UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035495
Receipt number R000040444
Scientific Title The efficacy of intervention by physical exercise in the people living in isolated islands to prevent emergency transports.
Date of disclosure of the study information 2019/01/09
Last modified on 2021/02/15 17:28:23

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Basic information

Public title

The efficacy of intervention by physical exercise in the people living in isolated islands to prevent emergency transports.

Acronym

The efficacy of intervention by physical exercise in the people living in isolated islands to prevent emergency transports.

Scientific Title

The efficacy of intervention by physical exercise in the people living in isolated islands to prevent emergency transports.

Scientific Title:Acronym

The efficacy of intervention by physical exercise in the people living in isolated islands to prevent emergency transports.

Region

Japan


Condition

Condition

chronic illness, osteoporosis, and patients with potentially high risk for emergency admissions.

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To validate the efficacy of intervention by physical exercise in the people living in isolated islands to prevent emergency transports outside islands.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) Emergency transport to outside the island by any reason

Key secondary outcomes

1) Emergency transport to outside the island by fractures
2) Medical costs per resident
3) 7 ADLs score
4) SF-12 score
5) IPAQ score


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Provide exercise class at a nearest community center once a week.

Interventions/Control_2

No additional intervention.

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

1) Residents in Koshikijima
2) Consent to participate in the study "Establishment of the surveillance system exploring risk factors for emergency transportation outside a remote island"
3) Aged 40 years old or older
4) Informed consent

Key exclusion criteria

Not applicable

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Shimada

Organization

Research Hospital, The Institute of Medical Science, the University of Tokyo

Division name

Department of Palliative Medicine

Zip code


Address

4-6-1 Shirokanedai, Minato-ku, Tokyo, 108-8639, Japan

TEL

03-3443-8111

Email

nshimada@ims.u-tokyo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoki Shimada

Organization

Research Hospital, The Institute of Medical Science, the University of Tokyo

Division name

Department of Palliative Medicine

Zip code


Address

4-6-1 Shirokanedai, Minato-ku, Tokyo, 108-0071, Japan

TEL

03-3443-8111

Homepage URL


Email

nshimada@ims.u-tokyo.ac.jp


Sponsor or person

Institute

The Institute of Medical Science, the University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Ministry of Internal Affairs and Communications

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


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

2019 Year 01 Month 09 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 27 Day

Date of IRB

2017 Year 06 Month 22 Day

Anticipated trial start date

2017 Year 09 Month 18 Day

Last follow-up date

2018 Year 07 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

2019 Year 01 Month 09 Day

Last modified on

2021 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040444


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name