UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034471
Receipt number R000039310
Scientific Title The effects of learning using furniture on fatigue in children and adolescents.
Date of disclosure of the study information 2020/03/31
Last modified on 2019/04/26 13:55:09

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Basic information

Public title

The effects of learning using furniture on fatigue in children and adolescents.

Acronym

The relationship between learning environment of furniture and anti-fatigue.

Scientific Title

The effects of learning using furniture on fatigue in children and adolescents.

Scientific Title:Acronym

The relationship between learning environment of furniture and anti-fatigue.

Region

Japan


Condition

Condition

Healthy children and adolescents

Classification by specialty

Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of learning environment using furniture on fatigue in children and adolescents.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparisons of autonomic nerve function among standard desk, low desk and working counter desk.

Key secondary outcomes

Comparisons of cognitive function and Subjective fatigue among standard desk, low desk and working counter desk.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Cognitive work when sitting on a chair with standard desk.

Interventions/Control_2

Cognitive work when sitting on a floor with low desk.

Interventions/Control_3

Cognitive work when standing with a working counter desk.

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

10 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy children and adolescents from the 5th grade to 9th grade.

Key exclusion criteria

None

Target sample size

36


Research contact person

Name of lead principal investigator

1st name Yumiko
Middle name
Last name Kawasaki

Organization

Sekisui House, Ltd.

Division name

Comprehensive Housing R&D Institute Human Life R&D Institute

Zip code

531-0076

Address

15F, Tower East, UMEDA SKYBUILDING 1-88, Oyodonaka 1-chome Kita-ku, Osaka 531-0076, Japan

TEL

06-6440-3653

Email

ykawa@ga.sekisuihouse.co.jp


Public contact

Name of contact person

1st name Ikuto
Middle name
Last name Ueyama

Organization

Sekisui House, Ltd.

Division name

Comprehensive Housing R&D Institute Human Life R&D Institute

Zip code

531-0076

Address

15F, Tower East, UMEDA SKYBUILDING 1-88,Oyodonaka 1-chome Kita-ku, Osaka 531-0076, Japan

TEL

06-6440-3653

Homepage URL


Email

ueyama005@sekisuihouse.co.jp


Sponsor or person

Institute

Sekisui House, Ltd.

Institute

Department

Personal name



Funding Source

Organization

Sekisui House, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

RIKEN

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sekisui House, Ltd.

Address

6-6-4 Kabutodai, Kizugawa-shi, Kyoto 619-0224, JAPAN

Tel

0774-73-1125

Email

stanaka@gz.sekisuihouse.co.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

積水ハウス株式会社(大阪府)


Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 31 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

36

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

Completed

Date of protocol fixation

2018 Year 09 Month 06 Day

Date of IRB

2018 Year 09 Month 06 Day

Anticipated trial start date

2018 Year 10 Month 13 Day

Last follow-up date

2018 Year 10 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 12 Day

Last modified on

2019 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039310


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name