Effects of Virtual Reality-Based Cardiac Rehabilitation in Patients Undergoing Cardiac Surgery
| Registry | NCT07782749, acronym VIRTUAL RIAB |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 46 (Estimated) |
| Sponsor | Azienda Ospedaliero Universitaria di Sassari (Other) |
| Conditions | Cardiac Rehabilitation |
| Interventions | Virtual Reality (Device) |
| Dates | start 2026-09-01 (estimated), primary completion 2029-08-30 (estimated), completion 2029-10-30 (estimated), first posted 2026-08-24, last updated 2026-08-25 |
| Locations | 1 site in Italy |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Virtual Reality arm | Experimental | Device: Virtual Reality | 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. |
| 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. |
Sex: All, ages: 18 Years to 80 Years
Inclusion criteria: * age over 18 years; * a clinically stable cardiovascular diagnosis. Exclusion criteria: * conditions precluding physical exercise (e.g., bone fractures); * conditions precluding the use of virtual reality (e.g., blindness and deafness); * severe cognitive impairment, documented by a score of 0 to 4 on the Six-Item Screener; * end-stage renal disease requiring dialysis; * established advanced pulmonary disease; * active malignancies; * rheumatic diseases.
| Facility | City | Country | Status |
|---|---|---|---|
| SS Annunziata Hospital, Sassari | Sassari, Sardinia | Italy |