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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033349
Receipt No. R000038018
Scientific Title IoT-Based Intervention for Changing Exercsie Behavior: Prevention of Frailty
Date of disclosure of the study information 2018/08/01
Last modified on 2019/01/15

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Basic information
Public title IoT-Based Intervention for Changing Exercsie Behavior: Prevention of Frailty
Acronym IoT-Based Exercise Intervention Trial
Scientific Title IoT-Based Intervention for Changing Exercsie Behavior: Prevention of Frailty
Scientific Title:Acronym IoT-Based Exercise Intervention Trial
Region
Japan

Condition
Condition frailty prevention
Classification by specialty
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of IoT-based exercisse intervention on frailty prevention
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of several fitness measures for three months
Key secondary outcomes Transition rate from pre-frailty to non-fraility for three months

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 IoT-based exercise intervention with behavioral counseling
Interventions/Control_2 IoT-based exercise intervention without behavioral counseling
Interventions/Control_3 face-to-face based exercise intervention with behavioral counseling
Interventions/Control_4 face-to-face based exercise intervention without behavioral counseling
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
75 years-old >
Gender Male and Female
Key inclusion criteria pre-frailty or frailty
Key exclusion criteria care-need certificated person and/or person forbided from exercising by the doctor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuzo Kumagai
Organization Kyushu University
Division name Counseling and Health Center
Zip code
Address 6-1 Kasuga-koen, Kasuga-city, Fukuoka, Japan
TEL 092-583-7853
Email shuzo@ihs.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rie Kuriya
Organization Kyushu University
Division name Counseling and Health Center
Zip code
Address 6-1 Kasuga-koen, Kasuga-city, Fukuoka, Japan
TEL 092-583-7853
Homepage URL https://iot-frail.org/
Email AMED2018@ihs.kyushu-u.ac.jp

Sponsor
Institute Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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
2018 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
2018 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 15 Day
Last follow-up date
2018 Year 12 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 10 Day
Last modified on
2019 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038018

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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