Psychometric and Physiological Assessment of the Effects of Vir-tual Reality in Cardiovascular Rehabilitation

NCT ID: NCT07195279

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-07
• Study Completion Date: 2025-06-30

Brief Summary

Virtual reality (VR) is a high-end user-computer interface involving real-time stimulation and interaction of an embedded subject through visual and auditory sensorial channels, based on a synthetic environment in which the subject feels to be present. Over the past few decades, VR has been extensively used in psychological and neuroscientific research, as well as clinical applications, yielding promising results for diverse clinical conditions. Furthermore, VR has also been employed in the cardiovascular field across various settings, including cardiac rehabilitation, interventional cardiology, and cardiac surgery, to assess both physiological and psychological outcomes.

The benefits of using VR may stem from its ability to be customized, potentially enhancing the rehabilitation experience by offering cognitive, emotional, and physical advantages. It can improve patients' motivation and engagement, reduce anxiety. In general, in the context of cardiac rehabilitation, the impact of VR appears to be more closely linked to improvements in mental health, particularly in relation to psychological aspects such as mood enhancement, stress reduction, and increased emotional well-being. These benefits may be due to the immersive and engaging nature of VR, which can provide a sense of novelty, distraction from discomfort, and a greater feeling of control over the rehabilitation process. However, current evidence does not clearly demonstrate its superiority over conventional approaches in other important outcomes, including treatment adherence, patient satisfaction, and overall quality of life. The aim of this study was to test the efficacy of integrating the use of a VR system based on driving simulation in cardiac rehabilitation through a randomized controlled trial.

Detailed Description

The study is an RCT. The control group of this study performed a conventional cardiac rehabilitation protocol that consisted of a 1.5-hour group calisthenics sessions with a 10-minute break, held six times per week.

Patients were randomly allocated to the experimental virtual reality group and underwent the standard cardiac rehabilitation program, but some sessions were substituted by the virtual reality rehabilitation protocol. The VR intervention consisted of a simulated driving experience delivered over nine sessions, three times per week, each lasting 20 minutes, over a three-week period. Participants observed the virtual scenario through Meta Quest 2 head-mounted display. The 3D environment consisted of a realistic 3D model of a car's interior, simulating the driver's perspective (1:1 scale). The virtual cockpit incorporated an interactive steering wheel, controlled by participants from their perspective using Meta Controllers. This interaction, however, did not alter the vehicle's movement path. To optimize immersion, the Meta Controllers were rendered as hands, integrated with a 3D avatar model. The various scenarios the patient encountered corresponded to a progressively increasing level of difficulty as the rehabiltative sessions proceeded. Examples of challenging elements included narrow roads, urban traffic, tunnel driving, and high-speed roads. Each session lasted approximately 20 minutes, which was the time required to complete the driving route. However, the session might end earlier if the patient was unable to continue.

Conditions

Cardiac Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group (calisthenics sessions)

The control group of this study performed a conventional cardiac rehabilitation protocol that consisted of 1.5 hour group calisthenics sessions with a 10-minute break, held six times per week. This was accompanied by aerobic reconditioning exercises on a stationary bike or treadmill, depending on medical prescription and the patient's health status.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

Conventional cardiac rehabilitation protocol consisted of 1.5-hour group calisthenics sessions with a 10-minute break, held six times per week. This was accompanied by aerobic reconditioning exercises on a stationary bike or treadmill, depending on medical prescription and the patient's health status.

Experimental Group (VR experience)

The VR intervention consisted of a simulated driving experience delivered over nine sessions, three times per week, each lasting 20 minutes, over a three-week period. Patients were exposed to diverse driving scenarios, specifically: urban streets (featuring intersections, traffic lights, and pedestrians to simulate complex urban environments), ring roads (designed for practicing smooth and confident high-speed driving in dense traffic), and tunnels (sections aimed at gradually desensitizing users to claustrophobic responses during driving).

Group Type: EXPERIMENTAL

Experimental Group

Intervention Type: OTHER

The VR intervention consisted of a simulated driving experience delivered over nine sessions, three times per week, each lasting 20 minutes, over a three-week period. The virtual reality (VR) therapy employed a full immersion approach, delivering intense multisensory visual-auditory stimulation. Patients were exposed to diverse driving scenarios, specifically: urban streets (featuring intersections, traffic lights, and pedestrians to simulate complex urban environments), ring roads (designed for practicing smooth and confident high-speed driving in dense traffic), and tunnels (sections aimed at gradually desensitizing users to claustrophobic responses during driving).

Interventions

Experimental Group

The VR intervention consisted of a simulated driving experience delivered over nine sessions, three times per week, each lasting 20 minutes, over a three-week period. The virtual reality (VR) therapy employed a full immersion approach, delivering intense multisensory visual-auditory stimulation. Patients were exposed to diverse driving scenarios, specifically: urban streets (featuring intersections, traffic lights, and pedestrians to simulate complex urban environments), ring roads (designed for practicing smooth and confident high-speed driving in dense traffic), and tunnels (sections aimed at gradually desensitizing users to claustrophobic responses during driving).

Intervention Type: OTHER

Control Group

Conventional cardiac rehabilitation protocol consisted of 1.5-hour group calisthenics sessions with a 10-minute break, held six times per week. This was accompanied by aerobic reconditioning exercises on a stationary bike or treadmill, depending on medical prescription and the patient's health status.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of cardiovascular disease and need for intensive inpatient cardiac rehabilitation after cardiac surgery;
• Age over 18 years;
• Absence of comorbidities (cognitive deficits, psychiatric syndromes, visual sensitivity; physical conditions);
• Ability to understand and follow instructions provided by physiotherapists.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: collaborator

I.R.C.C.S. Fondazione Santa Lucia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Iosa, PhD, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

IRRCS Santa Lucia foundation

Locations

IRCCS Santa Lucia foundationa and Nomentana Hospital

Rome, Lazio, Italy

Countries

Italy

Other Identifiers

FSLVRHEART

Identifier Type: -

Identifier Source: org_study_id