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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037589
Receipt No. R000042851
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)
Date of disclosure of the study information 2019/12/01
Last modified on 2019/08/02

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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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