UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029358 |
|---|---|
| Receipt number | R000033553 |
| Scientific Title | Verification of effect of oral frailty improvement program |
| Date of disclosure of the study information | 2017/09/30 |
| Last modified on | 2018/04/02 13:02:39 |
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Basic information
Public title
Verification of effect of oral frailty improvement program
Acronym
Verification of effect of oral frailty improvement program
Scientific Title
Verification of effect of oral frailty improvement program
Scientific Title:Acronym
Verification of effect of oral frailty improvement program
Region
| Japan |
Condition
Condition
Oral frailty
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of the Oral Flail Improvement Program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Improve oral function
Key secondary outcomes
Improve frailty (including frailty element)
Improvement of oral condition
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Oral gymnastics
Training of tongue movement
Pronunciation training
Mastication training
5 interventions in 3 months
30 minutes / times
Interventions/Control_2
Control
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who fall under the criteria of oral frilty
Key exclusion criteria
Participants have already been selected
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kikutani Takeshi |
Organization
The Nippon Dental University School of Life Dentistry
Division name
Department of Clinical Oral Rehabilitation
Zip code
Address
4-44-19 Higashi cho, Koganei city, Tokyo, Japan
TEL
042-316-6211
kikutani@tokyo.ndu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Watanabe Yutaka |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research on Social and Human Sciences
Zip code
Address
35-2 Sakaecho Itabashi-ku Tokyo, Japan
TEL
03-3964-1141
Homepage URL
ywata@tmig.or.jp
Sponsor or person
Institute
Kanagawa Dental Association
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Prefecture
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
歯科医院20施設（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | 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
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 29 | Day |
Last modified on
| 2018 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033553
| 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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