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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

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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
Email 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
Email 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
Email 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 Open public recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 18 Day
Last modified on
2022 Year 05 Month 18 Day


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


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