Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR

NCT ID: NCT04166682

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-09

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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Conditions

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Aortic Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group

Routine care

Group Type PLACEBO_COMPARATOR

Routine care

Intervention Type BEHAVIORAL

Routine care and followup

Interventional Group

Home-based cardiac rehabilitation

Group Type EXPERIMENTAL

Home-based cardiac rehabilitation

Intervention Type BEHAVIORAL

cardiac rehabilitation done at home

Interventions

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Home-based cardiac rehabilitation

cardiac rehabilitation done at home

Intervention Type BEHAVIORAL

Routine care

Routine care and followup

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xianbao Liu, Doctor

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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The second affiliated hospital of zhejiang university, school of medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoya Wang, Doctor

Role: CONTACT

+86-15715702712

Facility Contacts

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Xiaoya Wang, Doctor

Role: primary

15715702712

References

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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.

Reference Type DERIVED
PMID: 33962483 (View on PubMed)

Other Identifiers

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ZJUWXY

Identifier Type: -

Identifier Source: org_study_id

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