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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing Transcatheter Aortic Valve Replacement (REHAB-TAVR): a Randomized Clinical Trial

Conditions
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Cardiac Rehabilitation

Intervention / Treatment
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* Behavioral: Home-based mobile guided exercise-based cardiac rehabilitation
* Behavioral: Routine Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The REHAB-TAVR group<br>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. | Behavioral: Home-based mobile guided exercise-based cardiac rehabilitation<br>* Discharge preparation, telerehabilitation, scheduled onsite follow-ups, telephone follow-ups, self-reporting, health education, online communication, family and peer support, mailing letters, institutional referrals, and security management.<br>|
| Other: The Routine-TAVR group<br>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. | Behavioral: Routine Care<br>* Discharge preparation, scheduled onsite follow-ups, telephone follow-ups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6-minute Walk Distance | Distance walked in 6 minutes | Month 3 | 

Secondary Outcome Measures

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