UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055800 |
|---|---|
| Receipt number | R000063779 |
| Scientific Title | Preliminary study on prevention of dysphagia in elderly dementia patients with sarcopenia due to wind whistle |
| Date of disclosure of the study information | 2024/10/11 |
| Last modified on | 2024/10/10 14:33:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Preliminary study on prevention of dysphagia in elderly dementia patients with sarcopenia due to wind whistle
Acronym
Preliminary study on dysphagia prevention
Scientific Title
Preliminary study on prevention of dysphagia in elderly dementia patients with sarcopenia due to wind whistle
Scientific Title:Acronym
Preliminary study on prevention of dysphagia in elderly dementia patients with sarcopenia due to wind whistle
Region
| Japan |
Condition
Condition
Sarcopenia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effect of maintaining tongue pressure by combining a winding whistle and medium-chain fatty acids in a dementia group home resident with sarcopenia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tongue pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
whistle
Interventions/Control_2
medium chain fatty acids
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Dementia group home residents aged 65 and over
(2) Ingestible
Key exclusion criteria
(1) Persons requiring care level 4 or higher
(2) Patients with severe stomatitis, pharyngeal cancer, tongue cancer, type I diabetes
(3) Others who are deemed inappropriate by the attending physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | naomi |
| Middle name | |
| Last name | ran |
Organization
Kanazawa Medical University
Division name
School of Nursing
Zip code
9200293
Address
1-1 1-1Daigaku,Uchinada,Kahoku,Ishikawa 920-0293,JAPAN
TEL
09094431552
ran@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | naomi |
| Middle name | |
| Last name | ran |
Organization
Kanazawa Medical University
Division name
School of Nursing
Zip code
9200293
Address
1-1 1-1Daigaku,Uchinada,Kahoku,Ishikawa 920-0293,JAPAN
TEL
09094431552
Homepage URL
ran@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
The Ethics Review Committee of Kanazawa Medical University
Address
1-1 1-1Daigaku,Uchinada,Kahoku,Ishikawa 920-0293,JAPAN
Tel
0762862211
ran@kanazawa-med.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 | 10 | Month | 11 | 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
33
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
| 2022 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 10 | Day |
Last modified on
| 2024 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063779
