Cardiac DiseaseNCT06898827
Distraction Therapy Using Virtual Reality in Cardiac Rehabilitation
A study testing IVR using the Morpheus Programme in people with Cardiac Disease and Coronary Artery Bypass, run by University of Malta at 1 site in Malta.
Trial summary
The European Society of Cardiology has been putting forward the need for new adjuncts or models that optimise outcomes from CR programmes. Immersive virtual reality (IVR) is one of the newest technologies whose input in CR is currently being investigated. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiac Disease, Coronary Artery Bypass
- What is being tested?
- IVR using the Morpheus Programme
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMalta
- Study dates
- 1 Sep 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who are suffering from any cardiac condition
- Patients who have had a cardiac event
- Patients referred for cardiac rehabilitation.
Who cannot join
- Patients with Atrial Fibrillation
- Patients with an implantable cardioverter defibrillator
- Patients with a pacemaker and
- Patients who suffer from Vertigo
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malta1 site
Department of Physiotherapy Faculty of Health Sciences
Msida, MSD2080
About this study
Official title: Distraction Therapy Using Virtual Reality in Patients Undergoing Cardiac Rehabilitation: Effects on Cardiac Efficiency, Anxiety and Exercise Tolerance
The European Society of Cardiology has been putting forward the need for new adjuncts or models that optimise outcomes from CR programmes. Immersive virtual reality (IVR) is one of the newest technologies whose input in CR is currently being investigated. It is a technology which helps simulate the real environment through a virtual one, allowing for interaction with the environment and to carry out exercise with variability, where intensity, repetition and feedback are key elements. It is reported that immersion in VR environments diverts the attention of the patient from unpleasant bodily sensations, thus delaying the onset of boredom and fatigue. This is reported to possibly incite higher participation. In addition, VR has some noticeable indirect benefits for postcardiac event patients. It is reported that when using head-mounted devices during stationary cycling, a reduction in sympathetic tone and thus increase blood flow to the muscles prolonging the exercise duration and enhancing fatigue resistance will result. The use of distraction therapy through VR, one which isolates the patients from the medical context and puts all the attention on the virtual experience, makes the patient be distracted from the unpleasant stimuli of the surrounding environment. Distraction therapy through VR is reported to provide positive emotions, reduce anxiety and lead to an underestimation of the treatment duration.
Read the detailed description
Cardiovascular disease is a leading cause of death and morbidity worldwide, with the WHO reporting 17.9 million of all global deaths in 2019 attributed to cardiovascular disease, with 7.4 million deaths attributed to coronary heart disease. In Europe, CVDs are estimated to cause close to 4 million deaths annually, generating a cost of 196 billion Euros/year. Cardiac rehabilitation, an intervention offered to the majority of patients who would have experience any cardiac event, includes several components delivered by a multi-disciplinary team. The components include health education, advice on cardiovascular risk reduction, physical activity, and stress management. Evidence that cardiac rehabilitation reduces mortality, morbidity, unplanned hospital admissions in addition to improvements in exercise capacity, quality of life and psychological well-being is increasing, and it is now recommended in international guidelines, ones which include the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation, The Canadian Association of Cardiac Rehabilitation, The European Association of Cardiovascular Prevention and Rehabilitation, The Australian Cardiovascular Health and Rehabilitation Association and The World Health Organization Expert Committee on Rehabilitation after Cardiovascular Diseases. Despite evidence proving all the benefits mentioned above, participation in such interventions is still considered low, and those that complete the programme fail to adhere to exercise after.
The main factors attributing to lack of completion or adherence to CR are depression and anxiety, factors which have been reported to have detrimental effects on self-management behaviours in patients after cardiac surgery. Anxiety has been reported to be independently associated with an increased mortality rate in patients diagnosed with coronary artery disease, particularly in the presence of comorbid depression. Together with this, baseline depression has been associated with the development of a sedentary lifestyle in the long term, as well as with adverse cardiovascular outcomes and increased health care costs. It was reported that depression and anxiety are likely to persist despite cardiac treatment and rehabilitation and if these are not addressed, the positive effects of expensive specialist cardiac procedures and rehabilitation can be diminished. Therefore, the need to determine efficient methods for managing depression and anxiety and improve the outcomes of CR is required.
