UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042530 |
|---|---|
| Receipt number | R000048331 |
| Scientific Title | Development of the tailor-made health program appropriated to the health condition of the elderly : (2) A declining tendency of the knee function |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2023/07/17 15:37:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of the tailor-made health program appropriated to the health condition of the elderly : (2) A declining tendency of the knee function
Acronym
Development of the health program for the elderly (2)
Scientific Title
Development of the tailor-made health program appropriated to the health condition of the elderly : (2) A declining tendency of the knee function
Scientific Title:Acronym
Development of the health program for the elderly (2)
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create a convenient reference value for the health condition of the elderly and develop the tailor-made health program which based on that reference value
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
physical function test, cognitive function test, sleep status questionnaire, and psychological status questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Maslinic acid intake + exercise group
Interventions/Control_2
Placebo intake + exercise group
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals who aged 65-90 years
2) Individuals who are not forbidden from exercising by doctor
3) Individuals who can visit the implementation place of this study on their own
Key exclusion criteria
1) Individuals who are undergoing rehabilitation at orthopedic surgery due to disorders of knees
2) Individuals who have paralysis
3) Individuals who are sensitive to test products
4) Individuals who are participating or have been participated within 3 month in other clinical study
5) Individuals who are recognized unsuitable for this study by the the principal investigator
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Okura |
Organization
University of Tsukuba
Division name
Faculty of Health and sport science
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-029-853-2733
okura.tomohiro.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Jieun |
| Middle name | |
| Last name | Yoon |
Organization
University of Tsukuba
Division name
R&D Center for Tailor-Made QOL
Zip code
305-8550
Address
1-2, kasuga, Tsukuba, Ibaraki, Japan
TEL
+81-029-839-1593
Homepage URL
yoon.jieun.fu@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
NIPPON FLOUR MILLS Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Faculty of Health and sport science Ethics Committee
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
+81-029-853-2571
hitorinri@un.tsukuba.ac.jp
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
| 2021 | Year | 09 | Month | 30 | 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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048331
