UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041746
Receipt No. R000046564
Scientific Title Development of remote program for cardiac rehabilitation using wearable electrocardiograph
Date of disclosure of the study information 2020/09/09
Last modified on 2020/09/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 1-2 times a week, various tests such as cardiopulmonary exercise test are performed, remote cardiac rehabilitation is performed 1-2 times a week, and supervised exercise therapy is performed.
Interventions/Control_2 After performing supervised exercise therapy 1-2 times a week, various tests such as cardiopulmonary exercise test are performed, and only supervised exercise therapy is performed 1-2 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 30

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
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 Open public recruiting
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
2024 Year 07 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 09 Month 09 Day
Last modified on
2020 Year 09 Month 11 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.