UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034967 |
|---|---|
| Receipt number | R000039870 |
| Scientific Title | Feasibility study of wearable sensor in the measurement of exercise intensity |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2018/11/21 18:28:50 |
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Basic information
Public title
Feasibility study of wearable sensor in the measurement of exercise intensity
Acronym
Feasibility study of wearable sensor in the measurement of exercise intensity
Scientific Title
Feasibility study of wearable sensor in the measurement of exercise intensity
Scientific Title:Acronym
Feasibility study of wearable sensor in the measurement of exercise intensity
Region
| Japan |
Condition
Condition
Heathy subject and stroke patients
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Percent heart rate reserve (%HRR) during exercise is commonly used as an exercise intensity index. However, fluctuation of resting heart rate (HR) in awake conditions could negate the reliability of %HRR measurement. This study examined the hypothesis that %HRR calculated using resting HR during sleep could improve accuracy of the measurement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
%HRR
Key secondary outcomes
heart rate, measurement variables obtained by accelerometer
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults without history of stroke, neurological and muscular diseases, organic diseases of the larynx / pharynx, respiratory diseases or upper gastrointestinal disease.
Patients who participated rehabilitation program in Fujita Health University who matches the following criteria.
1. Subjects those who are over 20 years old who agreed to participate to the experiment after having received sufficient explanation.
2. Subjects who is stable in body condition
Key exclusion criteria
1. Person conducting electrocardiogram monitoring due to therapeutic necessity
2. Persons who cannot understand instructions due to disturbance of consciousness or severe aphasia
3. Other persons who have judged that the participation to the experiment is inappropriate by the researchers
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Mukaino |
Organization
Fujita Health University
Division name
Department of rehabilitation medicine I
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
mmukaino@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Mukaino |
Organization
Fujita Health University
Division name
Department of rehabilitation medicine I
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
Homepage URL
mmukaino@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exercise intensity is calculated from heart rate measured by wearable monitor and compared with the exercise intensity measured by gas analysis. The amount of activity per day would be measured using the integral value of exercise intensity of the day.
Management information
Registered date
| 2018 | Year | 11 | Month | 21 | Day |
Last modified on
| 2018 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039870
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
