An interventional study of Virtual Reality in Cardiac Rehabilitation, sponsored by Azienda Ospedaliero Universitaria di Sassari. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Azienda Ospedaliero Universitaria di Sassari · Not applicable, Interventional, and Supportive care
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.
Cardiac 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.
The 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.
Participants 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.
Participants 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.
The primary outcome of the study is adherence to cardiac rehabilitation, measured as the percentage of scheduled rehabilitation sessions completed.
Secondary 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.
In 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.
The 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.
Azienda Ospedaliero Universitaria di Sassari is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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Exclusion criteria:
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Virtual Reality
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.
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.
Also known as: Immersive Virtual Reality, Virtual Reality-Assisted Cardiac Rehabilitation
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.
Time frame: At completion of the 4-week cardiac rehabilitation program (after the eighth session)
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
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session)
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.
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
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.
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session)
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.
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
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.
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
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.
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
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.
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
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.
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
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.
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
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.
Time frame: Change from Baseline in Diastolic Blood Pressure at 4 Weeks
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.
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
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.
Time frame: Immediately after each of the eight virtual reality sessions, over 4 weeks.
Plan to share: Undecided
Start is estimated for Sep 2026; primary completion for Aug 2029, 35 months later.
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Azienda Ospedaliero Universitaria di Sassari