UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029364 |
|---|---|
| Receipt number | 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 09:56:52 |
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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
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
h_sabane217@j-medical-healthcare.com
Sponsor or person
Institute
JTB Corp.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033504
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
