UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063612 |
|---|---|
| Receipt number | R000072802 |
| Scientific Title | A cross-sectional study toward establishing reference data for neck muscle strength in healthy community-dwelling adults |
| Date of disclosure of the study information | 2026/11/12 |
| Last modified on | 2026/11/12 19:50:57 |
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Basic information
Public title
A study of age- and sex-related differences in neck muscle strength among healthy adults
Acronym
Neck Muscle Strength Study
Scientific Title
A cross-sectional study toward establishing reference data for neck muscle strength in healthy community-dwelling adults
Scientific Title:Acronym
Community Neck Strength Study
Region
| Japan |
Condition
Condition
Healthy community-dwelling adults aged 18 years or older
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate age- and sex-related differences in neck muscle strength among community-dwelling adults aged 18 years or older. It also examines the relationships between neck muscle strength, tongue pressure, and oral function. The findings are expected to provide reference data for future assessments of swallowing-related muscle function.
Basic objectives2
Others
Basic objectives -Others
The primary objective of this study is to characterize the age- and sex-specific distributions of neck muscle strength in healthy community-dwelling adults aged 18 years or older and to obtain preliminary reference data for clinical assessment. The secondary objectives are to assess maximum tongue pressure and oral function using the Oral Frailty 5-item Checklist (OF-5) and to explore their associations with neck muscle strength.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
The primary outcome is the age- and sex-specific distribution of neck flexor strength (kgf). Neck flexor strength will be measured three times in a seated position using the Cervical Dynamometer C-1 (Anima Corporation), and the maximum value will be used for analysis. Descriptive statistics, including mean, standard deviation, median, interquartile range, minimum, maximum, and 95% confidence interval of the mean, will be calculated by age group (18-39, 40-64, 65-74, and 75 years or older) and sex.
Key secondary outcomes
Secondary outcomes include maximum tongue pressure and oral function assessed using the Oral Frailty 5-item Checklist (OF-5). Maximum tongue pressure (kPa) will be measured three times using the JMS tongue pressure measurement device TPM-02, and the maximum value will be used to examine age- and sex-specific distributions. The association between neck flexor strength and maximum tongue pressure will be examined using Spearman's rank correlation coefficient. Oral function will be assessed using the OF-5, and the distribution of neck flexor strength according to oral function status will be explored.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Community-dwelling adults aged 18 years or older attending the Takasaki Food Education and Health Festa 2026.
2. Individuals who can eat and drink independently and maintain a stable sitting position.
3. Individuals who understand the study procedures and provide written informed consent voluntarily.
Key exclusion criteria
1. Individuals with a history of diseases affecting swallowing function or neck muscle strength, such as cerebrovascular or neuromuscular diseases.
2. Individuals with a history of surgery or radiotherapy affecting swallowing function or neck muscle strength.
3. Individuals with a history of diagnosis or treatment for dysphagia.
4. Individuals with oral, jaw, or neck pain or lesions that may interfere with measurements.
5. Individuals who have been medically advised to avoid strenuous exertion.
6. Individuals with acute symptoms such as fever.
7. Individuals deemed unsuitable for safe measurement by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | TETSURO |
| Middle name | |
| Last name | SAKAI |
Organization
Gunma Paz University
Division name
Department of Speech-Language-Hearing Therapy, Faculty of Rehabilitation
Zip code
3700006
Address
1-7-1 Toriyamachi, Takasaki City, Gunma
TEL
0273653366
t-sakai@paz.ac.jp
Public contact
Name of contact person
| 1st name | TETSURO |
| Middle name | |
| Last name | SAKAI |
Organization
Gunma Paz University
Division name
Faculty of Rehabilitation Department of Speech-Language-Hearing Sciences
Zip code
370006
Address
1-7-1 Toriyamachi, Takasaki City, Gunma
TEL
0273653366
Homepage URL
t-sakai@paz.ac.jp
Sponsor or person
Institute
Gunma Paz University
Institute
Department
Personal name
Funding Source
Organization
Gunma Paz University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Paz University
Address
1-7-1 Toriyamachi, Takasaki City, Gunma
Tel
0273653366
t-sakai@paz.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
| 2026 | Year | 11 | 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
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
| 2026 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, cross-sectional observational study involving healthy community-dwelling adults. Approximately 100 eligible adults aged 18 years or older will be recruited from attendees of the Takasaki Food Education and Health Festa 2026 on November 21, 2026, after obtaining written informed consent. Neck flexor strength and maximum tongue pressure will each be measured three times, and the maximum value will be used for analysis. Oral function will be assessed using the Oral Frailty 5-item Checklist (OF-5). Age- and sex-specific distributions of neck flexor strength will be described, and associations with tongue pressure and OF-5 findings will be explored. No therapeutic intervention or follow-up assessment will be conducted.
Management information
Registered date
| 2026 | Year | 11 | Month | 12 | Day |
Last modified on
| 2026 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072802
