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

Hanoi Medical University

Status: Not yet enrolling

Conditions: Valvular Diseases

Treatments: Procedure: Facility-based cardiac rehabilitation; Procedure: Remote cardiac rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06984172

HMUIBR1880

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing first-time surgery for acquired heart valve diseases (valve replacement or repair), including the aortic valve, mitral valve, tricuspid valve, pulmonary valve, or a combination of these valves.
• Willing to participate in the study.

Exclusion criteria

• Contraindications to cardiac rehabilitation.
• Patients who die during the study after hospital discharge.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Intervention group

Experimental group

Description:

Undergoes acute-phase rehabilitation training for approximately 1 week immediately after surgery, then transitions to early recovery-phase rehabilitation for about another week at the hospital. After discharge, patients continue to be monitored and guided in their rehabilitation exercises according to the Japanese Circulation Society's protocol (2021) for 1 month (in late recovery phase) through the Open TeleRehab software. Physical capacity assessments are conducted at several time points: before surgery, at the end of the acute-phase rehabilitation (beginning of the early recovery phase), at hospital discharge (end of the early recovery phase), and one month after discharge.

Treatment:

Procedure: Remote cardiac rehabilitation

Control group

Active Comparator group

Description:

Undergoes acute-phase rehabilitation training for approximately 1 week immediately after surgery, then transitions to early recovery-phase rehabilitation for about another week at the hospital. After discharge, patients continue late-phase cardiovascular rehabilitation as outpatients for the following month. Physical capacity assessments are conducted at several time points: before surgery, at the end of the acute-phase rehabilitation (beginning of the early recovery phase), at hospital discharge (end of the early recovery phase), and one month after discharge.

Treatment:

Procedure: Facility-based cardiac rehabilitation