UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059093 |
|---|---|
| Receipt number | R000067598 |
| Scientific Title | A Survey on the Actual Conditions of Dysphagia Associated with Sarcopenia in Long-Term Care Health Facilities for the older adults and Exploration of Related Factors |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/10/02 21:53:16 |
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Basic information
Public title
A Survey on the Actual Conditions of Dysphagia Associated with Sarcopenia in Long-Term Care Health Facilities for the older adults and Exploration of Related Factors
Acronym
A survey on dysphagia associated with sarcopenia in long-term care facilities for the older adults
Scientific Title
A Survey on the Actual Conditions of Dysphagia Associated with Sarcopenia in Long-Term Care Health Facilities for the older adults and Exploration of Related Factors
Scientific Title:Acronym
A survey on dysphagia associated with sarcopenia in long-term care facilities for the older adults
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the prevalence of dysphagia associated with sarcopenia among elderly residents in long-term care health facilities and its associated factors.
Basic objectives2
Others
Basic objectives -Others
Analysis of the Relationship Between Swallowing Function and Pneumonia Incidence Among Residents of Long-Term Care Health Facilities for the older adults
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cross-sectional area of the Geniohyoid muscle, body composition, Food Intake LEVEL Scale, repeated saliva swallowing test
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Residents of Long-Term Care Health Facilities for the older adults
Key exclusion criteria
Persons for whom bioimpedance analysis is not feasible
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Kubo |
Organization
Shizuoka University
Division name
Faculty of Informatics, Department of Socio-Information Studies
Zip code
4328011
Address
3-5-1 Johoku, Chuo-ku, Hamamatsu-shi
TEL
+81(0)542371111
kubo-y@inf.shizuoka.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Kubo |
Organization
Shizuoka University
Division name
Faculty of Informatics, Department of Socio-Information Studies
Zip code
4328011
Address
3-5-1 Johoku, Chuo-ku, Hamamatsu-shi
TEL
+81(0)542371111
Homepage URL
kubo-y@inf.shizuoka.ac.jp
Sponsor or person
Institute
Shizuoka University
Institute
Department
Personal name
Funding Source
Organization
None
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
Shizuoka University
Address
3-5-1 Johoku, Chuo-ku, Hamamatsu-shi
Tel
+81(0)542371111
kubo-y@inf.shizuoka.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 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 09 | 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
Method
Basic attributes are collected from medical records.
Basic Attributes: Gender, age, height, weight, care level, primary admission diagnosis, medical history, presence of pacemaker, admission date, discharge date, dietary form, Hasegawa Dementia Scale Revised (HDS-R), Food Intake LEVEL Scale (FILS), Repetitive Saliva Swallowing Test (RSST), tongue pressure, grip strength, walking speed, Barthel Index, etc.
Data Collection: Conduct body composition analysis and echocardiography in the patient's room (approximately 5 minutes each). Body composition analysis and echocardiography are performed monthly after admission.
Management information
Registered date
| 2025 | Year | 09 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067598
