UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041635 |
|---|---|
| Receipt number | 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 17:11:29 |
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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
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
kyamatsu@cc.saga-u.ac.jp
Sponsor or person
Institute
Ministry of Economy, Trade and Industry, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047477
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
