UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028057
Receipt number R000032123
Scientific Title Study of prevention for dementia and frailty people in community
Date of disclosure of the study information 2017/08/01
Last modified on 2020/05/21 17:49:46

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Basic information

Public title

Study of prevention for dementia and frailty people in community

Acronym

Prevention for dementia and frailty

Scientific Title

Study of prevention for dementia and frailty people in community

Scientific Title:Acronym

Prevention for dementia and frailty

Region

Japan


Condition

Condition

Community dwelling elderly

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study to investigate to relevant factors for frailty and mild cognitive impairment that is preminaly stage of dementia.

Basic objectives2

Others

Basic objectives -Others

Investigate to relevant factors

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

cognitive functions
physical functions

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

Person are obtained consent

Key exclusion criteria

Those who is needed long-term care or already diagnosis of dementia.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kohei Maruya

Organization

Saitama medical university

Division name

Department of physical therapy, Faculty of health and medical care

Zip code


Address

981, Kawakado, Moroyama-town, Iruma-gun, Saitama, Japan

TEL

049-295-1001

Email

maruya@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kohei Maruya

Organization

Saitama medical university

Division name

Department of physical therapy, Faculty of health and medical care

Zip code


Address

981, Kawakado, Moroyama-town, Iruma-gun, Saitama, Japan

TEL

049-295-1001

Homepage URL


Email

maruya@saitama-med.ac.jp


Sponsor or person

Institute

Saitama medical university

Institute

Department

Personal name



Funding Source

Organization

Saitama medical university

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 01 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

2017 Year 07 Month 31 Day

Date of IRB

2017 Year 07 Month 31 Day

Anticipated trial start date

2017 Year 08 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information

none


Management information

Registered date

2017 Year 07 Month 03 Day

Last modified on

2020 Year 05 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032123


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name