UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035474
Receipt No. 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 2019/01/14

* 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
Last 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
Email iwabu-tky@umin.ac.jp

Public contact
1st 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
Email iwabu-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2018 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
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 01 Month 14 Day


Link to view the page
URL(English) https://upload.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


Contact us.