Cardiac RehabilitationVRHEARTNCT07195279
Psychometric and Physiological Assessment of the Effects of Vir-tual Reality in Cardiovascular Rehabilitation
A study testing Experimental Group in people with Cardiac Rehabilitation, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Santa Lucia foundationa and Nomentana Hospital
Rome, Lazio, 00179
About this study
Official title: Psychometric and Physiological Assessment of the Effects of Vir-tual Reality in Cardiovascular Rehabilitation: a Randomized Con-trolled Trial
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.
Read the 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
- Being tested
- Experimental Group, Control Group
- Keywords
- Virtual Reality, Rehabilitation, Cardiac Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
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).
Control GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Assessment of changes in upper limb range of motion: shoulder flexion/extension, elbow flexion/extension.
Measured: This evaluation was made at two time points: after the first session of treatment (Day 1) and after intervention completion (Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start7 Jan 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Sponsor
- Investigators
- Marco Iosa, PhD, Associate Professor, Principal investigator, IRRCS Santa Lucia foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195279
- Sponsor's protocol ID
- FSLVRHEART
- Acronym
- VRHEART
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available under request to corresponding Author after publications
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric and Physiological Assessment of the Effects of Vir-tual Reality in Cardiovascular Rehabilitation: a Randomized Con-trolled Trial
- ClinicalTrials.gov ID
- NCT07195279
- Acronym / sponsor ID
- VRHEART / FSLVRHEART
- Conditions
- Cardiac Rehabilitation
- Keywords
- Virtual Reality, Rehabilitation, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Control Group (calisthenics sessions) | Active comparator | Other: Control GroupThe 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. |
| Experimental Group (VR experience) | Experimental | Other: Experimental GroupThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupThe 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). | Other | Experimental Group (VR experience) |
| Control GroupConventional 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. | Other | Control Group (calisthenics sessions) |
Primary outcome
Emotional benefit and distress reduction
Time frame: 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)
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.
1 secondary outcome
Upper limb Range of Motion
Time frame: This evaluation was made at two time points: after the first session of treatment (Day 1) and after intervention completion (Day 21)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No. Data will be available under request to corresponding Author after publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Iosa, PhD, Associate Professor principal investigator
IRRCS Santa Lucia foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Cardiac Rehabilitation, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional benefit and distress reduction (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.