Virtual Reality-Based Cardiac Rehabilitation in Patients Undergoing Cardiac Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAzienda Ospedaliero Universitaria di Sassari

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age over 18 years;

a clinically stable cardiovascular diagnosis.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality

    Device

    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.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Virtual Reality armExperimental treatment 1 intervention
Group B: Standard Care armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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).
3

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)
4

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).

Other outcomes

Sponsors and contacts

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