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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039407
Receipt No. R000044930
Scientific Title Effects of exercise with tongue training tool on the oral function of dementia patients living in nursing homes: a randomized open trial
Date of disclosure of the study information 2020/02/06
Last modified on 2020/02/06

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Basic information
Public title Effects of exercise with tongue training tool on the oral function of dementia patients living in nursing homes
Acronym Effects of exercise with tongue training tool on the oral function of dementia patients living in nursing homes
Scientific Title Effects of exercise with tongue training tool on the oral function of dementia patients living in nursing homes: a randomized open trial
Scientific Title:Acronym Effects of exercise with tongue training tool on the oral function of dementia patients living in nursing homes
Region
Japan

Condition
Condition dementia
Classification by specialty
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects of regular tongue training on oral frailty in dementia patients living in nursing homes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Maximum tongue pressure

* Assess the measured value at the screening and at four, eight, and 12 weeks after the start of training and calculate the amount of change from at the screening.
Key secondary outcomes 1. Repetitive saliva swallowing test (RSST)
2. Oral diadochokinetic (ODK) rate
3. Oral assessment
4. Geriatric Oral Health Assessment Index (GOHAI)

*1-4 Assess the measured value at the screening and at four, eight, and 12 weeks after the start of training and calculate the amount of change from at the screening.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Duration: 12 weeks
Intervention: Oral care program
Administration: dental brushing, tongue cleaning, and oral massage
Interventions/Control_2 Duration: 12 weeks
Intervention: Oral care program + Tongue training
Administration: In addition to oral care program, tongue training with Peko-panda (JMS Co., Ltd.) is performed twice a week, three sets of less than six times/set.
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 1. Subjects aged 65 or over who were diagnosed with dementia and were living in nursing homes where Medical Corporation Shinseikai involves in intraoral care

2. Subjects who are judged as eligible to participate in the study by the principal investigator

3. Subjects whose maximum tongue pressure is less than 30 kPa at screening (baseline)

4. If number of people whose maximum tongue pressure is less than 30 kPa at screening (baseline) exceed the sample size, select subjects with relatively low value in maximum tongue pressure
Key exclusion criteria 1. Subjects who are ineligibility to participate in the study based on the evaluation of the principal investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name HAMAJIMA
Organization Medical Corporation Shinseikai
Division name director
Zip code 331-0071
Address 266 Takagi, Nishi-ku, Saitama-shi, Saitama, Japan
TEL 048-625-7581
Email takuya-hamajima@shinsei-gr.com

Public contact
Name of contact person
1st name Naoko
Middle name
Last name SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization ORTHOMEDICO Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Kouyu Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization Takara Clinic Certified Review Board
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email CRB@takara-clinic.com

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs032190193
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人社団新聖会 (埼玉県) が口腔ケアを担当するグループホーム
The nursing homes where Medical Corporation Shinseikai (Saitama, Japan) involves in intraoral care

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 06 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 19 Day
Date of IRB
2019 Year 12 Month 03 Day
Anticipated trial start date
2020 Year 02 Month 29 Day
Last follow-up date
2021 Year 03 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
2020 Year 02 Month 06 Day
Last modified on
2020 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044930

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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