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

NCT07195279 | Completed

• 1 other identifier: FSLVRHEART
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Rehabilitation

Keywords

Virtual Reality; Rehabilitation; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Emotional benefit and distress reduction

  Hospital Anxiety and Depression Scale (HADS): A 14-item scale used to assess anxiety (7 items) and depression (7 items) levels related to illness. This scale is widely used to assess general mental health in hospitalized patients and chronically ill patients, allowing for symptom monitoring rather than making a specific diagnosis.

  This scale was administered at three time points: as baseline, before the beginning of intervention (Day 0), after the first session of treatment (Day 1) and after intervention completion (Day 21)

Secondary Outcomes (1)

• Upper limb Range of Motion

  This evaluation was made at two time points: after the first session of treatment (Day 1) and after intervention completion (Day 21)

Other Outcomes (1)

• Physiological exertion

  This evaluation was made on: Day 1, Day 3, Day 5, Day 9, Day 11, Day 13, Day 17, Day 19, Day 21

Study Arms (2)

Control Group (calisthenics sessions)

ACTIVE COMPARATOR

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.

Other: Control Group

Experimental Group (VR experience)

EXPERIMENTAL

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).

Other: Experimental Group

Interventions

Experimental Group 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).

Experimental Group (VR experience)

Control Group 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.

Control Group (calisthenics sessions)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

IRCCS Santa Lucia foundationa and Nomentana Hospital

Rome, Lazio, 00179, Italy

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Marco Iosa, PhD, Associate Professor

  IRRCS Santa Lucia foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 26, 2025
• Study Start: January 7, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)