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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028394
Receipt No. R000032504
Scientific Title Effect of oral functional training on immunological abilities of older people
Date of disclosure of the study information 2017/07/27
Last modified on 2017/07/27

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Basic information
Public title Effect of oral functional training on immunological abilities of older people
Acronym Influence of oral functional training and immune function
Scientific Title Effect of oral functional training on immunological abilities of older people
Scientific Title:Acronym Influence of oral functional training and immune function
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Nursing Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to investigate the potential using of IgA in saliva to evaluate the effect of oral functional exercise on highly elderly persons whose age were more than 80.
Basic objectives2 Others
Basic objectives -Others Sex, age, BMI, dietary habit, oral cavity environment, number of cold-affected cases in the past year, past aspiration pneumonia history
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Between July 20 th - 20 th September 25 saliva was collected as preliminary data three times, then oral function gymnastics were performed before each meal, saliva was collected 3 weeks, 6 weeks later, saliva secretion amount, saliva IgA was measured.
Key secondary outcomes Basic attributes (gender, age) BMI, content on diet, oral cavity environment, number of cold-affected times in the past year, past aspiration pneumonia history was investigated.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 The intervention period (3 times a day, before meals, 6 weeks), the amount of intervention (once 3 minutes), the number of interventions (3 times per day) / no intervention period Three saliva collected in 2 weeks
Oral exercise including massage of large salivary glands./ Individual custom before intervention
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
80 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Those who have moved to the same elderly health care facility and are almost self-supporting ADL, those who got consent to research among those who can judge on their own
Key exclusion criteria Those with a declining consciousness level, those who can not take oral, those who are in daily life with full assistance situation, those who can not self-judge, those who are not in dental treatment
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsue Sato
Organization Tohto College of Health Sciences
Division name Nursing Science, Human Care Department
Zip code
Address 2-4-11 kamisibatyo west, Fukaya City , Saitama Prefecture
TEL 048-574-2500
Email mitsue.sato@tohto.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsue Sato
Organization Tohto College of Health Sciences
Division name Nursing Science,Human Care Department
Zip code
Address 4-2-11 Nishi, Kamishiba-cho, Fukaya-shi, Saitama Prefecture 366-0052
TEL 048-574-2500
Homepage URL
Email mitsue.sato@tohto.ac.jp

Sponsor
Institute Tohto College of Health Sciences , and Oasis for Long-term Care Health Facility for the Elderly
Institute
Department

Funding Source
Organization Tohto Medical College Individual Research Fee
Organization
Division
Category of Funding Organization Other
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 介護老人保健施設オアシス(神奈川県)、

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 27 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
2013 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 27 Day
Last follow-up date
2014 Year 12 Month 25 Day
Date of closure to data entry
2015 Year 02 Month 25 Day
Date trial data considered complete
2015 Year 03 Month 25 Day
Date analysis concluded
2015 Year 03 Month 25 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 27 Day
Last modified on
2017 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032504

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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