Cardiac Rehabilitation
Conditions
Keywords
Virtual Reality, Cardiac Rehabilitation, Cardiac Surgical Procedures
Brief summary
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.
Interventions
DEVICEVirtual 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.
Sponsors
Azienda Ospedaliero Universitaria di Sassari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Rehabilitation Adherence | At completion of the 4-week cardiac rehabilitation program (after the eighth session) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Heart Rate at 4 Weeks | Baseline and 4 weeks (after the eighth rehabilitation session). | Heart rate will be measured using a digital monitor at baseline and after completion of the cardiac rehabilitation program. |
| Change from Baseline in Peripheral Oxygen Saturation at 4 Weeks | Baseline and 4 weeks (after the eighth rehabilitation session). | 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. |
| Change from Baseline in Systolic Blood Pressure at 4 Weeks | Baseline and 4 weeks (after the eighth rehabilitation session). | Systolic Blood Pressure will be measured using a digital monitor at baseline and after completion of the cardiac rehabilitation program. |
| Change from Baseline in Diastolic Blood Pressure at 4 Weeks | 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. |
| Change from Baseline in Kansas City Cardiomyopathy Questionnaire Score at 4 Weeks | Baseline and 4 weeks (after the eighth rehabilitation session). | 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. |
| Change from Baseline in Six-Minute Walk Test Distance at 4 Weeks | Baseline and 4 weeks (after the eighth rehabilitation session) | 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 |
| Change from Baseline in Rating of Perceived Exertion at 4 Weeks | Baseline and 4 weeks (after the eighth rehabilitation session). | 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. |
| Change from Baseline in Canadian Cardiovascular Society Angina Class at 4 Weeks | Baseline and 4 weeks (after the eighth rehabilitation session) | 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. |
| Change from Baseline in Metabolic Equivalents During Cardiopulmonary Exercise Testing at 4 Weeks | Baseline and 4 weeks (after the eighth rehabilitation session). | 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. |
| Change from Baseline in Exercise Workload Capacity During Cardiopulmonary Exercise Testing at 4 Weeks | Baseline and 4 weeks (after the eighth rehabilitation session). | 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. |
| Occurrence of Exercise-Induced Arrhythmias During Cardiopulmonary Exercise Testing | Baseline and 4 weeks (after the eighth rehabilitation session). | 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. |
| Virtual Reality-Related Cybersickness | Immediately after each of the eight virtual reality sessions, over 4 weeks. | 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. |
Countries
Italy
Contacts
CONTACTValentina Micheluzzi, PhD
PRINCIPAL_INVESTIGATORValentina Micheluzzi, PhD
Azienda Ospedaliera Universitaria
Outcome results
None listed