UMIN-CTR Clinical Trial

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