UMIN-CTR Clinical Trial

Basic information
Public title	The Development of Anthropometric and Physiological Profile of Elite Youth Soccer Players.
Acronym	The Development of Anthropometric and Physiological Profile of Elite Youth Soccer Players.
Scientific Title	The Development of Anthropometric and Physiological Profile of Elite Youth Soccer Players.
Scientific Title:Acronym	The Development of Anthropometric and Physiological Profile of Elite Youth Soccer Players.
Region	Japan

Condition
Condition	Improvement of muscle morphology and function by training.
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify how biological maturity and height variations contribute to the physical characteristics and motor abilities of youth elite soccer players, and to examine the effects of resistance training on physical characteristics and motor abilities.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	We conducted resistance training for lower muscles for 8 weeks. We measured muscle thickness and height of gluteus maximus and biceps femoris using ultrasound for physical evaluation. We measured repetition maximum, sprint, and agility ability for motor ability evaluation. We compare the training effects before and after the intervention.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	There is one intervention. 8 weeks of lower muscle resistance training for group A and B that have been allocated in advance. Resistance training with loading adjustment using a shaft is performed as resistance training for the lower limbs. After estimating 1 repetition maximum(1RM) each, three sets of 10RM squats are performed twice a week. Remeasure the 1RM once every two weeks and gradually increase the load.
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	13 years-old <=
Age-upper limit	13 years-old >=
Gender	Male
Key inclusion criteria	To be able to squat with a load that healthy and more than the weight of the shaft(10kg).
Key exclusion criteria	If the participant have an injury or disease impossible to conduct the research task before and during the research period.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Norikazu Middle name Last name Hirose
Organization	Faculty of Sport Sciences, Waseda University
Division name	Athletic training laboratory
Zip code	202-0021
Address	2-7-5 Higashifushimi, Nishitokyo-shi, Tokyo 202_0021, Japan
TEL	042-461-1322
Email	toitsu_hirose@waseda.jp

Public contact
Name of contact person	1st name Ryosuke Middle name Last name Itoh
Organization	Graduate School of Sport Science, Waseda University
Division name	Athletic training laboratory
Zip code	202-0021
Address	2-7-5 Higashifushimi, Nishitokyo-shi, Tokyo 202_0021, Japan
TEL	042-461-1322
Homepage URL
Email	itoh@fuji.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Office of Research Ethics Waseda University
Address	1-104 Totsuka-cho, Shinjuku-ku, Tokyo, Japan
Tel	03-5272-1639
Email	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	鹿島アントラーズつくばアカデミーセンター(茨城県)

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 01 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	No longer recruiting
Date of protocol fixation	2017 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2019 Year 09 Month 01 Day
Date of closure to data entry	2020 Year 04 Month 01 Day
Date trial data considered complete	2020 Year 04 Month 01 Day
Date analysis concluded	2020 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date	2017 Year 10 Month 26 Day
Last modified on	2019 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033907