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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041635
Receipt No. R000047477
Scientific Title The effectiveness of remote exercise intervention using IoT: Randomized controlled trial
Date of disclosure of the study information 2020/09/01
Last modified on 2020/09/01

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Basic information
Public title Development and evaluation of remote exercise intervention using IoT
Acronym Development and evaluation of remote exercise intervention using IoT
Scientific Title The effectiveness of remote exercise intervention using IoT: Randomized controlled trial
Scientific Title:Acronym The effectiveness of remote exercise intervention using IoT: Randomized controlled trial
Region
Japan

Condition
Condition Care prevention
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Whether the primary outcome is physical activity such as physical activity index and the secondary outcomes are physical strength indexes such as muscle strength and walking speed, and the non-face-to-face program that continuously provides these outcomes enhanced by the face-to-face exercise guidance can be maintained by the physical outcome. The purpose of this research is to investigate whether it affects the maintenance of activity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical activity and sitting time using wearable devices during 15 weeks
Key secondary outcomes Body weight, body composition, physical fitness index (pre-intervention, 7 weeks, 15 weeks)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 four behavior change coaching interviews group
Interventions/Control_2 three behavior change coaching interviews group
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
50 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria Residents in the fifties and sixties of Yukuhashi city, Fukuoka own a smartphone or tablet device that can communicate.
Key exclusion criteria Persons with illness or illness being treated. And person who does not have environment to access the Internet with smartphone or tablet PC
Target sample size 30

Research contact person
Name of lead principal investigator
1st name KOJI
Middle name
Last name YAMATSU
Organization Saga University
Division name Faculty of Education
Zip code 840-8502
Address 1 Honjyo-machi, Saga-city, Japan
TEL 0952288302
Email kyamatsu@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name KOJI
Middle name
Last name YAMATSU
Organization Saga University
Division name Faculty of Education
Zip code 840-8502
Address 1 Honjyo-machi, Saga-city, Japan
TEL 0952288302
Homepage URL
Email kyamatsu@cc.saga-u.ac.jp

Sponsor
Institute Ministry of Economy, Trade and Industry, Japan
Institute
Department

Funding Source
Organization Ministry of Economy, Trade and Industry, Japan
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 Saga University
Address 1 Honjyo-machi, Saga-city, Japan
Tel 0952288302
Email kyamatsu@cc.saga-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
2020 Year 09 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 30
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
2019 Year 10 Month 09 Day
Date of IRB
2019 Year 10 Month 09 Day
Anticipated trial start date
2019 Year 10 Month 09 Day
Last follow-up date
2020 Year 02 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 01 Day
Last modified on
2020 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047477

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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