[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653181":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":53,"studyPopulation":53,"armGroups":60,"interventions":71,"overallOfficials":80,"centralContacts":85,"locations":90,"responsibleParty":104,"collaborators":53,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":53,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":129,"whyStopped":53,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Azienda Ospedaliero Universitaria di Sassari","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"Cardiac Rehabilitation Adherence","Cardiac rehabilitation adherence will be measured as the percentage of scheduled rehabilitation sessions completed by each participant. Adherence will be calculated as the number of completed sessions divided by the total number of eight scheduled sessions, multiplied by 100. Higher percentages indicate greater adherence.","At completion of the 4-week cardiac rehabilitation program (after the eighth session)",[14,18,22,25,28,31,34,37,40,43,46,49],{"measure":15,"description":16,"timeFrame":17},"Change from Baseline in Six-Minute Walk Test Distance at 4 Weeks","Functional capacity will be assessed using the Six-Minute Walk Test. Participants will be instructed to walk at their own pace for 6 minutes on a flat, hard surface and to cover the greatest possible distance. The outcome will be the total distance walked, expressed in meters. A greater distance indicates better functional capacity","Baseline and 4 weeks (after the eighth rehabilitation session)",{"measure":19,"description":20,"timeFrame":21},"Change from Baseline in Rating of Perceived Exertion at 4 Weeks","Perceived exertion will be assessed using the Borg Rating of Perceived Exertion Scale. The scale ranges from 6 to 20, where 6 corresponds to no exertion and 20 corresponds to maximal exertion. The Borg score will be recorded at baseline and after completion of the cardiac rehabilitation program.","Baseline and 4 weeks (after the eighth rehabilitation session).",{"measure":23,"description":24,"timeFrame":17},"Change from Baseline in Canadian Cardiovascular Society Angina Class at 4 Weeks","Angina severity will be assessed using the Canadian Cardiovascular Society classification of angina pectoris. The classification ranges from Class I, indicating no limitation of ordinary physical activity, to Class IV, indicating inability to perform physical activity without discomfort. Higher classes indicate greater functional limitation due to angina.",{"measure":26,"description":27,"timeFrame":21},"Change from Baseline in Metabolic Equivalents During Cardiopulmonary Exercise Testing at 4 Weeks","Exercise capacity will be assessed by cardiopulmonary exercise testing. Metabolic equivalents will be recorded during cardiopulmonary exercise testing at baseline and after completion of the cardiac rehabilitation program.",{"measure":29,"description":30,"timeFrame":21},"Change from Baseline in Exercise Workload Capacity During Cardiopulmonary Exercise Testing at 4 Weeks","Exercise workload capacity will be assessed during cardiopulmonary exercise testing at baseline and after completion of the cardiac rehabilitation program. The workload achieved during testing will be compared between the two assessment time points.",{"measure":32,"description":33,"timeFrame":21},"Occurrence of Exercise-Induced Arrhythmias During Cardiopulmonary Exercise Testing","The presence or absence of exercise-induced arrhythmias will be assessed during cardiopulmonary exercise testing at baseline and after completion of the cardiac rehabilitation program.",{"measure":35,"description":36,"timeFrame":21},"Change from Baseline in Heart Rate at 4 Weeks","Heart rate will be measured using a digital monitor at baseline and after completion of the cardiac rehabilitation program.",{"measure":38,"description":39,"timeFrame":21},"Change from Baseline in Peripheral Oxygen Saturation at 4 Weeks","Peripheral oxygen saturation will be measured using a digital monitor at baseline and after completion of the cardiac rehabilitation program and will be expressed as a percentage.",{"measure":41,"description":42,"timeFrame":21},"Change from Baseline in Systolic Blood Pressure at 4 Weeks","Systolic Blood Pressure will be measured using a digital monitor at baseline and after completion of the cardiac rehabilitation program.",{"measure":44,"description":45,"timeFrame":44},"Change from