UMIN-CTR Clinical Trial

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
Institute	The Institute of Medical Science, the University of Tokyo
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040444