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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048412
Receipt No. 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

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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
Email 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
Email nakamura@cardiology.med.osaka-u.ac.jp

Sponsor
Institute Osaka university graduate school of medicine
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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