UMIN-CTR Clinical Trial

Basic information
Public title	Study on safe rehabilitation after heart disease using a wearable device with bone conduction speaker whose pulse rate and oxygen saturation can be measured (the second stage)
Acronym	A study on safe cardiac rehabilitation using a wearable device (second stage)
Scientific Title	Examination of feasibility regarding safe enforcement of cardiac rehabilitation using a wearable device equipped with a bone conduction speaker capable of biological information monitoring (phase 2)
Scientific Title:Acronym	Demonstration experiment to safely perform cardiac rehabilitation using wearable devices (phase 2)
Region	Japan

Condition
Condition	Acute myocardial infarction, heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Feasibility study about safe cardiac rehabilitation using wearable device with bone conduction speaker that can monitor biological information for hospitalized patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Record biological information such as pulse, oxygen saturation and temperature. Safe cardiac rehabilitation without any complications.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Wear headphones with bone conduction speakers that can measure pulse and oxygen saturation.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Men and women aged 20 and over at the time of consent acquisition. 2) Patients who obtained written consent by their own free will after sufficient explanation after participation in this study
Key exclusion criteria	Patients who the research director and the assigned researcher judged inappropriate as the research subject
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tetsuo Middle name Last name Sasano
Organization	Tokyo Medical and Dental University
Division name	Cardiovascular Medicine
Zip code	113-8510
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo-to
TEL	03-5803-5205
Email	sasano.cvm@tmd.ac.jp

Public contact
Name of contact person	1st name Tomoyuki Middle name Last name Umemoto
Organization	Tokyo Medical and Dental University
Division name	Cardiovascular Medicine
Zip code	113-8510
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo-to
TEL	03-5803-5231
Homepage URL
Email	umemoto.cvm@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	KYOCERA corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo-to
Tel	03-3813-6111
Email	info.bec@tmd.ac.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 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	Preinitiation
Date of protocol fixation	2019 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 02 Day
Last modified on	2019 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042851

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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