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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035792
Receipt No. R000040772
Scientific Title Stretch intervention study for prevention of lumbar stress fracture in adolescent male soccer players
Date of disclosure of the study information 2019/02/06
Last modified on 2019/02/07

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

Public contact
1st name of contact person
1st name
Middle name
Last name Seira Takei
Organization Graduate School of Medicine,The University of Tokyo
Division name Sensory & Motor System Medicine
Zip code
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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 06 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=R000040772

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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