UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044634
Receipt number R000050985
Scientific Title Effects of long-term care prevention and disaster prevention measures programs for the elderly in the community
Date of disclosure of the study information 2021/06/23
Last modified on 2021/06/23 18:18:13

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Basic information

Public title

Effects of long-term care prevention and disaster prevention measures programs for the elderly in the community

Acronym

Effects of long-term care prevention and disaster prevention measures programs for the elderly in the community

Scientific Title

Effects of long-term care prevention and disaster prevention measures programs for the elderly in the community

Scientific Title:Acronym

Effects of long-term care prevention and disaster prevention measures programs for the elderly in the community

Region

Japan


Condition

Condition

Elderly people over 65 years old

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examining the effects of long-term care prevention and disaster prevention measures programs for the elderly aged 65 and over

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Physical fitness and cognitive function

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Lower limb muscle exercise
Lecture on long-term care prevention and disaster prevention measures

Twice a month
1 year

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Elderly people aged 65 and over living in the target area
2.Those who participate in the long-term care prevention / disaster prevention measures program
3.Those who have obtained written consent for participation in the research

Key exclusion criteria

1.Those who are prohibited from participating in this program by a doctor
2.People who cannot walk on their own
3.Person who is certified as requiring long-term care

Target sample size

600


Research contact person

Name of lead principal investigator

1st name Tokiko
Middle name
Last name Isowa

Organization

Mie University

Division name

Graduate School of Medicine

Zip code

514-8507

Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

0592315258

Email

tisowa@med.mie-u.ac.jp


Public contact

Name of contact person

1st name Tokiko
Middle name
Last name Isowa

Organization

Mie University

Division name

Graduate School of Medicine

Zip code

514-8507

Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

0592315258

Homepage URL


Email

tisowa@med.mie-u.ac.jp


Sponsor or person

Institute

Mie University

Institute

Department

Personal name



Funding Source

Organization

Ministry of education

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

The Clinical Research Ethics Review Committee of Mie University Hospital

Address

2-174 Edobashi, Tsu, Mie, Japan

Tel

059-231-5045

Email

kk-sien@med.mie-u.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

2021 Year 06 Month 23 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

Preinitiation

Date of protocol fixation

2021 Year 06 Month 06 Day

Date of IRB


Anticipated trial start date

2021 Year 07 Month 20 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 06 Month 23 Day

Last modified on

2021 Year 06 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050985


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name