UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025383 |
|---|---|
| Receipt number | R000029212 |
| Scientific Title | The effect of oral exercise using solid food is chewy texture for improvement of the chewing and swallowing function in older people : pilot study |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2019/01/30 22:45:08 |
* 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
The effect of oral exercise using solid food is chewy texture for improvement of the chewing and swallowing function in older people : pilot study
Acronym
The effect of oral exercise program for improvement ofthe oral function in elderly
Scientific Title
The effect of oral exercise using solid food is chewy texture for improvement of the chewing and swallowing function in older people : pilot study
Scientific Title:Acronym
The effect of oral exercise program for improvement ofthe oral function in elderly
Region
| Japan |
Condition
Condition
Aspiration pneumonitis
Classification by specialty
| Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of study develops new oral exercise program using solid food is chewy texture for improvement of the chewing and swallowing function in older people.
We perform intervention study of preliminary investigation 1 sensory evaluation of solid foods is a chewy texture and preliminary investigation 2 inspect the effect of oral exercise using solid food is a chewy texture for improvement of the chewing and swallowing function in older people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Ability for chewing, lip pressure and tongue pressure, secretion amount of saliva, repetitive saliva swallowing test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
The participant receives oral exercises using solid food is a chewy texture three times a day before every meal for two weeks
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
2 1 The person who can express one's sense and impression
The person (including the person who put on dentures) that body function and oral status (inflammatory presence, teeth and a gingival state) is healthy
3 The person who can eat a chewing candy, a gum, a gummi candy, kombu, a dried cuttlefish
4 The person that the agreement in the document by the free will of study participants was obtained after enough understanding after having received enough explanation on participating of this study
5 The person who can train new oral exercises using solid food is a chewy texture while watching an image before every meal three times a day about preliminary investigation 2
Key exclusion criteria
1 The person who has been noted renal dysfunction from results of medical examination of the physician and the multiphasic health screening
2 The person who receives oral medicine and insulin injection for diabetes
3 The person who is diagnosed dementia or is noted possibility of the dementia from close relatives
4 The person with the symptom of the deglutition dysfunction that a gargle is not possible with the difficulty of swallowing
5 The person with implanting a false tooth and the filler of the teeth which seem to come off or the person that dentures are incompatible
6 The person with a history of jaw arthritis
7 The person with the disease in the cervical part
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawamura Atsuko |
Organization
Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences
Division name
Community / Gerontological Nursing
Zip code
Address
1-1-1-Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836222810
atsuko@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kawamura Atsuko |
Organization
Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences
Division name
Community / Gerontological Nursing
Zip code
Address
1-1-1-Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836222810
Homepage URL
atsuko@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
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
山口大学大学院医学系研究科保健学専攻
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 23 | Day |
Last modified on
| 2019 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029212
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
