Clinical trial NCT06984172: Effectiveness of Remote Cardiac Rehab After Surgery for Acquired Heart Valve Disease
Official title: Effectiveness of Cardiac Rehabilitation With Remote Connection Device for Patients After Surgery for Acquired Heart Valve Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Valvular Diseases
Keywords: phẫu thuật tim
phục hồi chức năng
valvular disease
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximal oxygen uptake
timeFrame: At the beginning of the early recovery phase (typically around 10 days after surgery), at the end of the early rehabilitation phase (immediately before hospital discharge), and one month later
measure: Six-Minute Walk Test
timeFrame: pre-operation, at the beginning of the early recovery phase, at the end of the early rehabilitation phase, and one month later
Secondary outcomes:
measure: Two-minute Step Test
timeFrame: pre-operation, at the beginning of the early recovery phase, at the end of the early rehabilitation phase, and one month later
Other outcomes:
Locations:
city: Hà Nội
country: Vietnam
facility: Hanoi Medical University Hospital
Study officials:
affiliation: Trường Đại học Y Hà Nội
name: Phạm Văn Minh, Assoc. Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Trường Đại học Y Hà Nội
name: Vũ Ngọc Tú, Assoc. Prof. MD
role: PRINCIPAL_INVESTIGATOR
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