UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of oral exercise using solid food is chewy texture for improvement of the chewing and swallowing function in older people : pilot study
Title of the study (Brief title)	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	Kawamura Atsuko
Organization	Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences
Division name	Community / Gerontological Nursing
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	Kawamura Atsuko
Organization	Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences
Division name	Community / Gerontological Nursing
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029212