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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025383
Receipt No. 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

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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
Email 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
Email atsuko@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

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
Email

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
URL(English) https://upload.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


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