NCT06984172

Effectiveness of Remote Cardiac Rehab After Surgery for Acquired Heart Valve Disease

Effectiveness of Cardiac Rehabilitation With Remote Connection Device for Patients After Surgery for Acquired Heart Valve Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Hanoi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if home-based cardiac rehabilitation using remote monitoring devices improves exercise capacity in patients after surgery for acquired heart valve diseases. It also aims to learn about factors affecting the outcomes of remote treatment. The main questions it seeks to answer are: * How does cardiac rehabilitation using remote monitoring devices improve exercise capacity in participants compared to those undergoing rehabilitation at medical facilities? * What factors influence the outcomes of participants undergoing cardiac rehabilitation with remote monitoring devices? The researchers compare the exercise capacity of the intervention group - receiving home-based cardiac rehabilitation using remote monitoring devices - with that of the control group receiving treatment at a rehabilitation facility during the recovery phase. All patients participating in the study receive inpatient cardiac rehabilitation during the acute phase (1 week) and the early recovery phase (1 week) at the hospital. The control group continues supervised outpatient rehabilitation at the hospital, three sessions per week for the following month. The intervention group undergoes home-based rehabilitation under the guidance of a therapist via the Open TeleRehab platform and self-monitors hemodynamic parameters using a personal blood pressure monitor and a handheld pulse oximeter. Both groups are assessed for exercise capacity at baseline (pre-surgery), after each phase of rehabilitation, and one month after hospital discharge.

Detailed description

This is a prospective, randomized, controlled, single-blind interventional study. We conduct the study on patients aged 18 years and older diagnosed with acquired heart valve diseases who have an indication for valve repair or replacement surgery at the Cardiovascular Center - Hanoi Medical University Hospital. All patients participating in the study receive inpatient cardiac rehabilitation during the acute phase (1 week) and early recovery phase (1 week) at the hospital. Before discharge, patients are randomly assigned by dice rolling into the intervention or control group, with a minimum of 22 patients in each group. The control group continues supervised outpatient rehabilitation at the hospital, three sessions per week for the following month. The intervention group undergoes home-based rehabilitation and self-monitors their hemodynamic parameters using a personal blood pressure monitor and a handheld pulse oximeter. Before and after each training session, patients send images of their vital signs (heart rate, blood pressure, SpO₂) to the physician via the Open TeleRehab platform. The physician immediately provides feedback if adjustments to the exercise session (intensity, duration, type) are necessary. Every Saturday, physicians and patients conduct a group meeting via the Open TeleRehab platform to discuss any issues arising during the training sessions (approximately 30 minutes). Exercise capacity assessments for both groups are performed at baseline (pre-surgery), after acute phase rehabilitation, before discharge, and one month post-discharge. Evaluation parameters include: 6-minute walk distance, 2-minute step test, and peak oxygen uptake (VO₂ peak) measured by cardiopulmonary exercise testing (CPET). Cardiac rehabilitation interventions are conducted following the 2021 guidelines of the Japanese Circulation Society.

Conditions

• Valvular Diseases

Interventions

Type	Name	Description
PROCEDURE	Remote cardiac rehabilitation	The patient, following heart valve surgery, is undergoing home-based cardiovascular rehabilitation during the late recovery phase. The rehabilitation is remotely supervised by a therapist through the Open TeleRehab software and includes aerobic exercises, breathing exercises, and lower limb resistance training. * Aerobic exercise: Performed 3 times per week, each session lasting 20-40 minutes. Activities include walking, stair climbing, or cycling. Exercise intensity is determined based on: 1. Target heart rate: Set at the anaerobic threshold identified through Cardiopulmonary Exercise Testing (CPET) prior to hospital discharge; heart rate is monitored using a handheld pulse oximeter. 2. Borg Rating of Perceived Exertion (RPE) scale for dyspnea: maintained at 12-13 out of 20. * Lower limb resistance training: Performed 3 times per week, each session lasting 30-40 minutes. Intensity is based on the one-repetition maximum (1RM). * Breathing exercises: Performed 3 times per week
PROCEDURE	Facility-based cardiac rehabilitation	After completing inpatient rehabilitation, patients are discharged and continue supervised outpatient rehabilitation three times per week. The program includes aerobic exercise, lower limb resistance training, and breathing exercises. Aerobic exercise: Each session lasts 20-40 minutes, depending on the patient's condition, and is performed using a Cardiopulmonary Exercise Testing (CPET) device. Exercise intensity is determined based on the target heart rate and the Borg Rating of Perceived Exertion (RPE) scale for dyspnea and fatigue, in accordance with the 2021 guidelines of the Japanese Circulation Society. Lower limb resistance training: Each session lasts 30-40 minutes. Breathing exercises: Each session lasts 15-20 minutes

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-05-15
• Completion: 2026-06-30
• First posted: 2025-05-22
• Last updated: 2025-05-22

Locations

1 site across 1 country: Vietnam