UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034382 |
|---|---|
| Receipt number | R000039184 |
| Scientific Title | The physical and mental impacts by "Tamano" health promotion program |
| Date of disclosure of the study information | 2018/10/05 |
| Last modified on | 2018/10/04 19:35:51 |
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Basic information
Public title
The physical and mental impacts by "Tamano" health promotion program
Acronym
"TAMANO" health promotion program
Scientific Title
The physical and mental impacts by "Tamano" health promotion program
Scientific Title:Acronym
"TAMANO" health promotion program
Region
| Japan |
Condition
Condition
Life habits related diseases
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impacts of health promotion program (2 times a week for 3 months)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor functions before and after 3 months intervention
Key secondary outcomes
Body measurements (Height, Weight, BMI, Waist circumference), Blood pressure, Blood glucose, Lifestyle habits, Self efficacy, Subjective health status, mood states before and after 3 months intervention
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
24 classes of healthy promotion program (2 times a week for 3 months)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Who are prohibited to exercise
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyoshi Takahashi |
Organization
JTB Corp.
Division name
Health Tourism Institute
Zip code
Address
3-1-4 Nihonbashi, Chuo, Tokyo
TEL
81-3-5290-1625
n_takahashi040@j-medical-healthcare.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyoshi Takahashi |
Organization
JTB Corp.
Division name
Health Tourism Institute
Zip code
Address
3-1-4 Nihonbashi, Chuo, Tokyo
TEL
81-3-5290-1625
Homepage URL
n_takahashi040@j-medical-healthcare.com
Sponsor or person
Institute
Tamano City
Institute
Department
Personal name
Funding Source
Organization
Tamano City
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2018 | Year | 10 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 04 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039184
| 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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