Baseline in Diastolic Blood Pressure at 4 Weeks","Diastolic Blood Pressure will be measured using a digital monitor at baseline and after completion of the cardiac rehabilitation program.",{"measure":47,"description":48,"timeFrame":21},"Change from Baseline in Kansas City Cardiomyopathy Questionnaire Score at 4 Weeks","Health-related quality of life will be assessed using the 23-item Kansas City Cardiomyopathy Questionnaire. The questionnaire evaluates physical function, symptoms, social function, self-efficacy, and quality of life. Scores range from 0 to 100, with higher scores representing better health status.",{"measure":50,"description":51,"timeFrame":52},"Virtual Reality-Related Cybersickness","Cybersickness will be assessed in participants assigned to the virtual reality group using the 13-item Virtual Reality Symptom Questionnaire (VRSQ). The questionnaire comprises 8 non-ocular and 5 ocular symptoms. Each item is rated on a 7-point scale from 0 to 6, where 0 indicates no symptoms, 1-2 slight symptoms, 3-4 moderate symptoms, and 5-6 severe symptoms. Item scores will be summed to obtain a total VRSQ score ranging from 0 to 78, with higher scores indicating greater severity of virtual reality-related symptoms. Non-ocular and ocular subscores range from 0 to 48 and 0 to 30, respectively.","Immediately after each of the eight virtual reality sessions, over 4 weeks.",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":59,"maskingDescription":53,"whoMasked":53},"NONE",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"Virtual Reality arm","EXPERIMENTAL","We will use the latest generation of high-quality immersive virtual reality (VR) technology, featuring high integrated computing power, standalone operation, sophisticated software, and advanced optical components, thereby ensuring low latency and a wide field of view. The virtual scenarios selected will consist of natural environments, as interaction with such settings has been shown to provide a highly effective form of distraction. To further enhance the immersive experience, auditory sensory stimulation will also be incorporated.The selected audio content will consist of natural sounds and will be delivered directly through the headset in high-definition stereo to provide a fully immersive audiovisual experience. Devices that meet these requirements while offering a favorable cost-effectiveness profile include the PICO 4® headset and the TREADMILL XR® application. VR will be administered during the 30-minute cardiac rehabilitation (CR) session, under the supervision.",[66],"Device: Virtual Reality",{"label":68,"type":69,"description":70,"interventionNames":53},"Standard Care arm","NO_INTERVENTION","Patients in the control group will undergo cardiac rehabilitation on a treadmill or stationary bicycle under the supervision of healthcare professionals, following the same guidelines as the intervention group in terms of the number of sessions, session duration, and exercise intensity, but without the use of virtual reality.",[72],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"DEVICE","Virtual Reality","Participants assigned to the intervention group will undergo cardiac rehabilitation while using immersive virtual reality. During each cardiac rehabilitation session, participants will wear an immersive virtual reality headset providing high-quality three-dimensional natural environments combined with natural high-definition stereo audio to enhance the immersive audiovisual experience. The virtual reality system may include the PICO 4® headset and the TREADMILL XR® application. Virtual reality will be provided throughout the 30-minute rehabilitation session under the supervision of a healthcare professional trained in virtual reality technology. Before the first session, participants will receive approximately 10 minutes of instruction and demonstration on the use of the virtual reality equipment. During the sessions, participants will be allowed to freely move their eyes and head, adjust the audio volume, and discontinue virtual reality at any time.",[62],[78,79],"Immersive Virtual Reality","Virtual Reality-Assisted Cardiac Rehabilitation",[81],{"name":82,"affiliation":83,"role":84},"Valentina Micheluzzi, PhD","Azienda Ospedaliera Universitaria","PRINCIPAL_INVESTIGATOR",[86],{"name":82,"role":87,"phone":88,"phoneExt":53,"email":89},"CONTACT","+ 39 