UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035460
Receipt number R000040399
Scientific Title Construction of medical screening system and prevention program for musculoskeletal problems in elementary and junior high school - intervention program with athletic trainer -
Date of disclosure of the study information 2019/01/06
Last modified on 2024/01/10 09:48:18

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Basic information

Public title

Construction of medical screening system and prevention program for musculoskeletal problems in elementary and junior high school - intervention program with
athletic trainer -

Acronym

intervention program for musculoskeletal problems in elementary and junior high school

Scientific Title

Construction of medical screening system and prevention program for musculoskeletal problems in elementary and junior high school - intervention program with
athletic trainer -

Scientific Title:Acronym

intervention program for musculoskeletal problems in elementary and junior high school

Region

Japan


Condition

Condition

musculoskeletal problems

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate actual conditions of musculoskeletal diseases of children in elementary and junior high school.
From the result, exercise instruction for prevention of exerciser disorder is implemented.
We will implement initiatives to prevent musculoskeletal function disorder and lead to the prevention of locomotive syndrome.

Basic objectives2

Others

Basic objectives -Others

medical screening

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

musculoskeletal conditions

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

Prevention

Type of intervention

Other

Interventions/Control_1

intervention program by athletic trainer

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

6 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

All

Key exclusion criteria

who can not tolerate exercise load
without consent

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name KAMADA

Organization

University of Tsukuba

Division name

Department of Orthopaedics surgery

Zip code

305-8575

Address

1-1-1 tennodai tsukuba

TEL

029-853-3219

Email

hkamada@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name KAMADA

Organization

University of Tsukuba

Division name

Department of Orthopaedics surgery

Zip code

305-8575

Address

1-1-1 tennnodai tsukuba

TEL

029-853-3219

Homepage URL


Email

hkamada@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

University of Tsukuba

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Tsukuba

Address

Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsuk

Tel

029-853-3210

Email

sien.igakuss@un.tsukuba.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



Other administrative information

Date of disclosure of the study information

2019 Year 01 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

Open public recruiting

Date of protocol fixation

2017 Year 05 Month 16 Day

Date of IRB

2017 Year 05 Month 16 Day

Anticipated trial start date

2017 Year 05 Month 16 Day

Last follow-up date

2032 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

As of 2023, the research is ongoing.


Management information

Registered date

2019 Year 01 Month 06 Day

Last modified on

2024 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040399


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name