The European Society of Cardiology has been putting forward the need for new adjuncts or models that optimise outcomes from CR programmes. Immersive virtual reality (IVR) is one of the newest technologies whose input in CR is currently being investigated. It is a technology which helps simulate the real environment through a virtual one, allowing for interaction with the environment and to carry out exercise with variability, where intensity, repetition and feedback are key elements. Immersion in VR environments diverts the attention of the patient from unpleasant bodily sensations, thus delaying the onset of boredom and fatigue. This is reported to possibly incite higher participation. In addition, VR has some noticeable indirect benefits for postcardiac event patients. When using head-mounted devices during stationary cycling, a reduction in sympathetic tone and thus increase blood flow to the muscles prolonging the exercise duration and enhancing fatigue resistance will result. The use of distraction therapy through VR, one which isolates the patients from the medical context and puts all the attention on the virtual experience, makes the patient be distracted from the unpleasant stimuli of the surrounding environment. Distraction therapy through VR is reported to provide positive emotions, reduce anxiety and lead to an underestimation of the treatment duration.
However, although IVR has captured the attention of professionals working in the field of CR, studies in this field are still limited and published protocols are very heterogeneous. IVR has been reported to increase functional capacity, motivation and adherence of patients undergoing CR programmes, however, there is no consensus regarding the outcome measures to be studied, the number of sessions, the protocol to be followed or the technology to be used, since there is great heterogeneity in the scientific literature. Therefore, despite the potential usefulness of the use of VR, there is a need to determine the main short- and medium-term outcome measures in CR programmes.
This research shall therefore investigate whether the inclusion of IVR in patients undergoing phase 3 of CR helps improve anxiety and depression scores, which in turn will increase exercise tolerance and cardiac efficiency when compared to patients who do not have access to this modality.
- Conditions
- Cardiac Disease, Coronary Artery Bypass
- Being tested
- IVR using the Morpheus Programme, Cardiac Rehabilitation control group
- Keywords
- Cardiac Rehabilitation, Virtual Reality, Rehabilitation
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVR using the Morpheus ProgrammeProcedure or surgery
Also called IVR
Patients in the intervention group will receive 20 mins of immersive therapy during cardiac rehabilitation
Cardiac Rehabilitation control groupProcedure or surgery
Also called Exercise
Cardiac rehabilitation but no IVR
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The intervention group who shall be subject to 20 minutes of IVR using the MORPHEUS programme, software developed by the Faculty of Information and Technology, when carrying out cycle ergometry during the 6 - week, bi-weekly CR programme. These patients shall carry out 10 minutes of warm up by cycling without IVR, followed by 20 minutes of cycling while wearing the headset with IVR input, followed by another 10 minutes of cool down without IVR input. The duration of 20 minutes input time was based on recommendations set by the Department of Business, Energy and Industrial Strategy, UK (2020) to prevent motion sickness. Receives: Procedure: IVR using the Morpheus Programme; Procedure: Cardiac Rehabilitation control group |
| Control | No intervention | no treatment using VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
Exercise Tolerance test
Measured: Up to 6weeks
Hospital Anxiety and Depression Score
Measure for Anxiety and Depression
Measured: Up to 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Sep 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A minimum of 20 patients undergoing phase 3 of CR shall be recruited in this study. All patients who are suffering from any cardiac condition or have had a cardiac event and are referred for cardiac rehabilitation are eligible to participate. Patients with Atrial Fibrillation, those with an implantable cardioverter defibrillator or a pacemaker and any patients known to suffer from Vertigo shall be excluded from the study. Those patients showing an interest in participating shall be offered information about what the study entails by the intermediary, this being the cardiac rehabilitation nurse. Upon consenting, general baseline demographic data including age, weight, height, body mass index (BMI), gender and drug history will be collected. The participants shall then be randomly assigned into two groups being: the control group who shall receive the usual CR programme without the addition of VR, and the intervention group who shall be subject to 20 minutes of IVR2
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabel Sciriha, University of Malta
- Investigators
- Dr Anabel Sciriha, PhD, Principal investigator, University of MaltaDr Stephen Lungaro-Mifsud, PhD, Principal investigator, University of MaltaDr Tonio Agius, PhD, Principal investigator, University of Malta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898827
- Sponsor's protocol ID
- Cardiac Rehab & VR
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All information will be coded so each participant information is still anonymous
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distraction Therapy Using Virtual Reality in Patients Undergoing Cardiac Rehabilitation: Effects on Cardiac Efficiency, Anxiety and Exercise Tolerance
- ClinicalTrials.gov ID
- NCT06898827
- Acronym / sponsor ID
- Cardiac Rehab & VR
- Conditions
- Cardiac Disease, Coronary Artery Bypass
- Keywords
- Cardiac Rehabilitation, Virtual Reality, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MaltaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Mar 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.
