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Valvular DiseasesNCT06984172

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

A study testing Remote cardiac rehabilitation and Facility-based cardiac rehabilitation in people with Valvular Diseases, run by Hanoi Medical University at 1 site in Vietnam.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Valvular Diseases
What is being tested?
Remote cardiac rehabilitation and Facility-based cardiac rehabilitation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteVietnam
Study dates
1 Jun 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

TRỊNH B. TRÂM, MMed contact

(+84) 354176044

trinhbaotram@hmu.edu.vn

Vietnam1 site

  • Hanoi Medical University Hospital

    Hà Nội

    TRỊNH B TRÂM, MMED, +84 354176044, trinhbaotram@hmu.edu.vn

    Phạm V Minh, Assoc. Prof. MD, +84 902251267, pvminhrehab@yahoo.com

Other trials in Vietnam

About this study

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

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:

Read more
  • 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.

Read the 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.

Being tested
Remote cardiac rehabilitation, Facility-based cardiac rehabilitation
Keywords
phẫu thuật tim, phục hồi chức năng, valvular disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote cardiac rehabilitationProcedure or surgery

    Also called home-based cardiac rehabilitation in late recovery phase

    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

  • Facility-based cardiac rehabilitationProcedure or surgery

    Also called Late-recovery phase outpatient rehabilitation conducted at a rehabilitation center

    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

Study groups in NCT06984172
Study groupRoleWhat they receive
Intervention groupExperimentalUndergoes 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.
Receives: Procedure: Remote cardiac rehabilitation
Control groupActive comparatorUndergoes 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.
Receives: Procedure: Facility-based cardiac rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal oxygen uptake

    Maximal oxygen uptake (VO₂ max) refers to the maximum amount of oxygen that an individual can utilize during intense or maximal exercise. And it is a gold standard indicator of cardiovascular and respiratory system efficiency.

    VO₂ max is typically measured using cardiopulmonary exercise testing (CPET). Higher VO₂ max values are associated with better cardiovascular health, lower risk of heart disease, and greater endurance.

    Measured: 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

  2. Six-Minute Walk Test

    Six-Minute Walk Test (6MWT) is used widely due to its simplicity and reproducibility, delivering a consolidated image of the cardiopulmonary and musculoskeletal response to exercise.

    This test accurately measures the maximum distance a person can walk in 6 minutes. It requires only simple, commonly available equipment such as a pulse oximeter, a portable oxygen device (to be used if needed by the patient), a chair, a validated dyspnea scale (e.g., the Borg scale), and a stopwatch.

    However, the study cannot identify the cause of dyspnea, or hypoxemia, or the mechanisms underlying a particular patient's exercise intolerance. Because of this, we conduct both 6MWT and Cardiopulmonary Exercise Testing (CPET) on this research.

    Among healthy individuals, the average 6MWT is between 400 and 700 meters.

    Measured: pre-operation, at the beginning of the early recovery phase, at the end of the early rehabilitation phase, and one month later

Secondary outcomes (1)

  1. Two-minute Step Test

    The 2-minute step test is one of the physical capacity assessments, introduced since 1999. The advantages of TMST are that it is safe, does not require a large space, is quick to perform and does not require expensive equipment, has high test-retest reliability (0.9 - Rikli's study), is highly sensitive, and has a small learning effect. Disadvantages: the implementation method is inconsistent in previous studies (some studies count the number of steps of both legs, some studies only count the number of steps of the right leg).

    TMST has been studied and shown to correlate well with other physical capacity assessments such as 1-mile walking time, 6MWT. The results differ between age groups and genders How to perform (as first described by Rikli): count the number of times the patient steps in place, raising the knee to the midpoint of the line connecting the iliac crest to the patella, in 2 minutes. In this study, the assessor counted the number of steps that met the standard for both

    Measured: pre-operation, at the beginning of the early recovery phase, at the end of the early rehabilitation phase, and one month later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion15 May 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06984172
Sponsor's protocol ID
HMUIBR1880
Status last verified
Apr 2025
First submitted
11 May 2025
Last updated
22 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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/

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 37505146

  • Pavy B, Iliou MC, Meurin P, Tabet JY, Corone S; Functional Evaluation and Cardiac Rehabilitation Working Group of the French Society of Cardiology. Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. Arch Intern Med. 2006 Nov 27;166(21):2329-34. doi: 10.1001/archinte.166.21.2329.

    PubMed 17130385

  • Tessler J, Ahmed I, Bordoni B. Cardiac Rehabilitation. 2025 Mar 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537196/

    PubMed 30725881

  • Kang YR, Kim JS, Cha YK, Jeong YJ. Imaging findings of complications after thoracic surgery. Jpn J Radiol. 2019 Mar;37(3):209-219. doi: 10.1007/s11604-018-00806-y. Epub 2019 Jan 12.

    PubMed 30637569

  • Popovici M, Ursoniu S, Feier H, Mocan M, Tomulescu OMG, Kundnani NR, Valcovici M, Dragan SR. Benefits of Using Smartphones and Other Digital Methods in Achieving Better Cardiac Rehabilitation Goals: A Systematic Review and Meta-Analysis. Med Sci Monit. 2023 May 5;29:e939132. doi: 10.12659/MSM.939132.

    PubMed 37143317

  • Aluru JS, Barsouk A, Saginala K, Rawla P, Barsouk A. Valvular Heart Disease Epidemiology. Med Sci (Basel). 2022 Jun 15;10(2):32. doi: 10.3390/medsci10020032.

    PubMed 35736352

  • Dorje T, Zhao G, Tso K, Wang J, Chen Y, Tsokey L, Tan BK, Scheer A, Jacques A, Li Z, Wang R, Chow CK, Ge J, Maiorana A. Smartphone and social media-based cardiac rehabilitation and secondary prevention in China (SMART-CR/SP): a parallel-group, single-blind, randomised controlled trial. Lancet Digit Health. 2019 Nov;1(7):e363-e374. doi: 10.1016/S2589-7500(19)30151-7. Epub 2019 Oct 10.

    PubMed 33323210

  • Lunde P, Bye A, Bergland A, Grimsmo J, Jarstad E, Nilsson BB. Long-term follow-up with a smartphone application improves exercise capacity post cardiac rehabilitation: A randomized controlled trial. Eur J Prev Cardiol. 2020 Nov;27(16):1782-1792. doi: 10.1177/2047487320905717. Epub 2020 Feb 28.

    PubMed 32106713

Questions about this trial

What is this clinical trial studying?

A study testing Remote cardiac rehabilitation and Facility-based cardiac rehabilitation in people with Valvular Diseases, run by Hanoi Medical University at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact TRỊNH B. TRÂM, MMed ((+84) 354176044, trinhbaotram@hmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06984172, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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