UMIN-CTR Clinical Trial

Basic information
Public title	Home-based real-time cardiac telerehabilitation: a randomized controlled non-inferiority trial
Acronym	Home-based real-time cardiac telerehabilitation: a randomized controlled non-inferiority trial
Scientific Title	Home-based real-time cardiac telerehabilitation: a randomized controlled non-inferiority trial
Scientific Title:Acronym	Home-based real-time cardiac telerehabilitation: a randomized controlled non-inferiority trial
Region	Japan

Condition
Condition	heart disease
Classification by specialty	Cardiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the safety and efficacy of home-based real-time remotely monitored cardiac telerehabilitation with center-based outpatient cardiac rehabilitation program among patients with cardiovascular disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	peak oxygen uptake
Key secondary outcomes	cardiac event duding exercise and fall

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	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Supervised exercise training twice weekly for 4-week at the hospital and supervised real-time tele rehabilitation twice weekly 8-week at home.
Interventions/Control_2	Patients continue supervised exercise training twice weekly for 12-week at hospital.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients provided signed informed consent to participate in the study, and have internet access at home
Key exclusion criteria	Patients with absolute contraindications to cardiac rehabilitation, could not exercise using cycle ergometer caused by severe functional decline or disability
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masakazu Middle name Last name Saitoh
Organization	Sakakibara Heart Institute
Division name	Department of Rehabilitation
Zip code	1830003
Address	3-16-1. Asahi-cho, Fuchu, Tokyo
TEL	042-313-3111
Email	msaitoh@shi.heart.or.jp

Public contact
Name of contact person	1st name Kanae Middle name Last name Asami
Organization	Sakakibara Heart Institute
Division name	Department of clinical reserch support
Zip code	1830003
Address	3-16-1. Asahi-cho, Fuchu, Tokyo
TEL	042-313-3111
Homepage URL
Email	hij-p@shi.heart.or.jp

Sponsor
Institute	Sakakibara Heart Institute
Institute
Department

Funding Source
Organization	The Japanese Association of Cardiac Rehabilitation Japan Heart Club
Organization
Division
Category of Funding Organization	Non profit foundation
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-cho, Fuchu, Tokyo
Tel	042-314-3111
Email	hij-p@shi.heart.or.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	2020 Year 06 Month 05 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	Completed
Date of protocol fixation	2019 Year 07 Month 01 Day
Date of IRB	2019 Year 07 Month 02 Day
Anticipated trial start date	2019 Year 11 Month 01 Day
Last follow-up date	2020 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	2020 Year 06 Month 05 Day
Last modified on	2021 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046406