UMIN-CTR Clinical Trial

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