UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041746 |
|---|---|
| Receipt number | 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 | 2022/11/10 20:37:23 |
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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
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
yoshitatsu.f@gmail.com
Sponsor or person
Institute
ASAHI UNIVERSITY HOSPITAL
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046564
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
