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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029364
Receipt No. R000033504
Scientific Title The physical and mental impacts by "SAIKU" walking
Date of disclosure of the study information 2017/10/01
Last modified on 2017/10/01

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Basic information
Public title The physical and mental impacts by "SAIKU" walking
Acronym MEIWACHO "SAIKU" walking
Scientific Title The physical and mental impacts by "SAIKU" walking
Scientific Title:Acronym MEIWACHO "SAIKU" walking
Region
Japan

Condition
Condition Life habits related diseases
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the impacts of 1 hour walkng (3times a week for 3 months)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood examination (Red blood cells, Hb, Ht, Platelet, Triglyceride, HDL cholesterol, LDL cholesterol, AST, ALT, gamma-GTP, Fasting plasma sugar, HbA1c) before and after 3 months intervention
Key secondary outcomes Lifestyle habits, Self efficacy, 2 step test, Body measurements (Height, Weight, BMI, Waist circumference), Blood pressure, Uline examination (Uline sugar, Uline protein) before and after 3 months intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 1 hour walking (3times a week for 3 months)
Interventions/Control_2 Keep the same lifestyle habit without 1 hour walkng (3times a week for 3 months)
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
20 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adults
Key exclusion criteria People under a medical care for hypertension, diabetes and hyperlipidemia are principally excluded.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokazu Sabane
Organization JTB Corp.
Division name Corporate Planning Department Group Headquarters
Zip code
Address 3-1-4 Nihonbashi, Chuo, Tokyo
TEL 81-3-5290-1625
Email h_sabane217@j-medical-healthcare.com

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Sabane
Organization JTB Corp.
Division name Corporate Planning Department Group Headquarters
Zip code
Address 3-1-4 Nihonbashi, Chuo, Tokyo
TEL 81-3-5290-1625
Homepage URL
Email h_sabane217@j-medical-healthcare.com

Sponsor
Institute JTB Corp.
Institute
Department

Funding Source
Organization Meiwa-town
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor Japan Health & Research Institute
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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 01 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 09 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 02 Day
Last follow-up date
2019 Year 01 Month 01 Day
Date of closure to data entry
2019 Year 02 Month 01 Day
Date trial data considered complete
2019 Year 03 Month 01 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 01 Day
Last modified on
2017 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033504

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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