UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045102 |
|---|---|
| Receipt number | R000051527 |
| Scientific Title | Proposal / dissemination and verification of coronafrail prevention for the older adults loving in the community. |
| Date of disclosure of the study information | 2021/08/09 |
| Last modified on | 2022/02/08 09:24:28 |
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Basic information
Public title
Establishment of preventive methods for
physical fitness and cognitive decline in
the older adults during COVID-19 pandemic.
Acronym
Establishment of a preventive method for
physical and cognitive decline during COVID-19 pandemic.
Scientific Title
Proposal / dissemination and verification of coronafrail prevention for the older adults loving in the community.
Scientific Title:Acronym
Establishment of corona frail prevention
method.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the physical and mental effects of task performance by community-dwelling older people during COVID-19 pandemic
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty index, locomo degree, depression degree before and after the survey
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Work on the tasks listed in the daily calendar for 3 months.
Interventions/Control_2
No tasks performed 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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy subjects in community
2.Person who provides informed consent by a document.
Key exclusion criteria
Nothing
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Misa |
| Middle name | |
| Last name | Nakamura |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
597-0104
Address
Mizuma 158, Kaizuka City, Osaka, Japan
TEL
072-446-6700
nakamuram@kawasakigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Misa |
| Middle name | |
| Last name | Nakamura |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
597-0104
Address
Mizuma 158, Kaizuka City, Osaka, Japan
TEL
072-446-6700
Homepage URL
nakamuram@kawasakigakuen.ac.jp
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
Funding Source
Organization
Osaka Kawasaki Rehabilitation University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Kawasaki Rehabilitation University
Address
Mizuma 158, Kaizuka City, Osaka, Japan
Tel
072-446-6700
nakamuram@kawasakigakuen.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 | 08 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 09 | Day |
Last modified on
| 2022 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051527
| 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 |
