soccer Players
Acronym
The Preventive Effect of the Nordic Hamstring Exercise and Physical Function Related to Hamstring Injuries in High School Soccer Players
Scientific Title
The Preventive Effect of the Nordic Hamstring Exercise and Physical Function Related to Hamstring Injuries in High School Soccer Players
Scientific Title:Acronym
The Preventive Effect of the Nordic Hamstring Exercise and Physical Function Related to Hamstring Injuries in High School Soccer Players
Region
| Japan |
Condition
Condition
Hamstring injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate whether physical examination variables correlate with hamstring injuries in high school soccer players and whether the NHE and its compliance rate affect the hamstring injury rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hamstring injury (27 weeks)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The intervention group performed Nordic hamstring exercise for 27 weeks.
Interventions/Control_2
The control group conducted regular training.
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
| 16 | years-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Male
Key inclusion criteria
Male soccer club members belonging to the top 16 schools of all 138 schools in Saitama Prefecture High School Football League in the previous season.
Key exclusion criteria
1. Who had hamstring injuries at the start of the study.
2. Who had a history of surgery in the lumbar spine or lower limbs at the time when consent was obtained.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Hasebe |
Organization
Saitama Medical University Graduate School
Division name
School of Medicine
Zip code
Address
981 Kawakado, Moroyama, Saitama, 350-0496 Japan
TEL
049-295-1001
hasebe_y@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyokazu Akasaka |
Organization
Saitama Medical University Graduate School
Division name
School of Medicine
Zip code
Address
981 Kawakado, Moroyama, Saitama, 350-0496 Japan
TEL
049-295-1001
Homepage URL
akasaka-smc@umin.ac.jp
Sponsor or person
Institute
Saitama Medical University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Graduate School
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
Address
Tel
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 | 02 | Month | 07 | 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
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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 07 | Day |
Last modified on
| 2019 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040791
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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