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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035806
Receipt No. R000040791
Official scientific title of the study 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

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Basic information
Official scientific title of the study The Preventive Effect of the Nordic Hamstring Exercise and Physical Function Related to Hamstring Injuries in High School Soccer Players
Title of the study (Brief title) 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 Yuki Hasebe
Organization Saitama Medical University Graduate School
Division name School of Medicine
Address 981 Kawakado, Moroyama, Saitama, 350-0496 Japan
TEL 049-295-1001
Email hasebe_y@saitama-med.ac.jp

Public contact
Name of contact person Kiyokazu Akasaka
Organization Saitama Medical University Graduate School
Division name School of Medicine
Address 981 Kawakado, Moroyama, Saitama, 350-0496 Japan
TEL 049-295-1001
Homepage URL
Email akasaka-smc@umin.ac.jp

Sponsor
Institute Saitama Medical University Graduate School
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040791

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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