UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038982
Receipt No. R000024574
Scientific Title Study on the compatibility and validity for the estimation in amount of physical activity and energy expenditure.
Date of disclosure of the study information 2019/12/31
Last modified on 2019/12/25 (Ver. 1)

* 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 Study on the compatibility and validity for the estimation in amount of physical activity and energy expenditure.
Acronym Physical activity estimation study
Scientific Title Study on the compatibility and validity for the estimation in amount of physical activity and energy expenditure.
Scientific Title:Acronym Physical activity estimation study
Region
Japan

Condition
Condition None
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study was to clarify the validity and compatibility of measuring physical activity and energy expenditure using by wearable devices and questionnaires.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes physical activity, energy expenditure
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
50 years-old >=
Gender Male and Female
Key inclusion criteria Participants were nineteen healthy adults who were not obese and had no problems in daily activities.
Key exclusion criteria BMI<18.5, >=25
Patients suffering from severe diseases such as myocardial infarction and cancer
Target sample size 18

Research contact person
Name of lead principal investigator
1st name Motohiko
Middle name
Last name Miyachi
Organization National Institute of Health and Nutrition, NIBIOHN
Division name Department of Health Promotion and Exercise
Zip code 162-9636
Address 1-23-1 Toyama, Shinjuku, Tokyo, Japan
TEL 03-3203-8061
Email miyachi@nih.go.jp

Public contact
Name of contact person
1st name Motohiko
Middle name
Last name Miyachi
Organization National Institute of Health and Nutrition, NIBIOHN
Division name Department of Health Promotion and Exercise
Zip code 162-8636
Address 1-23-1 Toyama, Shinjuku, Tokyo, Japan
TEL 03-3203-8061
Homepage URL
Email miyachi@nih.go.jp

Sponsor
Institute National Institute of Health and Nutrition, NIBIOHN
Institute
Department

Funding Source
Organization AMED
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 National Institutes of Biomedical Innovation, Health and Nutrition
Address Department of Physical Activity Research
Tel 072-641-9811
Email irb-office@nibiohn.go.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
2019 Year 12 Month 31 Day

Related information
URL releasing protocol https://mhealth.jmir.org/2019/8/e13938/
Publication of results Published

Result
URL related to results and publications https://mhealth.jmir.org/2019/8/e13938/
Number of participants that the trial has enrolled 19
Results 
Although wearable devices for estimating energy expenditure are becoming increasingly popular, there is little evidence regarding their validity. 
The wearable devices that we tested were able to rank daily total energy expenditure between individuals, but absolute values differed widely among devices and varied significantly from the gold standard measures. 
Furthermore, all wearable devices underestimated total energy expenditure under free-living conditions.
Results date posted
2019 Year 12 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2016 Year 05 Month 01 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 02 Month 01 Day
Date of IRB
2016 Year 08 Month 04 Day
Anticipated trial start date
2015 Year 02 Month 10 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information The research results are published as follows.
In the future more than one paper will be made public.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2500062
https://www.ncbi.nlm.nih.gov/pubmed/26999758
https://www.ncbi.nlm.nih.gov/pubmed/27598760
https://www.ncbi.nlm.nih.gov/pubmed/29709888
https://www.ncbi.nlm.nih.gov/pubmed/31376273

Management information
Registered date
2019 Year 12 Month 25 Day
Last modified on
2019 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024574