UMIN-CTR Clinical Trial

Basic information
Public title	Development of remote program for cardiac rehabilitation using wearable electrocardiograph
Acronym	Development of remote program for cardiac rehabilitation using wearable electrocardiograph
Scientific Title	Development of remote program for cardiac rehabilitation using wearable electrocardiograph
Scientific Title:Acronym	Development of remote program for cardiac rehabilitation using wearable electrocardiograph
Region	Japan

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

Objectives
Narrative objectives1	Examination of a method for providing and constructing cardiac rehabilitation using cloud-type wearable ECG
Basic objectives2	Others
Basic objectives -Others	Home exercise therapy
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Cloud type wearable ECG, Cardiopulmonary Exercise Testing, muscle strength
Key secondary outcomes	Cardiac function, blood pressure, WHO DAS

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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	After performing supervised exercise therapy 2 times a week, various tests such as cardiopulmonary exercise test are performed, remote cardiac rehabilitation is performed 2 times a week, and supervised exercise therapy is performed.
Interventions/Control_2	After performing supervised exercise therapy 2 times a week, various tests such as cardiopulmonary exercise test are performed, and only supervised exercise therapy is performed 2 times a week.
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	Healthy subjects and patients with convalescent and stable cardiovascular disease, and patients provided signed informed consent to participate in the study
Key exclusion criteria	Patients with unstable cardiovascular disease
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yoshitatsu Middle name Last name Fukuta
Organization	Asahi University Hospital
Division name	Department of Rehabilitation
Zip code	500-8523
Address	3-23 Hashimoto,Gifu,
TEL	058-253-8734
Email	yoshitatsu.f@gmail.com

Public contact
Name of contact person	1st name Yoshitatsu Middle name Last name Fukuta
Organization	ASAHI UNIVERSITY HOSPITAL
Division name	Department of Rehabilitation
Zip code	500-8523
Address	3-23 Hashimoto,Gifu,
TEL	058-253-8734
Homepage URL
Email	yoshitatsu.f@gmail.com

Sponsor
Institute	ASAHI UNIVERSITY HOSPITAL
Institute
Department

Funding Source
Organization	ASAHI UNIVERSITY HOSPITAL SAN-EI Medicis Co., Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	ASAHI UNIVERSITY HOSPITAL
Address	3-23 Hashimoto,Gifu,
Tel	058-253-8734
Email	yoshitatsu.f@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	2020 Year 09 Month 09 Day

Related information
URL releasing protocol	prospective cohort study
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	2020 Year 07 Month 01 Day
Date of IRB	2020 Year 09 Month 09 Day
Anticipated trial start date	2020 Year 09 Month 09 Day
Last follow-up date	2022 Year 08 Month 29 Day
Date of closure to data entry	2022 Year 08 Month 29 Day
Date trial data considered complete	2022 Year 08 Month 29 Day
Date analysis concluded	2022 Year 08 Month 30 Day

Other
Other related information

Management information
Registered date	2020 Year 09 Month 09 Day
Last modified on	2022 Year 11 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046564