UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035474 |
|---|---|
| Receipt number | R000040410 |
| Scientific Title | Development of a New Algorithm for Measurement of Physical Activity Using Wearable Measuring Devices and Analysis of Its Correlation with Physiologically Active Substances |
| Date of disclosure of the study information | 2019/01/08 |
| Last modified on | 2019/04/07 13:53:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a New Algorithm for Measurement of Physical Activity Using Wearable Measuring Devices and Analysis of Its Correlation with Physiologically Active Substances
Acronym
Development of a New Algorithm for Measurement of Physical Activity Using Wearable Measuring Devices and Analysis of Its Correlation with Physiologically Active Substances
Scientific Title
Development of a New Algorithm for Measurement of Physical Activity Using Wearable Measuring Devices and Analysis of Its Correlation with Physiologically Active Substances
Scientific Title:Acronym
Development of a New Algorithm for Measurement of Physical Activity Using Wearable Measuring Devices and Analysis of Its Correlation with Physiologically Active Substances
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate, in an exploratory fashion, the relationship between amount of physical activity, obtained by using wearable measuring devices, and various physical data as well as blood test data.
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between amount of physical activity, obtained by using wearable measuring devices, and physiologically active substances
Key secondary outcomes
･ Relation between amount of physical activity, obtained by using wearable measuring devices, and physical data
･ Relation between amount of physical activity, obtained by using wearable measuring devices, and a smartphone-based record of subjective symptoms (ecological momentary assessment)
･ Relation between amount of physical activity, obtained by using wearable measuring devices, and amount of physical activity obtained by using the International Physical Activity Questionnaire (IPAQ)
･ Relation between amount of physical activity, obtained by using wearable measuring devices, and psychological characteristics and statuses as evaluated by the Beck Depression Inventory (BDI) and the State-Trait Anxiety Inventory (STAI)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Persons participating in the study will put on wearable devices after undergoing regular health checkups. They will be asked to wear them continuously while going about their daily lives for three weeks from the starting date (the main observation period). The participants may remove them temporarily if they wish. During the main observation period, moreover, they will be asked to answer questions using a smartphone. They will also fill in a written questionnaire before, during, and after the main observation period. Physical measurements and drawing of blood will be performed on the last day that the device is worn.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Plan to undergo regular health checkups
2. Men and women aged 20 - 75
3. Written informed consent to participate in the study
Key exclusion criteria
1. Instructed to minimize physical exercise because of cardiovascular or other diseases
2. Associated with severe hepatopathy, nephropathy, malignant tumor (excluding those that have not recurred for 5 years) and/or infectious diseases
3. A history of physical and/or mental disease(s)
4. Is pregnant or plans to become pregnant during the study period
Visits a hospital regularly, and is judged by the attending physician to be unfit to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Iwabu |
Organization
The University of Tokyo Hospital
Division name
Department of Diabetes and Metabolic Diseases
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-9166
iwabu-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Iwabu |
Organization
The University of Tokyo Hospital
Division name
Department of Diabetes and Metabolic Diseases
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-9166
Homepage URL
iwabu-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical and Dental University
Osaka University
Tohoku University
Uguisudani Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
鶯谷健診センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 07 | Day |
Last modified on
| 2019 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040410
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
