UMIN-CTR Clinical Trial

Basic information
Public title	Development and a Randomized Open-Label Controlled Trial of Remote Cardiac Rehabilitation with Wearable Medical Devices
Acronym	TELE cardiac REHAbilitation system using tele-nursing with apple watch-a large prospective randomized study
Scientific Title	TELE cardiac REHAbilitation system using tele-nursing with apple watch-a large prospective randomized study
Scientific Title:Acronym	TELE-REHA Trial
Region	Japan

Condition
Condition	Cardiovascular diseases
Classification by specialty	Cardiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	All death, cardiovascular events
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	All death, cardiovascular events
Key secondary outcomes	EFs, e/e', BNP, CRP, PeakVO2, VE-VCO2 slop, muscular mass,EQ5D,ICER

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	remote-cardiac rehabilitation
Interventions/Control_2	outpatient-cardiac rehabilitation
Interventions/Control_3	non-cardiac rehabilitation
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	18 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who were discharged home after undergoing cardiac surgery or treatment with cardiac catheterization.
Key exclusion criteria	1) AMI 2) UAP 3) Pregnancy or nursing 4) uncontrolled arrhythmia 5) uncontrolled AS 6) uncontrolled heart failure 7) acute pulmonary thromboembolism 8) acute myocarditis 9) acute aortic dissection 10) difficulty walking 11) lack of mental capacity 12) pacemaker, implantable cardioverter-defibrillator 13) Others
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Atsuko Middle name Last name Nakayama
Organization	Sakakibara Heart Institute
Division name	Cardiac Rehabilitation Department
Zip code	1830003
Address	Asahi-Chou, Fuchu-City
TEL	+81423143111
Email	atsukonakanaka@gmail.com

Public contact
Name of contact person	1st name Atsuko Middle name Last name Nakayama
Organization	The University of Tokyo Hospital
Division name	Cardiac Rehabilitation Department
Zip code	1830003
Address	Asahi-Chou, Fuchu-City
TEL	+81423143111
Homepage URL
Email	atsukonakanaka@gmail.com

Sponsor
Institute	Sakakibara Heart Institute
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development(AMED)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Sakakibara Heart Institute
Address	3-16-1, Asahi-Chou, Fuchu-City
Tel	+81423143111
Email	atsukonakanaka@gmail.com

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 08 Month 10 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	Preinitiation
Date of protocol fixation	2021 Year 06 Month 04 Day
Date of IRB	2021 Year 07 Month 29 Day
Anticipated trial start date	2021 Year 08 Month 15 Day
Last follow-up date	2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 31 Day
Last modified on	2021 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051428