UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033349 |
|---|---|
| Receipt number | 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 | 2020/09/01 16:16:28 |
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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 | Shuzo |
| Middle name | |
| Last name | Kumagai |
Organization
Kyushu University
Division name
Counseling and Health Center
Zip code
816-8580
Address
6-1 Kasuga-koen, Kasuga-city, Fukuoka, Japan
TEL
092-583-7853
shuzo@ihs.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Kuriya |
Organization
Kyushu University
Division name
Counseling and Health Center
Zip code
816-8580
Address
6-1 Kasuga-koen, Kasuga-city, Fukuoka, Japan
TEL
092-583-7853
Homepage URL
https://iot-frail.org/
AMED2018@ihs.kyushu-u.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
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
Saga University
Address
1 Honjyo-machi, Saga-city, Japan
Tel
+81952288302
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
| 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
| 2018 | Year | 08 | Month | 13 | Day |
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
| 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=R000038018
