[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591726":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":30,"studyPopulation":21,"armGroups":31,"interventions":44,"overallOfficials":58,"centralContacts":65,"locations":71,"responsibleParty":94,"collaborators":21,"id":96,"slug":21,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":21,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":21,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":118,"whyStopped":21,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Hanoi Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":21},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.\n\nVO₂ 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",{"measure":14,"description":15,"timeFrame":16},"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.\n\nThis 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.\n\nHowever, 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.\n\nAmong 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",[18],{"measure":19,"description":20,"timeFrame":16},"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).\n\nTMST 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",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":28},"SINGLE",[29],"PARTICIPANT","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.\n\nAll patients participating in the study receive inpatient cardiac rehabilitation during the acute phase (1 week) and early recovery phase (1 week) at the hospital.\n\nBefore discharge, patients are randomly assigned by dice rolling into the intervention or control group, with a minimum of 22 patients in each group.\n\nThe control group continues supervised outpatient rehabilitation at the hospital, three sessions per week for the following month.\n\nThe 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.\n\nEvery 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).\n\nExercise capacity assessments for both groups are performed at baseline (pre-surgery), after acute phase rehabilitation, before discharge, and one month post-discharge.\n\nEvaluation parameters include: 6-minute walk distance, 2-minute step test, and peak oxygen uptake (VO₂ peak) measured by cardiopulmonary exercise testing (CPET).\n\nCardiac rehabilitation interventions are conducted following the 2021 guidelines of the Japanese Circulation Society.",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"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.\n\nAfter 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.\n\nPhysical 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.",[37],"Procedure: Remote cardiac rehabilitation",{"label":39,"type":40,"description":41,"interventionNames":42},"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.\n\nAfter discharge, patients continue late-phase cardiovascular rehabilitation as outpatients for the following month.\n\nPhysical 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.",[43],"Procedure: Facility-based cardiac rehabilitation",[45,52],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"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.\n\n* 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:\n\n  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.\n  2. Borg Rating of Perceived Exertion (RPE) scale for dyspnea: maintained at 12-13 out of 20.\n* Lower limb resistance training: Performed 3 times per week, each session lasting 30-40 minutes. Intensity is based on the one-repetition maximum (1RM).\n* Breathing exercises: Performed 3 times per week",[33],[51],"home-based cardiac rehabilitation in late recovery phase",{"type":46,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"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.\n\nAerobic 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.\n\nLower limb resistance training: Each session lasts 30-40 minutes.\n\nBreathing exercises: Each session lasts 15-20 minutes",[39],[57],"Late-recovery phase outpatient rehabilitation conducted at a rehabilitation center",[59,63],{"name":60,"affiliation":61,"role":62},"Phạm Văn Minh, Assoc. Prof. MD","Trường Đại học Y Hà Nội","PRINCIPAL_INVESTIGATOR",{"name":64,"affiliation":61,"role":62},"Vũ Ngọc Tú, Assoc. Prof. MD",[66],{"name":67,"role":68,"phone":69,"phoneExt":21,"email":70},"TRỊNH B. TRÂM, MMed","CONTACT","(+84) 354176044","trinhbaotram@hmu.edu.vn",[72],{"facility":73,"status":21,"city":74,"state":21,"zip":21,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Hanoi Medical University Hospital","Hà Nội","Vietnam","VN",{"type":78,"coordinates":79},"Point",[80,81],106.02292,20.47366,{"lat":81,"lon":80},[84,87,91,93],{"name":85,"role":68,"phone":86,"phoneExt":21,"email":70},"TRỊNH B TRÂM, MMED","+84 354176044",{"name":88,"role":68,"phone":89,"phoneExt":21,"email":90},"Phạm V Minh, Assoc. Prof. MD","+84 902251267","pvminhrehab@yahoo.com",{"name":64,"role":92,"phone":21,"phoneExt":21,"email":21},"SUB_INVESTIGATOR",{"name":60,"role":92,"phone":21,"phoneExt":21,"email":21},{"type":95,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100591726",false,"NCT06984172","Effectiveness of Remote Cardiac Rehab After Surgery for Acquired Heart Valve Disease","Effectiveness of Cardiac Rehabilitation With Remote Connection Device for Patients After Surgery for Acquired Heart Valve Disease","Inclusion Criteria:\n\n* 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.\n* Willing to participate in the study.\n\nExclusion Criteria:\n\n* Contraindications to cardiac rehabilitation.\n* Patients who die during the study after hospital discharge.","ALL","18 Years","70 Years",{"count":106,"type":107},44,"ESTIMATED","INTERVENTIONAL",[110],"NA","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.\n\nThe main questions it seeks to answer are:\n\n* How does cardiac rehabilitation using remote monitoring devices improve exercise capacity in participants compared to those undergoing rehabilitation at medical facilities?\n* 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.\n\nAll 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.\n\nThe control group continues supervised outpatient rehabilitation at the hospital, three sessions per week for the following month.\n\nThe 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.\n\nBoth groups are assessed for exercise capacity at baseline (pre-surgery), after each phase of rehabilitation, and one month after hospital discharge.",[113],"Valvular Diseases",[115,116,117],"phẫu thuật tim","phục hồi chức năng","valvular disease","NOT_YET_RECRUITING","2025-05-19",{"date":121,"type":122},"2025-05-22","ACTUAL",{"date":124,"type":107},"2025-06-01",{"date":126,"type":107},"2026-06-30",{"name":5,"class":6},1]