UMIN-CTR Clinical Trial

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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