UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042942 |
|---|---|
| Receipt number | R000048983 |
| Scientific Title | A multicenter study about the efficacy of remote technology in cardiac rehabilitation |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2021/07/08 23:30:25 |
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Basic information
Public title
A multicenter study about the efficacy of remote technology in cardiac rehabilitation
Acronym
Remote technology in cardiac rehabilitation
Scientific Title
A multicenter study about the efficacy of remote technology in cardiac rehabilitation
Scientific Title:Acronym
Remote technology in cardiac rehabilitation
Region
| Japan | Asia(except Japan) |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Medicine in general | Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation about the safety and efficacy of remote technology in cardiac rehabilitation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of the level of peak VO2 or the distance of 6 minutes walk test
Key secondary outcomes
Parameters about cardiopulmonary exercise test / event rate (all-cause death, cardiac death, cardiac admission) / the level of BNP or NT-pro BNP, QOL score, physical activity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
System of remote technology in cardiac rehabilitation
Interventions/Control_2
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
1) patients who is admitted due to cardiovascular disorders for cardiac rehabilitation (IHD, heart failure, aortic disease, post cardiac surgery, peripheral artery disease)
2) CPX or 6 minutes walk can be performed with 2-3 months interval
Key exclusion criteria
1) lower than 20 year old
2) patients who are considered to be inappropriate for the study
3) high risk for exercise training (severe AS, NYHA IV, ventricular arrhythmia, severe renal or liver dysfunction
4) post ICD or CRTD or LVAD
5) low cognitive function
6) end stage of heart failure
7) pregnant
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | Tokyo |
| Last name | Amiya |
Organization
the University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
1138655
Address
Bunkyo-ku Hongo
TEL
0338155411
amiyae-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Itoh |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
1130033
Address
Bunkyo-ku Hongo
TEL
0338155411
Homepage URL
hitoh.ggl@gmail.com
Sponsor or person
Institute
Tokyo university
Institute
Department
Personal name
Funding Source
Organization
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
Tokyo university
Address
Bunkyo-ku Hongo
Tel
03-3815-5411
amiyae-tky@umin.ac.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
| 2021 | Year | 02 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 01 | Month | 07 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048983
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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