UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037589
Receipt number 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 2020/03/19 17:31:01

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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 or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



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

Enrolling by invitation

Date of protocol fixation

2019 Year 08 Month 01 Day

Date of IRB

2019 Year 10 Month 18 Day

Anticipated trial start date

2019 Year 12 Month 01 Day

Last follow-up date

2021 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

2020 Year 03 Month 19 Day



Link to view the page

Value
https://center6.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