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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000047789 |
Receipt No. | R000054483 |
Scientific Title | Wearable device-enhanced Interactive cardiac rehabilitation program Construction and implementation of "Remote Cardiac Rehabilitation with Fitbit Sense Project to Maximize Prevention of Recurrence of Cardiovascular Disease |
Date of disclosure of the study information | 2022/05/18 |
Last modified on | 2022/05/18 |
Basic information | ||
Public title | Wearable device-enhanced Interactive cardiac rehabilitation program
Construction and implementation of "Remote Cardiac Rehabilitation with Fitbit Sense Project to Maximize Prevention of Recurrence of Cardiovascular Disease |
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Acronym | Wearable device-enhanced Interactive cardiac rehabilitation program
Construction and implementation of "Remote Cardiac Rehabilitation with Fitbit Sense Project to Maximize Prevention of Recurrence of Cardiovascular Disease |
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Scientific Title | Wearable device-enhanced Interactive cardiac rehabilitation program
Construction and implementation of "Remote Cardiac Rehabilitation with Fitbit Sense Project to Maximize Prevention of Recurrence of Cardiovascular Disease |
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Scientific Title:Acronym | Wearable device-enhanced Interactive cardiac rehabilitation program
Construction and implementation of "Remote Cardiac Rehabilitation with Fitbit Sense Project to Maximize Prevention of Recurrence of Cardiovascular Disease |
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Region |
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Condition | ||
Condition | Patients who have undergone drug therapy, coronary stenting, or coronary artery bypass surgery for coronary artery disease | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare changes in aerobic exercise capacity and exercise tolerance in cardiopulmonary exercise stress test for coronary artery disease patients in the maintenance phase of cardiac rehabilitation 3 months after intervention in the wearable device group and the wearable device + online instruction from a healthcare provider group. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Changes in aerobic capacity and exercise tolerance over 3 month |
Key secondary outcomes | Cardiac rehabilitation rates, frequency and burden of digital device use, changes in coronary artery disease risk (blood pressure levels, lipid profile, diabetes biomarkers, smoking habits), and changes in patient attitudes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Wearable device worn + online instruction for 3 months | |
Interventions/Control_2 | Wearable device worn for 3 months | |
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) Patients indicated for outpatient cardiac rehabilitation in secondary prevention of coronary artery disease
(2) Patients who are 20 years of age or older at the time of obtaining consent. (3) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study. |
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Key exclusion criteria | (1) Users of implantable medical devices such as cardiac pacemakers and defibrillators
(2) Patients diagnosed with acute myocardial infarction, unstable angina pectoris not stabilized by medical treatment, uncontrolled arrhythmia causing subjective symptoms or hemodynamic abnormalities, uncontrolled heart failure, symptomatic severe aortic stenosis, or psychiatric disorder that prevents communication (3) Patients who are judged to be inappropriate for this study by the principal investigator and the research physician. |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Juntendo University School of Medicine | ||||||
Division name | Department of Cardiovascular Biology and Medicine | ||||||
Zip code | 113-8421 | ||||||
Address | 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan | ||||||
TEL | 03-3813-3111 | ||||||
tdohi@juntendo.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Juntendo University School of Medicine | ||||||
Division name | Department of Cardiovascular Biology and Medicine | ||||||
Zip code | 113-8421 | ||||||
Address | 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan | ||||||
TEL | 03-3813-3111 | ||||||
Homepage URL | |||||||
r-nishio@juntendo.ac.jp |
Sponsor | |
Institute | Department of Cardiovascular Biology and Medicine, Juntendo University School of Medicine, Tokyo, Japan |
Institute | |
Department |
Funding Source | |
Organization | M3, Inc. |
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 | Juntendo University |
Address | 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan |
Tel | 03-3813-3111 |
kenkyu5858@juntendo.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 | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054483 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |