UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028394
Receipt number 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 11:01:17

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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