UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048412 |
|---|---|
| Receipt number | R000054948 |
| Scientific Title | Effectiveness of remote cardiac rehabilitation after transcatheter aortic valve implantation |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/07/20 10:43:39 |
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Basic information
Public title
Effectiveness of remote cardiac rehabilitation after transcatheter aortic valve implantation
Acronym
Effectiveness of remote cardiac rehabilitation after TAVI
Scientific Title
Effectiveness of remote cardiac rehabilitation after transcatheter aortic valve implantation
Scientific Title:Acronym
Effectiveness of remote cardiac rehabilitation after TAVI
Region
| Japan |
Condition
Condition
Severe aortic valve stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the effectiveness of remote cardiac rehabilitation after transcatheter aortic valve implantation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of 6 minutes walking distance before and after remote cardiac rehabilitation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
remote 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
Any patients who undergo transcatheter valve implantation satisfying following conditions
- 20years old over
- patients who can not undergo cardiac rehabilitation in the hospital
Key exclusion criteria
-no internet environment
-exercise therapy is contraindicated
-unable to row motorcycle
-unable to operate app due to visual and hearing impairment
-planed in-patient rehabilitation for more than 4weeks
Patients with acute myocardial infarction with significant (>75%) untreated coronary stenosis in the major three branches
- Patients who have been exercising regularly (at least once a week) within the last 6 weeks of obtaining consent
- Patients with end-stage heart failure
- Patients with evidence of residual myocardial ischemia
- Patients with poorly controlled heart failure
- Patients after implantation of a left ventricular assist device
- Patients with an expected prognosis of 6 months or less
- Patients who have participated in other clinical trials or clinical studies involving interventions within the past 12 weeks of obtaining consent
- Patients who are judged by the investigators to be incapable of correctly understanding the significance of the research and complying with the compliance requirements due to dementia, psychiatric disorders, etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Nakmaura |
Organization
Osaka university graduate school of medicine
Division name
Department of cardiovascular medicine
Zip code
5650871
Address
2-15 Yamadaoka, Suita city
TEL
0668793640
nakamura@cardiology.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Nakamura |
Organization
Osaka university graduate school of medicine
Division name
Department of cardiovascular medicine
Zip code
5650871
Address
2-15 Yamadaoka, Suita city
TEL
09022347714
Homepage URL
nakamura@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Osaka university graduate school of medicine
Address
2-15 Yamadaoka, Suita city
Tel
09022347714
nakamura@cardiology.med.osaka-u.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
| 2022 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2022 | Year | 07 | Month | 20 | Day |
Last modified on
| 2022 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054948
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
