UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038982 |
|---|---|
| Receipt number | 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 09:48:14 |
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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
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
miyachi@nih.go.jp
Sponsor or person
Institute
National Institute of Health and Nutrition, NIBIOHN
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024574
