UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055529 |
|---|---|
| Receipt number | R000063448 |
| Scientific Title | Effects of supine tuning exercises on muscles and posture involved in swallowing. |
| Date of disclosure of the study information | 2024/09/18 |
| Last modified on | 2024/09/18 13:05:22 |
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Basic information
Public title
Effects of supine tuning exercises on muscles and posture involved in swallowing.
Acronym
Influence of supine tuning exercises on swallowing and posture.
Scientific Title
Effects of supine tuning exercises on muscles and posture involved in swallowing.
Scientific Title:Acronym
Influence of supine tuning exercises on swallowing and posture.
Region
| Japan |
Condition
Condition
Aging
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of supine tuning exercises on the muscles and posture involved in swallowing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of swallowing function 2 weeks after the start of supine tuning exercises.
Key secondary outcomes
Height, weight, swallowing frequency, grip strength, sit and reach, sit-ups, respiratory function (vital capacity, FEV1/FVC), center of gravity (balance assessment), G-sensor, body composition, grip-and-release test (dexterity), walk test, finger ring test (frailty assessment), postural assessment, questionnaire survey (lifestyle, cognitive function), contrast swallowing test, tongue pressure, oral opening strength, gum test, oral diadochokinesis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Supine tuning exercise (During 2 weeks, every morning)
Interventions/Control_2
Exercises for head, neck, lips and pharynx and abdominal breathing (During 2 weeks, every morning)
Interventions/Control_3
Control
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Males and females older than 75 years, 30 in total number
Key exclusion criteria
Persons who routinely perform exercises in the supine position.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Fujita |
Organization
Teikyo University
Division name
Faculty of medical technology
Zip code
192-0395
Address
359 Otsuka, Hachioji, Tokyo
TEL
0426783967
fujita.eri.rj@teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Fujita |
Organization
Teikyo University
Division name
Faculty of medical technology
Zip code
192-0395
Address
359 Otsuka, Hachioji, Tokyo
TEL
0426783967
Homepage URL
fujita.eri.rj@teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Daiwa Securities Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Woman's Christian University
Address
2-6-1 Zempukuji, Suginami-ku, Tokyo
Tel
03-5382-6912
irb_office@gr.twcu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NDU-T2024-12
Org. issuing International ID_1
The Nippon Dental University
Study ID_2
24-059
Org. issuing International ID_2
Teikyo University
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 18 | 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
| 2024 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 09 | 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 | 09 | Month | 18 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063448
