UMIN-CTR Clinical Trial

Basic information
Public title	The effects of mouse exercise program on oral function in the elderly
Acronym	The effects of mouse exercise program on oral function in the elderly
Scientific Title	The effects of mouse exercise program on oral function in the elderly
Scientific Title:Acronym	The effects of mouse exercise program on oral function in the elderly
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	"Oral Exercise Program" for the elderly and its effect on oral fuction
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Occlusal force and occlusal contact area test Gum for check of chewing Oral moisture Swallowing screening questionnaire Tongue pressure test Tongue and lip movement function Hirai-style intake available food questionnaire Height, weight, and BMI Intraoral examination
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	Food Behavior,custom
Interventions/Control_1	Mouse exercise program
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Individuals who are able to exercise their mouths (2) Subjects giving written informed consent
Key exclusion criteria	(1)Individuals with symptoms that may affect mouth exercise or gum chewing (2)Individuals may develop allergies in relation to the test (3) Individuals who are judged by the principal investigator to be inappropriate for participation in this study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Osawa
Organization	Lotte Co., Ltd.
Division name	Central Laboratory, Kamukoto Research Department
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0744
Email	oosawa_kenji@lotte.co.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Osawa
Organization	Lotte Co., Ltd.
Division name	Central Laboratory, Kamukoto Research Department
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0744
Homepage URL
Email	oosawa_kenji@lotte.co.jp

Sponsor
Institute	Lotte Co., Ltd.
Institute
Department

Funding Source
Organization	Lotte Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiba Palace Clinic
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel	03-5408-1590
Email	jimukyoku@mail.souken-r.com

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 10 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	64
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	2021 Year 08 Month 23 Day
Date of IRB	2021 Year 08 Month 23 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2022 Year 05 Month 12 Day
Date of closure to data entry	2022 Year 05 Month 12 Day
Date trial data considered complete	2022 Year 05 Month 31 Day
Date analysis concluded	2022 Year 06 Month 23 Day

Other
Other related information

Management information
Registered date	2021 Year 09 Month 09 Day
Last modified on	2022 Year 09 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051861