UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057600 |
|---|---|
| Receipt number | R000065813 |
| Scientific Title | The Effect of Exercise Frequency in Tongue-Hold Swallowing on Tongue Pressure, Salivary Secretion, and Subjective Evaluations in Older Adults |
| Date of disclosure of the study information | 2025/04/12 |
| Last modified on | 2026/03/25 21:06:18 |
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Basic information
Public title
The Effect of Exercise Frequency in Tongue-Hold Swallowing on Tongue Pressure, Salivary Secretion, and Subjective Evaluations in Older Adults
Acronym
The Effect of Exercise Frequency in Tongue-Hold Swallowing on Tongue Pressure, Salivary Secretion, and Subjective Evaluations in Older Adults
Scientific Title
The Effect of Exercise Frequency in Tongue-Hold Swallowing on Tongue Pressure, Salivary Secretion, and Subjective Evaluations in Older Adults
Scientific Title:Acronym
The Effect of Exercise Frequency in Tongue-Hold Swallowing on Tongue Pressure, Salivary Secretion, and Subjective Evaluations in Older Adults
Region
| Japan |
Condition
Condition
NO
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the extent to which the training load of the tongue-hold swallow affects tongue pressure, salivary secretion, and subjective swallowing assessment in older adults.
Basic objectives2
Others
Basic objectives -Others
Evaluation of Differences Based on the Number of Trials per Session
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Tongue pressure
salivary volume
Key secondary outcomes
Oral frailty 5-item Checklist(OF-5)
Food Intake Level Scale(FILS)
Subjective evaluation of swallowing
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Tongue-Hold Swallow twice daily (5 times each) for 6 weeks Implementation group
Interventions/Control_2
Tongue-Hold Swallow twice daily (10 times each) for 6 weeks Implementation group
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
Able to independently consume three meals per day orally without the use of oral nutritional supplements(FILS is Level 7 or higher)
No major problems with daily activities
Key exclusion criteria
Patients with an underlying disease (cerebrovascular disease, head and neck cancer, etc.) that may cause dysphagia
Difficulty understanding Tongue-Hold Swallow instruction during initial evaluation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Kurachi |
Organization
International University of Health and Welfare Graduate School
Division name
Health and Welfare Sciences
Zip code
286-8686
Address
4-3 Kozunomori, Narita City, Chiba Prefecture
TEL
0476-20-7701
mkurachi@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Namiko |
| Middle name | |
| Last name | Otaki |
Organization
International University of Health and Welfare Graduate School
Division name
Health and Welfare Sciences
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo
TEL
03-5574-3900
Homepage URL
24S1022@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare Tokyo Akasaka District Ethics Committee
Address
4-1-26 Akasaka, Minato-ku, Tokyo
Tel
03-5574-3900
rinri-tky@iuhw.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
| 2025 | Year | 04 | Month | 12 | 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
26
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
| 2025 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 04 | Month | 12 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065813
