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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046102
Receipt No. R000052628
Scientific Title Construction and implementation of a cardiac rehabilitation program "Cardiac Rehabilitation with amue link" using amue link: Project for maximizing prevention of recurrence of cardiovascular diseases
Date of disclosure of the study information 2021/11/17
Last modified on 2021/11/17

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Basic information
Public title Construction and implementation of a cardiac rehabilitation program "Cardiac Rehabilitation with amue link" using amue link: Project for maximizing prevention of recurrence of cardiovascular diseases
Acronym Construction and implementation of a cardiac rehabilitation program "Cardiac Rehabilitation with amue link" using amue link: Project for maximizing prevention of recurrence of cardiovascular diseases
Scientific Title Construction and implementation of a cardiac rehabilitation program "Cardiac Rehabilitation with amue link" using amue link: Project for maximizing prevention of recurrence of cardiovascular diseases
Scientific Title:Acronym Construction and implementation of a cardiac rehabilitation program "Cardiac Rehabilitation with amue link" using amue link: Project for maximizing prevention of recurrence of cardiovascular diseases
Region
Japan

Condition
Condition Coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 As a preliminary test to verify whether the use of the digital device "amue link" can improve the rate of cardiac rehabilitation and motivate the patients to practice the exercise program, we will actually provide the amue link to the target patients and confirm the rate of cardiac rehabilitation in the patients. In addition, changes in exercise tolerance, atherosclerosis risk (hypertension, dyslipidemia, diabetes, and smoking history), and changes in patients' consciousness will also be confirmed.
Basic objectives2 Others
Basic objectives -Others usefulness
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Cardiac rehabilitation implementation rate
Key secondary outcomes Frequency and burden of digital device use, degree of change in exercise tolerance, change in atherosclerosis risk (hypertension, dyslipidemia, diabetes, smoking history), and change in patient awareness

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
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) Age 20 years or older at the time of obtaining consent
(3) Patients who have received sufficient explanation for participation in this study, and have given their free written consent with full understanding
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 disorders that prevent communication
(3) Patients who are judged by the principal investigator and sub-investigator to be inappropriate for this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Tomotaka
Middle name
Last name Dohi
Organization Juntendo University School of Medicine, Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 113-8421
Address 2-1-1 Hongo, Bukyo-ku, Tokyo
TEL 03-3813-3111
Email tdohi@juntendo.ac.jp

Public contact
Name of contact person
1st name Tomotaka
Middle name
Last name Dohi
Organization Juntendo University School of Medicine, Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 113-8421
Address 2-1-1 Hongo, Bukyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email tdohi@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization (None)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University Hospital Department of Medicine Research Ethics Committee
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-8431
Tel 03-3813-3111
Email N@A

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
2021 Year 11 Month 17 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
2021 Year 07 Month 29 Day
Date of IRB
2021 Year 08 Month 27 Day
Anticipated trial start date
2021 Year 09 Month 03 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2021 Year 11 Month 17 Day
Last modified on
2021 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052628

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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