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
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
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
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
