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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034967
Receipt No. R000039870
Official scientific title of the study 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

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Basic information
Official scientific title of the study Feasibility study of wearable sensor in the measurement of exercise intensity
Title of the study (Brief title) 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 Masahiko Mukaino
Organization Fujita Health University
Division name Department of rehabilitation medicine I
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-2167
Email mmukaino@fujita-hu.ac.jp

Public contact
Name of contact person Masahiko Mukaino
Organization Fujita Health University
Division name Department of rehabilitation medicine I
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-2167
Homepage URL
Email mmukaino@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039870

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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