UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059323 |
|---|---|
| Receipt number | R000067703 |
| Scientific Title | Paralel group comparison analysis of effect of distribution of tongue muscle activity during various tongue resistance training on muscle mass and function |
| Date of disclosure of the study information | 2025/10/30 |
| Last modified on | 2025/10/01 17:49:27 |
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Basic information
Public title
Paralel group comparison analysis of effect of distribution of tongue muscle activity during various tongue resistance training on muscle mass and function
Acronym
Effect of distribution of tongue muscle activity during various tongue resistance training on muscle mass and function
Scientific Title
Paralel group comparison analysis of effect of distribution of tongue muscle activity during various tongue resistance training on muscle mass and function
Scientific Title:Acronym
Effect of distribution of tongue muscle activity during various tongue resistance training on muscle mass and function
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effects of different training methods on the distribution of tongue muscle activity during training exercises by measuring the distribution of tongue muscle activity before and after performing tongue pressure training with varying loads and repetitions.
Basic objectives2
Others
Basic objectives -Others
This study measures changes in the distribution of tongue muscle activity during training exercises, muscle volume, and swallowing-related functions before and after performing tongue pressure training with varying loads and repetitions. Furthermore, by also measuring the distribution of tongue muscle activity during various swallowing-related functions, it aims to elucidate the effects of different training methods on the distribution of tongue muscle activity and swallowing-related functions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution of tongue muscle activity during training exercises
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
tongue elevation exercises 10 times for 3 sets, 3 times a week, for 4 weeks.
Interventions/Control_2
tongue elevation exercises and lateral exercises alternately for one week each, 10 reps per set, 3 sets per session, 3 times per week for 4 weeks.
Interventions/Control_3
tongue elevation exercises 10 times for 3 sets, 3 times a week, for 8 weeks.
Interventions/Control_4
tongue elevation exercises 10 times for 3 sets, every day, for 4 weeks.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy individuals recruited through poster advertisements
20 years old >
Individuals for whom written consent to participate in the research has been obtained
Key exclusion criteria
Individuals with apparent functional abnormalities in the jaw and oral cavity
Individuals with pain originating from teeth or periodontal tissues, or with neurological, muscular, or metabolic disorders
Individuals for whom MRI is contraindicated
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | satoshi |
| Middle name | |
| Last name | yamaguchi |
Organization
Tohoku University Graduate School of Dentistry
Division name
Aging and Geriatric Dentistry
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku,Sendai,Miyagi, Japan
TEL
022-717-8396
satoshi.yamaguchi.a3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | masahiro |
| Middle name | |
| Last name | sato |
Organization
Tohoku University Graduate School of Dentistry
Division name
Aging and Geriatric Dentistry
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku,Sendai,Miyagi, Japan
TEL
022-717-8396
Homepage URL
masahiro.kosugi.b5@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Tohoku University Graduate School of Dentistry
Address
4-1 Seiryo-machi, Aoba-ku,Sendai,Miyagi, Japan
Tel
022-717-8396
masahiro.kosugi.b5@tohoku.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 | 10 | Month | 30 | 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
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | 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 | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067703
