Effectiveness of Remote Cardiac Rehab After Surgery for Acquired Heart Valve Disease
NCT ID: NCT06984172
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
44 participants
INTERVENTIONAL
2025-06-01
2026-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
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.
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:
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
Control group
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.
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 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
Interventions
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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:
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 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 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to participate in the study.
Exclusion Criteria
* Patients who die during the study after hospital discharge.
18 Years
70 Years
ALL
No
Sponsors
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Hanoi Medical University
OTHER
Responsible Party
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Principal Investigators
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Phạm Văn Minh, Assoc. Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Trường Đại học Y Hà Nội
Vũ Ngọc Tú, Assoc. Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Trường Đại học Y Hà Nội
Locations
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Hanoi Medical University Hospital
Hà Nội, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Razvi Y, Ladie DE. Cardiopulmonary Exercise Testing. 2023 Apr 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557886/
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.
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.
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.
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.
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.
Tessler J, Ahmed I, Bordoni B. Cardiac Rehabilitation. 2025 Mar 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537196/
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.
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.
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.
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.
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.
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.
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.
Xue W, Xinlan Z, Xiaoyan Z. Effectiveness of early cardiac rehabilitation in patients with heart valve surgery: a randomized, controlled trial. J Int Med Res. 2022 Jul;50(7):3000605211044320. doi: 10.1177/03000605211044320.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HMUIBR1880
Identifier Type: -
Identifier Source: org_study_id
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