UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047789 |
|---|---|
| Receipt number | 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 | 2024/05/27 14:35:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
Region
| Japan |
Condition
Condition
Patients who have undergone drug therapy, coronary stenting, or coronary artery bypass surgery for coronary artery disease
Classification by specialty
| Cardiology |
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
| Behavior,custom |
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
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.
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.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomotaka |
| Middle name | |
| Last name | Dohi |
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
| 1st name | Ryota |
| Middle name | |
| Last name | Nishio |
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 or person
Institute
Department of Cardiovascular Biology and Medicine, Juntendo University School of Medicine, Tokyo, Japan
Institute
Department
Personal name
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
| 2022 | Year | 05 | Month | 18 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 11 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 18 | Day |
Last modified on
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054483
