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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Acute myocardial infarction, heart failure | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | ||||||
sasano.cvm@tmd.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |