UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051333 |
|---|---|
| Receipt number | R000058533 |
| Scientific Title | Effectiveness of Pa-ta-ka-ra exercise to prevent frailty in community-dwelling older adults |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/12/13 16:43:40 |
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Basic information
Public title
Pa-ta-ka-ra exercise to prevent frailty
Acronym
Pa-ta-ka-ra exercise to prevent frailty
Scientific Title
Effectiveness of Pa-ta-ka-ra exercise to prevent frailty in community-dwelling older adults
Scientific Title:Acronym
Effectiveness of Pa-ta-ka-ra exercise to prevent frailty
Region
| Japan |
Condition
Condition
Older adults living in the community
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of oral health education in preventing frailty among community-dwelling older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of oral frailty and frailty after 1 and 3 months after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Oral health education program to prevent frailty
Interventions/Control_2
No intervention
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Older adults who do not need assistance in activities of daily living
Key exclusion criteria
People who do not agree to participate in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Yuki |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
060-0812
Address
N12W5, Kita-ku, Sapporo, Japan
TEL
011-706-3592
yukimck@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Miku |
| Middle name | |
| Last name | Izutsu |
Organization
Hokkaido University
Division name
Graduate School of Health Sciences
Zip code
060-0812
Address
Kita12, Nishi15, Kita-ku, Japan
TEL
011-706-3592
Homepage URL
yukimck@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Association of Health Care Initiative
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Hokkaido University Faculty of Health Sciences
Address
Kita12, Nishi15, Kita-ku, Japan
Tel
011-706-3316
shomu@hs.hokudai.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
| 2023 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2023 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058533
| 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 |
