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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014986
Receipt No. R000016935
Scientific Title Randomized, multicenter, open, two-arm parallel group trial of Oral myofunctional training for Clinical evidence to dementia.
Date of disclosure of the study information 2014/08/29
Last modified on 2019/12/30

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Basic information
Public title Randomized, multicenter, open, two-arm parallel group trial of Oral myofunctional training for Clinical evidence to dementia.
Acronym ORACLE trial for dementia
Scientific Title Randomized, multicenter, open, two-arm parallel group trial of Oral myofunctional training for Clinical evidence to dementia.
Scientific Title:Acronym ORACLE trial for dementia
Region
Japan

Condition
Condition dementia
Classification by specialty
Medicine in general Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the safety and efficacy of oral myofunctional training for dementia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes MMSE
Key secondary outcomes Background (gender, age, medical history, medication), response to calling the name, CDR-J, NPI-NH, Vitality Index, Barthel Index, GDS, PHQ9, Flow-mediated vasodiation (FMD), blood pressure, pulses, grip test, holter electrocardiography, adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Interventions) Oral myofunctional training (3 min, 5 times per day) program for 6 month
Interventions/Control_2 Control) Standard care and visiting 3 min, 5 times per day for 3 month, then start oral myofunctinlal training (3 min 5 times per day ) program for 3 month
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) Dementia person
2) Person whose MMSE score less than 24
Key exclusion criteria 1) Person who is mechanically ventilated
2) Person who has serious conditions in the oral cavity
3) In case the doctor finds any difficulty for participation
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Tomomi
Middle name
Last name Ide
Organization Kyushu University
Division name Graduate of Medical Sciences, Department of Cardiovascular Medicine
Zip code 8128582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-641-1151
Email tomomi_i@cardiol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Tomomi
Middle name
Last name Ide
Organization Kyushu University
Division name Graduate School of Medical Sciences
Zip code 8128582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-641-1151
Homepage URL
Email tomomi_i@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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 Clinical research network Fukuoka
Address 3-1-1, maidashi, Higashiku, Fukuoka
Tel 0926437171
Email mail@crnfukuoka.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 ・医療法人白十字会 介護老人保健施設 サン 施設長 石橋経久
〒857-1165 佐世保市大和町30番地 TEL 0956-33-7771

社会福祉法人 椿ヶ丘 特別養護老人ホーム椿ヶ丘荘 理事長 石司有理子
〒851-2404 長崎県長崎市神浦丸尾町1553 TEL 0959-24-0130

社会福祉法人 敬天会  牧島荘  理事長 栗林紘子
〒851-0114 長崎県長崎市牧島町9-1 TEL 095-837-0310

・社会福祉法人 白寿会 白寿荘 施設長 迎 正樹
〒858-0922 長崎県佐世保市鹿子前町904-1 TEL 0956-28-1181

医療法人秋桜会 介護老人保健施設 コスモスガーデン桜の里 
総括本部長 入口初則
〒851-2207 長崎県長崎市さくらの里2丁目27-28 TEL 095-840-1200

・燿光リハビリテーション病院 院長 大財 茂
〒857-0022 長崎県佐世保市山手町855-1 TEL 0956-25-3210

・社会福祉法人佐世保白寿会 介護保健施設 さざ・煌めきの里 施設長 牧山弘孝
〒857-0337 長崎県来た松浦郡佐々町八口免805-2 TEL 0956-41-1122

・社会医療法人財団 白十字会 介護老人保健施設 長寿苑 
施設長 長田 征三、苑長 南 祐三 
〒857-1151 長崎県佐世保市日宇町2835 TEL 0956-32-3800

介護老人保健施設カリタス
〒851-2322 長崎県長崎市西出津町67-5 TEL 0959-25-1555

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 29 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
2014 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 29 Day
Last follow-up date
2015 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 29 Day
Last modified on
2019 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016935

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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