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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021771
Receipt No. R000025111
Scientific Title Effect verification test of body development shorts
Date of disclosure of the study information 2016/04/06
Last modified on 2016/04/11

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Basic information
Public title Effect verification test of body development shorts
Acronym Effect verification test of body development shorts
Scientific Title Effect verification test of body development shorts
Scientific Title:Acronym Effect verification test of body development shorts
Region
Japan

Condition
Condition Healthy adult women.
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 effective verification of development shorts by measuring 3D body, Motion analysis , Sitting pressure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes At the time of development of shorts worn,Subjectivity,3D Body,Motion analysis,Sitting pressure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Effectively verified in two kinds of intervention of shorts A and B.
Interventions/Control_2 Effectively verified in two kinds of intervention of shorts A and C.
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
65 years-old <=
Age-upper limit
74 years-old >=
Gender Female
Key inclusion criteria -Healthy Woman
-Those who are regular life
-under BMI30
-Those who can be attached to the waist of the activity meter in a continuous
Key exclusion criteria -Those who with a pain (such as low back pain knee pain, surgery in the past)
-Those Who pacemakers and metals (stent or clip) is in the body
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Niki Yoshifumi
Organization Kao Corporation
Division name R&D -Development Research- Personal Health Care Research Integrative Physiology Project.
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL 03-5630-9848
Email niki.yoshifumi@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Megumi Suzuki
Organization Kao Corporation
Division name R&D -Development Research- Personal Health Care Research Integrative Physiology Project.
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL 03-5630-9848
Homepage URL
Email suzuki.megumi@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Infoward inc.,Japan Women's University
Michiko Ohtsuka Lab.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 KU-2016-04-001
Org. issuing International ID_1 Infoward inc.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 花王株式会社東京研究所(東京都)、日本女子大学大塚美智子研究室(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 04 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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 07 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
2016 Year 04 Month 04 Day
Last modified on
2016 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025111

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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