UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046278
Receipt number R000042377
Scientific Title The population-based prospective cohot study in Tarumizu city
Date of disclosure of the study information 2021/12/10
Last modified on 2023/06/12 19:47:14

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Basic information

Public title

The population-based prospective cohot study in Tarumizu city

Acronym

Tarumizu study

Scientific Title

The population-based prospective cohot study in Tarumizu city

Scientific Title:Acronym

Tarumizu study

Region

Japan


Condition

Condition

adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify how life-style, physical condition or cognitive function with aging are related to survival and functional prognosis

Basic objectives2

Others

Basic objectives -Others

To explore the following :
1. How does life-style and physical condition with aging relate to survival and functional prognosis
2. How exercise, nutrition and medical treatment can be involved in maintaining the life function of the elderly
3. Does maintaining the function of life have a positive impact on urban functions even as older?

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Mortality rate of all death and due to cardiovascular disease, cancer and pneumonia
2. Incidence of stroke, ischemic heart disease, heart failure, pneumonia, cancer, fracture and fall
3. Functional prognosis evaluated by CGA change, amount of care insurance, degree of care insurance, medical expenses

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

General population over 40 years old living in Tarumizu city

Key exclusion criteria

Not applicable.

Target sample size

2500


Research contact person

Name of lead principal investigator

1st name Mitsuru
Middle name
Last name Ohishi

Organization

Graduate school of medical and dental sciences, Kagoshima university

Division name

Cardiovascular medicine and hypertension

Zip code

890-8520

Address

8-35-1, Sakuragaoka, Kagoshima

TEL

0992755318

Email

ohishi@m2.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name Takuro
Middle name
Last name Kubozono

Organization

Graduate school of medical and dental sciences, Kagoshima university

Division name

Cardiovascular medicine and hypertension

Zip code

8900031

Address

8-35-1, Sakuragaoka, Kagoshima

TEL

0992755318

Homepage URL


Email

kubozono@m.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular medicine and hypertension, Graduate school of medical and dental sciences, Kagoshima university

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiovascular medicine and hypertension, Graduate school of medical and dental sciences, Kagoshima 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

The institutional ethics committees of the Graduate School of Medical and Dental Sciences, Kagoshima University

Address

8-35-1, Sakuragaoka, Kagoshima, Japan

Tel

0992756090

Email

isgskkrs@kuas.kagoshima-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 12 Month 10 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Open public recruiting

Date of protocol fixation

2018 Year 04 Month 01 Day

Date of IRB

2018 Year 06 Month 26 Day

Anticipated trial start date

2018 Year 06 Month 30 Day

Last follow-up date

2035 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective observational cohort study


Management information

Registered date

2021 Year 12 Month 04 Day

Last modified on

2023 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042377


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name