UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051717 |
|---|---|
| Receipt number | R000059024 |
| Scientific Title | The effects of tongue cleaning for frailty prevention in individuals with intellectual disabilities on respiratory function and nutritional status |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2023/07/26 14:33:44 |
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Basic information
Public title
Effect of tongue cleaning on health of individuals with an intellectual disability
Acronym
Tongue cleaning and health in individuals with intellectual disabilities
Scientific Title
The effects of tongue cleaning for frailty prevention in individuals with intellectual disabilities on respiratory function and nutritional status
Scientific Title:Acronym
Tongue cleaning and frailty prevention in individuals with intellectual disabilities
Region
| Japan |
Condition
Condition
frailty
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The functional decline in individuals with intellectual disabilities is reported to be observed earlier, around the age of 40, compared to the general adult population, and then progresses rapidly. There is still a challenge in establishing frailty prevention measures for individuals with intellectual disabilities, which is considered desirable to begin during their young and middle-aged periods.
The applicants have previously reported that tongue cleaning along with regular oral care as a method of oral health management for elderly individuals requiring care not only improves the oral environment but also promotes improvement in respiratory function, which is a host factor, and enhances the secretion of ghrelin, a hormone that stimulates appetite.
This study aims to extend the healthy lifespan of individuals with intellectual disabilities and investigate the effects of tongue cleaning intervention for frailty prevention from a young to middle-aged period on respiratory function and nutritional status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Respiratory function at the end of one-year intervention period
Key secondary outcomes
Nutritional status at the end of one-year intervention period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Tongue cleaning with regular oral care after every meal for one year. Tongue cleaning involves brushing the dorsum of the tongue from the throat side towards the outside of the mouth, applying approximately 200 g of force, for a total of 10 strokes.
Interventions/Control_2
Regular oral care
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents of facilities for individuals with intellectual disabilities.
Key exclusion criteria
Individuals with wasting diseases including respiratory diseases.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Maya |
| Middle name | |
| Last name | Izumi |
Organization
Kyushu Dental University
Division name
School of Oral Health Sciences
Zip code
803-8580
Address
2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka
TEL
093-285-3102
r15izumi@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Sumio |
| Middle name | |
| Last name | Akifusa |
Organization
Kyushu Dental University
Division name
School of Oral Health Sciences
Zip code
803-8580
Address
2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka
TEL
093-285-3107
Homepage URL
r11akifusa@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu Dental University
Address
2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka
Tel
093-285-3107
r11akifusa@fa.kyu-dent.ac.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 01 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2023 | Year | 07 | Month | 26 | Day |
Last modified on
| 2023 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059024
