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Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR (HBCR-TAVR)

Primary Purpose

Aortic Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Home-based cardiac rehabilitation
Routine care
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aortic Stenosis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aortic stenosis accepted for TAVR
  • Participant able and willing to give written informed consent
  • Participant able (in the investigator's opinion) and willing to comply with all study requirements

Exclusion Criteria: subjects may not enter the study if any of the following apply

  • Intervention deemed inappropriate due to co-morbidity or frailty
  • Life expectancy less than one year due to co-morbidity
  • Previous surgical aortic valve replacement (sAVR) or TAVR
  • Predominant aortic regurgitation

Sites / Locations

  • The second affiliated hospital of zhejiang university, school of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Interventional Group

Arm Description

Routine care

Home-based cardiac rehabilitation

Outcomes

Primary Outcome Measures

6-minute walk test
The total distance walked in meters during 6 minutes.

Secondary Outcome Measures

Number of participants die
Number of participants die during the study due to cardiovascular or non-cardiovascular causes.
Number of participants rehospitalized
Number of participants rehospitalized during the study.
Number of participants completing home-based cardiac rehabilitation
Number of participants completing home-based cardiac rehabilitation
Cardiac function
Ejection fraction estimated by echocardiography
Aortic valve function
Aortic valve function estimated by echocardiography
Number of participants injured
Number of participants injured or die during the course of home-based cardiac rehabilitation
Time spent performing activities
Number of minutes in a typical week that participants spent performing activities
6-minute walk test
The total distance walked in meters during 6 minutes

Full Information

First Posted
August 26, 2019
Last Updated
May 9, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04166682
Brief Title
Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR
Acronym
HBCR-TAVR
Official Title
A Study of the Impact of Home-based Cardiac Rehabilitation on Outcomes After Transcatheter Aortic Valve Replacement (TAVR)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the effects of a home-based cardiac rehabilitation program for Chinese patients after Transcatheter Aortic Valve Replacement (TAVR).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Routine care
Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
Home-based cardiac rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Home-based cardiac rehabilitation
Intervention Description
cardiac rehabilitation done at home
Intervention Type
Behavioral
Intervention Name(s)
Routine care
Intervention Description
Routine care and followup
Primary Outcome Measure Information:
Title
6-minute walk test
Description
The total distance walked in meters during 6 minutes.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of participants die
Description
Number of participants die during the study due to cardiovascular or non-cardiovascular causes.
Time Frame
6 weeks, 12 months
Title
Number of participants rehospitalized
Description
Number of participants rehospitalized during the study.
Time Frame
6 weeks, 12 months
Title
Number of participants completing home-based cardiac rehabilitation
Description
Number of participants completing home-based cardiac rehabilitation
Time Frame
6 weeks
Title
Cardiac function
Description
Ejection fraction estimated by echocardiography
Time Frame
12 months
Title
Aortic valve function
Description
Aortic valve function estimated by echocardiography
Time Frame
12 months
Title
Number of participants injured
Description
Number of participants injured or die during the course of home-based cardiac rehabilitation
Time Frame
6 weeks
Title
Time spent performing activities
Description
Number of minutes in a typical week that participants spent performing activities
Time Frame
6 weeks, 12 months
Title
6-minute walk test
Description
The total distance walked in meters during 6 minutes
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aortic stenosis accepted for TAVR Participant able and willing to give written informed consent Participant able (in the investigator's opinion) and willing to comply with all study requirements Exclusion Criteria: subjects may not enter the study if any of the following apply Intervention deemed inappropriate due to co-morbidity or frailty Life expectancy less than one year due to co-morbidity Previous surgical aortic valve replacement (sAVR) or TAVR Predominant aortic regurgitation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoya Wang, Doctor
Phone
+86-15715702712
Email
wxyonce@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xianbao Liu, Doctor
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
The second affiliated hospital of zhejiang university, school of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoya Wang, Doctor
Phone
15715702712
Email
wxyonce@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33962483
Citation
Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
Results Reference
derived

Learn more about this trial

Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR

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