UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035792
Receipt number 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 2022/08/19 14:22:06

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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

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 or person

Institute

Graduate School of Medicine,The University of Tokyo

Institute

Department

Personal name



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

Value
https://center6.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