UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019849 |
|---|---|
| Receipt number | R000022930 |
| Scientific Title | An observational study of physical function in healthy Japanese. |
| Date of disclosure of the study information | 2015/11/19 |
| Last modified on | 2015/12/04 09:14:27 |
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Basic information
Public title
An observational study of physical function in healthy Japanese.
Acronym
An observational study of physical function in healthy Japanese.
Scientific Title
An observational study of physical function in healthy Japanese.
Scientific Title:Acronym
An observational study of physical function in healthy Japanese.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the age-related changes of physical function in healthy Japanese
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Physical functions
2.Motor unit activity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-A person who doesn't have a motor dysfunction.
-A person who doesn't use a cardiac pacemaker and/or an artificial joint.
Key exclusion criteria
-A person who had locomotive organ injury such as fracture, tendon rupture, muscle strain in the last 1 year.
-A person who had been collected the blood more than 200 mL or 400 mL, within one month or three months before this study.
-A person who are not eligible due to physician's judgment.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Shimotoyodome |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7589
shimotoyodome.akira@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoko Soga |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7828
Homepage URL
soga.satoko@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
The University of Electro-Communications
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
医療法人北斗会宇都宮東病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 01 | Day |
Other
Other related information
-Design and Setting: A randomized double-blind controlled trial was performed at Tochigi, Japan.
-Measurements: Physical functions such as knee extension strength, side step count, and chair stand time.
-Measure the amount of activity using portable activity meter for 2 weeks
-->health examination and evaluation of physical functions.
Management information
Registered date
| 2015 | Year | 11 | Month | 18 | Day |
Last modified on
| 2015 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022930
