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

Overview

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.

Interventions

• 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:
• 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 Exer

Primary outcome measures

• Maximal oxygen uptake [Time frame: 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]
• Six-Minute Walk Test [Time frame: pre-operation, at the beginning of the early recovery phase, at the end of the early rehabilitation phase, and one month later]

Secondary outcome measures (1)

• Two-minute Step Test [Time frame: pre-operation, at the beginning of the early recovery phase, at the end of the early rehabilitation phase, and one month later]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Vietnam · 1 center

• Hanoi Medical University Hospital — Hà Nội

Publications

• Bohannon RW, Crouch RH. Two-Minute Step Test of Exercise Capacity: Systematic Review of Procedures, Performance, and Clinimetric Properties. J Geriatr Phys Ther. 2019 Apr/Jun;42(2):105-112. doi: 10.1519/JPT.0000000000000164. PMID 29210933
• Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2. PMID 31689414
• Pritchard A, Burns P, Correia J, Jamieson P, Moxon P, Purvis J, Thomas M, Tighe H, Sylvester KP. ARTP statement on cardiopulmonary exercise testing 2021. BMJ Open Respir Res. 2021 Nov;8(1):e001121. doi: 10.1136/bmjresp-2021-001121. PMID 34782330
• Keyes D, Ladie DE. Cardiopulmonary Exercise Testing. 2023 Apr 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557886/ PMID 32491809
• Adachi H. Cardiopulmonary Exercise Test. Int Heart J. 2017 Oct 21;58(5):654-665. doi: 10.1536/ihj.17-264. Epub 2017 Sep 30. PMID 28966333
• McDonagh ST, Dalal H, Moore S, Clark CE, Dean SG, Jolly K, Cowie A, Afzal J, Taylor RS. Home-based versus centre-based cardiac rehabilitation. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD007130. doi: 10.1002/14651858.CD007130.pub5. PMID 37888805
• Hansen TB, Zwisler AD, Berg SK, Sibilitz KL, Thygesen LC, Kjellberg J, Doherty P, Oldridge N, Sogaard R. Cost-utility analysis of cardiac rehabilitation after conventional heart valve surgery versus usual care. Eur J Prev Cardiol. 2017 May;24(7):698-707. doi: 10.1177/2047487317689908. Epub 2017 Jan 25. PMID 28121172
• Li Z, Song W, Yang N, Ding Y. Exercise-based cardiac rehabilitation programmers for patients after transcatheter aortic valve implantation: A systematic review and meta-analysis. Medicine (Baltimore). 2023 Jul 28;102(30):e34478. doi: 10.1097/MD.0000000000034478. PMID 37505146

Identifiers

NCT: NCT06984172 · HMUIBR1880

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