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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028513
Receipt No. R000032630
Scientific Title Effects of exciting activity to maintain or improve oral function in local older people
Date of disclosure of the study information 2020/05/08
Last modified on 2019/01/21

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Basic information
Public title Effects of exciting activity to maintain or improve oral function in local older people
Acronym Effects of exciting activity for local older people
Scientific Title Effects of exciting activity to maintain or improve oral function in local older people
Scientific Title:Acronym Effects of exciting activity for local older people
Region
Japan

Condition
Condition Aspiration pneumonia
Classification by specialty
Geriatrics Rehabilitation medicine Dental medicine
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study will evaluate the eating habit situation and masticatory power of local elderly people by questionnaire survey and chewing force measurement using xylitol chewing check gum.
Basic objectives2 Others
Basic objectives -Others We will evaluate the educational effect of swallowing and oral gymnastics in local elderly people.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The eating habits situation and the masticatory power of local elderly people
Key secondary outcomes Educational effect of swallowing and oral gymnastics

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Educational effect of swallowing and oral gymnastics
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
65 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria (1)Persons without problems in oral function (including those wearing dentures).
(2)A healthy elderly who lives in the area who got consent in writing about the participation of research.
Key exclusion criteria (1) A person who has difficulty communicating with others.
(2) A person with a history of temporomandibular joint disease.
(3) A person who is incompatible with a dental prosthesis and is easy for a denture to come off
(4) A person who can not obtain consent for participation in this research
(5) A person who can not chew gum.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kawamura Atsuko
Organization Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences
Division name Community / Gerontological Nursing
Zip code
Address 1-1-1-Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836222810
Email atsuko@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kawamura Atsuko
Organization Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences
Division name Community / Gerontological Nursing
Zip code
Address 1-1-1-Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836222810
Homepage URL
Email atsuko@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences, Community / Gerontological Nursing
Institute
Department

Funding Source
Organization Yamaguchi 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
Address
Tel
Email

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
2020 Year 05 Month 08 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 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 07 Day
Last follow-up date
2018 Year 01 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2019 Year 05 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 03 Day
Last modified on
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032630

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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