UMIN-CTR Clinical Trial

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