UMIN-CTR Clinical Trial

Basic information
Public title	Stretch intervention study for prevention of lumbar stress fracture in adolescent male soccer players
Acronym	Intervention study for prevention of lumbar stress fracture
Scientific Title	Stretch intervention study for prevention of lumbar stress fracture in adolescent male soccer players
Scientific Title:Acronym	Intervention study for prevention of lumbar stress fracture
Region	Japan

Condition
Condition	Lumbar stress fracture
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effect of stretching the Iliopsoas musles to prevent the lumbar stress fracture in adolescent soccer players.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Prevalance of lumbar stress fracture after the 5 months intervention of stretching the iliopsoas muscles.
Key secondary outcomes	The change of tightness of iliopsoas muscles after intervention of stretching for 5 months

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Stretching of Iliopsoas muscles for 5 months between the medical check up in spring and fall. Stretching menu is before and after the training,and before going to bed. Stretching time is total 80 seconds which is 10 seconds for each leg in 2 different ways,2 sets.
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	12 years-old <=
Age-upper limit	15 years-old >
Gender	Male
Key inclusion criteria	Adolescent soccer players who are aged 12-14years old and whose parents consented to the study.
Key exclusion criteria	Who has a health problem or diagnosed lumbar stress fracture before the intervention.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Sakae Middle name Last name Tanaka
Organization	Graduate School of Medicine,The University of Tokyo
Division name	Sensory & Motor System Medicine
Zip code	1130033
Address	7-3-1 Hongou,Bunkyou-ku,Tokyo
TEL	0338155411
Email	tanakas-ort@h.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Seira Middle name Last name Takei
Organization	Graduate School of Medicine,The University of Tokyo
Division name	Sensory & Motor System Medicine
Zip code	1130033
Address	7-3-1 Hongou,Bunkyou-ku,Tokyo
TEL	0338155411
Homepage URL
Email	saranaga0330@hotmail.com

Sponsor
Institute	Graduate School of Medicine,The University of Tokyo
Institute
Department

Funding Source
Organization	Graduate School of Medicine,The University of Tokyo
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Faculty of Sport Sciences, Waseda University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate School of Medicine,The University of Tokyo
Address	7-3-1 Hongou,Bunkyou-ku,Tokyo
Tel	0358410818
Email	ethics@m.u-tokyo.ac.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	早稲田大学スポーツ科学研究科（埼玉県）

Other administrative information
Date of disclosure of the study information	2019 Year 02 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	56
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Pandemic of COVID 19.
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	2019 Year 02 Month 06 Day
Date of IRB	2019 Year 04 Month 17 Day
Anticipated trial start date	2019 Year 04 Month 20 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 02 Month 06 Day
Last modified on	2022 Year 08 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040772