UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038094
Receipt number R000043412
Scientific Title Effect of masticatory ability on physical function and outcome of the long-term care prevention program in elderly people
Date of disclosure of the study information 2019/09/25
Last modified on 2024/01/20 11:26:48

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Basic information

Public title

Effect of masticatory ability on physical function and outcome of the long-term care prevention program in elderly people

Acronym

Effect of masticatory ability on physical function and outcome of the long-term care prevention program in elderly people

Scientific Title

Effect of masticatory ability on physical function and outcome of the long-term care prevention program in elderly people

Scientific Title:Acronym

Effect of masticatory ability on physical function and outcome of the long-term care prevention program in elderly people

Region

Japan


Condition

Condition

healthy elderly

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of the study is to investigate the correlation between masticatory ability and physical function or fall risks in healthy elderly people. The effect of masticatory ability on the outcome of the long-term care prevention program will be also examined.

Basic objectives2

Others

Basic objectives -Others

We will try to develope a system for evaluating fall risks among elderly people based on the masticatory ability. The utility of the system in estimating the effect of the long-term care prevention program on the physical function will be also examined.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

frequency of falling

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

65 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Living in Osaka City

Key exclusion criteria

People who are difficult to walk by themselves (regardless of the use of walk aid)/Oral disorder (regardless of the use of prosthetic tooth)

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Hisayo
Middle name
Last name Yokoyama

Organization

Osaka City University Graduate School of Medicine

Division name

Environmental Physiology for Exercise

Zip code

558-8585

Address

3-3-138, Sugimoto, Sumiyoshi-ku, Osaka City

TEL

0666052947

Email

yokoyama@sports.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Hisayo
Middle name
Last name Yokoyama

Organization

Osaka City University Graduate School of Medicine

Division name

Environmental Physiology for Exercise

Zip code

558-8585

Address

3-3-138, Sugimoto, Sumiyoshi-ku, Osaka City

TEL

0666052947

Homepage URL


Email

yokoyama@sports.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

Institutional Review Board of Osaka City University Graduate School of Medicine

Address

1-2-7-601, Asahi-Machi, Abeno-ku, Osaka City

Tel

0666453456

Email

ethics@med.osaka-cu.ac.jp


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



Other administrative information

Date of disclosure of the study information

2019 Year 09 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.osakagas.co.jp/company/efforts/fukushi/jyosei/kenkyu_kako21.html

Number of participants that the trial has enrolled

136

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

Main results already published

Date of protocol fixation

2019 Year 08 Month 22 Day

Date of IRB

2019 Year 08 Month 22 Day

Anticipated trial start date

2019 Year 11 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Measurements
1. masutocatory ability: how fine the gummi candy was crashed after 30 chewings
2. other oral functions: oral diadochokinesis, number of the existing tooth
3. physical functions: grip power, quadriceps muscle strength, one-leg standing time, functional reach, Timed Up and Go
4. anthropometry: body height, body weight, body mass index, body fat mass, lean body mass
5. events of falling, objective risk factor for falling, activity of daily life using a questionnaire
6. Food Frequency Questionnaire


Management information

Registered date

2019 Year 09 Month 25 Day

Last modified on

2024 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043412


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name