Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing TAVR

Not Applicable

Not yet recruiting

• Conditions: Cardiac Rehabilitation
• Interventions: Behavioral: Routine Care; Behavioral: Home-based mobile guided exercise-based cardiac rehabilitation

• Registration Number: NCT05989594
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

A two-parallel, evaluator-blind, single-center, randomized controlled trial was designed to assess the effectiveness of a home-based mobile guided exercise-based cardiac rehabilitation among patients undergoing Transcatheter Aortic Valve Replacement.

Detailed Description

The purpose of our study was to investigate the effect of home-based mobile-guided exercise-based cardiac rehabilitation on the improvement of exercise capacity among patients undergoing transcatheter aortic valve replacement. 90 subjects will be recruited and followed up for a six-minute walk distance, short physical performance battery, exercise adherence, quality of life, frailty, nutritional status, sleep status, readmission rate, and all-cause mortality et al. The subjects will be invited to participate in on-site visits at 1, 3, and 6 months. Patients in the interventional group will receive a home-based mobile-guided exercise-based cardiac rehabilitation for 3 months. The home-based mobile-guided exercise-based cardiac rehabilitation is a multi-component intervention strategy including the preparation for discharge, family support, motivational interviews, health education, telephone follow-up, wearable devices, APP, et al. While the patients in the control group will receive routine care. For example, the preparation for discharge of the control group does not include the guidance of mobile-guided exercise-based cardiac rehabilitation, family support, and motivational interviews. After discharge, nurses will conduct telephone follow-ups once a month for the control group. Baseline data and outcomes will be collected in a Case Report Form.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14
• Study Start: 2023-09-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Age ≥ 60 years and ≤ 89 years old;
• Patients scheduled to be discharged after TAVR;
• Those who have the ability to read and write, and have normal speech and communication skills;
• Patients and their families are willing to participate in this study;
• Patients or family members have the ability to use mobile and an app.

Exclusion Criteria

• Serious complications occur before discharge (such as major bleeding, stroke, valve detachment, moderate or above perivalve leakage, coronary artery occlusion, etc.) ;
• Patients who are unable to participate in postoperative exercise rehabilitation due to limb dysfunction;
• Being in palliative care or treatment;
• Those with other Contraindication to exercise-based cardiac rehabilitation (such as resting ECG changes indicating significant ischemia, acute myocardial infarction or other acute cardiac events, unstable angina, uncontrolled arrhythmia, heart failure decompensation, etc.);
• Currently participating in other rehabilitation projects.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Routine-TAVR group	Routine Care	Preparation for discharge will only involve an exercise endurance test and the guidance of an exercise prescription for the Routine-TAVR group. Following discharge, nurses will conduct monthly telephone follow-ups to check on the patient's progress. Additionally, patients will be scheduled for onsite follow-ups at the Outpatient Department.
The REHAB-TAVR group	Home-based mobile guided exercise-based cardiac rehabilitation	For the REHAB-TAVR group, discharge preparation will involve an exercise endurance test, exercise prescription guidance, motivational interviews, instruction on telerehabilitation, and the provision of family and peer support. Following discharge, patients will be required to adhere to their personalized exercise prescription and attend scheduled onsite follow-ups after discharge. The management model employed for this group is called home-based mobile guided exercise-based cardiac rehabilitation.

Primary Outcome Measures

Name	Time	Method
Change in 6-minute Walk Distance	Month 3	Distance walked in 6 minutes

Secondary Outcome Measures

Name	Time	Method
Change in Short Physical Performance Battery (SPPB)	Month 3 and Month 6	The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function.
Change in 6-minute Walk Distance	Month 6	Distance walked in 6 minutes
Exercise Adherence Assessed by the Exercise Adherence Rating Scale (EARS)	Month1, Month 3 and Month 6	Evaluated by the Exercise Adherence Rating Scale (EARS)