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

NCT06984172 | Not Yet Recruiting

• 1 other identifier: HMUIBR1880
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Valvular Diseases

Keywords

phẫu thuật tim; phục hồi chức năng; valvular disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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.

  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)

• Two-minute Step Test

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Procedure: Remote cardiac rehabilitation

Control group

ACTIVE COMPARATOR

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.

Procedure: Facility-based cardiac rehabilitation

Interventions

Remote cardiac rehabilitation PROCEDURE

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

Also known as: home-based cardiac rehabilitation in late recovery phase

Intervention group

Facility-based cardiac rehabilitation PROCEDURE

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

Also known as: Late-recovery phase outpatient rehabilitation conducted at a rehabilitation center

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi Medical University Hospital

Hà Nội, Vietnam

Location

Related Publications (18)

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• 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.

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• 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.

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• 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.

  PMID: 33323210 RESULT

• 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.

  PMID: 32106713 RESULT

• Sibilitz KL, Tang LH, Berg SK, Thygesen LC, Risom SS, Rasmussen TB, Schmid JP, Borregaard B, Hassager C, Kober L, Taylor RS, Zwisler AD. Long-term effects of cardiac rehabilitation after heart valve surgery - results from the randomised CopenHeartVR trial. Scand Cardiovasc J. 2022 Dec;56(1):247-255. doi: 10.1080/14017431.2022.2095432.

  PMID: 35811477 RESULT

• Makita S, Yasu T, Akashi YJ, Adachi H, Izawa H, Ishihara S, Iso Y, Ohuchi H, Omiya K, Ohya Y, Okita K, Kimura Y, Koike A, Kohzuki M, Koba S, Sata M, Shimada K, Shimokawa T, Shiraishi H, Sumitomo N, Takahashi T, Takura T, Tsutsui H, Nagayama M, Hasegawa E, Fukumoto Y, Furukawa Y, Miura SI, Yasuda S, Yamada S, Yamada Y, Yumino D, Yoshida T, Adachi T, Ikegame T, Izawa KP, Ishida T, Ozasa N, Osada N, Obata H, Kakutani N, Kasahara Y, Kato M, Kamiya K, Kinugawa S, Kono Y, Kobayashi Y, Koyama T, Sase K, Sato S, Shibata T, Suzuki N, Tamaki D, Yamaoka-Tojo M, Nakanishi M, Nakane E, Nishizaki M, Higo T, Fujimi K, Honda T, Matsumoto Y, Matsumoto N, Miyawaki I, Murata M, Yagi S, Yanase M, Yamada M, Yokoyama M, Watanabe N, Itoh H, Kimura T, Kyo S, Goto Y, Nohara R, Hirata KI; Japanese Circulation Society/the Japanese Association of Cardiac Rehabilitation Joint Working Group. JCS/JACR 2021 Guideline on Rehabilitation in Patients With Cardiovascular Disease. Circ J. 2022 Dec 23;87(1):155-235. doi: 10.1253/circj.CJ-22-0234. Epub 2022 Dec 9. No abstract available.

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Study Officials

• Phạm Văn Minh, Assoc. Prof. MD

  Trường Đại học Y Hà Nội

  PRINCIPAL INVESTIGATOR

• Vũ Ngọc Tú, Assoc. Prof. MD

  Trường Đại học Y Hà Nội

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TRỊNH B. TRÂM, MMed

CONTACT

(+84) 354176044; trinhbaotram@hmu.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 22, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-04

Locations

VN (1)