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

May 9, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Study of the Impact of Home-based Cardiac Rehabilitation on Outcomes After Transcatheter Aortic Valve Replacement (TAVR)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University, School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Routine care
Behavioral: Routine care
Routine care and followup
Experimental: Interventional Group
Home-based cardiac rehabilitation
Behavioral: Home-based cardiac rehabilitation
cardiac rehabilitation done at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute walk test
Time Frame: 6 weeks
The total distance walked in meters during 6 minutes.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants die
Time Frame: 6 weeks, 12 months
Number of participants die during the study due to cardiovascular or non-cardiovascular causes.
6 weeks, 12 months
Number of participants rehospitalized
Time Frame: 6 weeks, 12 months
Number of participants rehospitalized during the study.
6 weeks, 12 months
Number of participants completing home-based cardiac rehabilitation
Time Frame: 6 weeks
Number of participants completing home-based cardiac rehabilitation
6 weeks
Cardiac function
Time Frame: 12 months
Ejection fraction estimated by echocardiography
12 months
Aortic valve function
Time Frame: 12 months
Aortic valve function estimated by echocardiography
12 months
Number of participants injured
Time Frame: 6 weeks
Number of participants injured or die during the course of home-based cardiac rehabilitation
6 weeks
Time spent performing activities
Time Frame: 6 weeks, 12 months
Number of minutes in a typical week that participants spent performing activities
6 weeks, 12 months
6-minute walk test
Time Frame: 12 months
The total distance walked in meters during 6 minutes
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Xianbao Liu, Doctor, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 9, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJUWXY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortic Stenosis

Clinical Trials on Routine care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe