Study name |
Impact of home‐based cardiac rehabilitation on outcomes after TAVR (HBCR‐TAVR) |
Methods |
Parallel‐assignment RCT |
Participants |
Chinese patients after transcatheter aortic valve replacement (TAVR) |
Interventions |
Placebo comparator: control group: routine care Experimental: intervention group: home‐based cardiac rehabilitation |
Outcomes |
Primary outcome measures
Secondary outcome measures
Number of participants to die [Time Frame: 6 weeks, 12 months, number of participants who die during the study due to cardiovascular or non‐cardiovascular causes]
Number of participants re‐hospitalised [Time Frame: 6 weeks, 12 months, number of participants re‐hospitalised during the study]
Number of participants completing home‐based cardiac rehabilitation [Time Frame: 6 weeks, number of participants completing home‐based cardiac rehabilitation]
Cardiac function [Time Frame: 12 months, ejection fraction estimated by echocardiography]
Aortic valve function [Time Frame: 12 months, aortic valve function estimated by echocardiography]
Number of participants injured [Time Frame: 6 weeks, number of participants injured or dying during the course of home‐based cardiac rehabilitation]
Time spent performing activities [Time Frame: 6 weeks, 12 months, number of minutes in a typical week that participants spent performing activities]
6‐minute walk test [Time Frame: 12 months, total distance walked in meters during 6 minutes]
|
Starting date |
9 May 2020 |
Contact information |
Xiaoya Wang, 15715702712 wxyonce@zju.edu.cn
|
Notes |
Estimated enrolment: 300 participants. Estimated study completion date: 31 December 2023 Locations: Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China, 310000 |