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

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 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

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

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
Registered date File name

Research case data
Registered date File name