3401753630","valentina.micheluzzi@aousassari.it",[91],{"facility":92,"status":53,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":53},"SS Annunziata Hospital, Sassari","Sassari","Sardinia","07100","Italy","IT",{"type":99,"coordinates":100},"Point",[101,102],8.55552,40.72586,{"lat":102,"lon":101},{"type":84,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Valentina Micheluzzi","Principal Investigator","100653181","virtual-reality-based-cardiac-rehabilitation-in-patients-undergoing-cardiac-surgery-100653181",false,"NCT07782749","Virtual Reality-Based Cardiac Rehabilitation in Patients Undergoing Cardiac Surgery","Effects of Virtual Reality-Based Cardiac Rehabilitation in Patients Undergoing Cardiac Surgery","VIRTUAL RIAB","Inclusion criteria:\n\n* age over 18 years;\n* a clinically stable cardiovascular diagnosis.\n\nExclusion criteria:\n\n* conditions precluding physical exercise (e.g., bone fractures);\n* conditions precluding the use of virtual reality (e.g., blindness and deafness);\n* severe cognitive impairment, documented by a score of 0 to 4 on the Six-Item Screener;\n* end-stage renal disease requiring dialysis;\n* established advanced pulmonary disease;\n* active malignancies;\n* rheumatic diseases.","ALL","18 Years","80 Years",{"count":119,"type":120},46,"ESTIMATED","INTERVENTIONAL",[123],"NA","This randomized controlled study will evaluate whether adding immersive virtual reality (VR) to cardiac rehabilitation can improve participation in rehabilitation and other health outcomes in patients who have recently undergone cardiac surgery.\n\nCardiac rehabilitation is recommended after cardiac surgery to support recovery, improve physical function and quality of life, and reduce complications related to physical inactivity. However, some patients have difficulty completing the recommended rehabilitation program. Immersive VR may make exercise sessions more engaging and may help patients participate more consistently in their rehabilitation.\n\nThe study will enroll 46 adult patients who have undergone cardiac surgery within the previous 30 days, are clinically stable, and have an indication for cardiac rehabilitation. Participants will be randomly assigned in a 1:1 ratio to either an immersive VR group or a standard cardiac rehabilitation group.\n\nParticipants in both groups will complete the same supervised cardiac rehabilitation program, consisting of eight moderate-intensity exercise sessions performed on a treadmill or stationary bicycle. Each session will last approximately 30 minutes and will be performed twice a week for four weeks.\n\nParticipants assigned to the VR group will perform their rehabilitation sessions while wearing an immersive VR headset. The headset will provide natural audiovisual environments designed to create an immersive experience during exercise. A trained healthcare professional will assist participants with the technology and supervise them throughout each session. Participants will be able to stop the VR experience at any time if needed. Participants assigned to the control group will complete the same rehabilitation program without VR.\n\nThe primary outcome of the study is adherence to cardiac rehabilitation, measured as the percentage of scheduled rehabilitation sessions completed.\n\nSecondary outcomes will assess changes from baseline to the end of the rehabilitation program in functional capacity using the 6-minute walk test, perceived exertion using the Borg scale, angina severity, cardiopulmonary exercise test parameters, heart rate, blood pressure, oxygen saturation, and health-related quality of life using the Kansas City Cardiomyopathy Questionnaire.\n\nIn the VR group, symptoms potentially related to VR exposure, known as cybersickness, will be assessed after each session using the Virtual Reality Symptom Questionnaire. At the end of the program, participants in the VR group will also be invited to take part in a semi-structured interview about their experience with virtual reality.\n\nThe study aims to determine whether immersive VR can be a useful approach to support participation in cardiac rehabilitation after cardiac surgery while also evaluating its effects on physical, clinical, and patient-reported outcomes.",[126],"Cardiac Rehabilitation",[74,126,128],"Cardiac Surgical Procedures","NOT_YET_RECRUITING","2026-08-22",{"date":132,"type":133},"2026-08-25","ACTUAL",{"date":135,"type":120},"2026-09-01",{"date":137,"type":120},"2029-10-30",{"name":5,"class":6},1]