The European Society of Cardiology has been putting forward the need for new adjuncts or models that optimise outcomes from CR programmes. Immersive virtual reality (IVR) is one of the newest technologies whose input in CR is currently being investigated. It is a technology which helps simulate the real environment through a virtual one, allowing for interaction with the environment and to carry out exercise with variability, where intensity, repetition and feedback are key elements. It is reported that immersion in VR environments diverts the attention of the patient from unpleasant bodily sensations, thus delaying the onset of boredom and fatigue. This is reported to possibly incite higher participation. In addition, VR has some noticeable indirect benefits for postcardiac event patients. It is reported that when using head-mounted devices during stationary cycling, a reduction in sympathetic tone and thus increase blood flow to the muscles prolonging the exercise duration and enhancing fatigue resistance will result. The use of distraction therapy through VR, one which isolates the patients from the medical context and puts all the attention on the virtual experience, makes the patient be distracted from the unpleasant stimuli of the surrounding environment. Distraction therapy through VR is reported to provide positive emotions, reduce anxiety and lead to an underestimation of the treatment duration.
Detailed description
Cardiovascular disease is a leading cause of death and morbidity worldwide, with the WHO reporting 17.9 million of all global deaths in 2019 attributed to cardiovascular disease, with 7.4 million deaths attributed to coronary heart disease. In Europe, CVDs are estimated to cause close to 4 million deaths annually, generating a cost of 196 billion Euros/year. Cardiac rehabilitation, an intervention offered to the majority of patients who would have experience any cardiac event, includes several components delivered by a multi-disciplinary team. The components include health education, advice on cardiovascular risk reduction, physical activity, and stress management. Evidence that cardiac rehabilitation reduces mortality, morbidity, unplanned hospital admissions in addition to improvements in exercise capacity, quality of life and psychological well-being is increasing, and it is now recommended in international guidelines, ones which include the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation, The Canadian Association of Cardiac Rehabilitation, The European Association of Cardiovascular Prevention and Rehabilitation, The Australian Cardiovascular Health and Rehabilitation Association and The World Health Organization Expert Committee on Rehabilitation after Cardiovascular Diseases. Despite evidence proving all the benefits mentioned above, participation in such interventions is still considered low, and those that complete the programme fail to adhere to exercise after.
The main factors attributing to lack of completion or adherence to CR are depression and anxiety, factors which have been reported to have detrimental effects on self-management behaviours in patients after cardiac surgery. Anxiety has been reported to be independently associated with an increased mortality rate in patients diagnosed with coronary artery disease, particularly in the presence of comorbid depression. Together with this, baseline depression has been associated with the development of a sedentary lifestyle in the long term, as well as with adverse cardiovascular outcomes and increased health care costs. It was reported that depression and anxiety are likely to persist despite cardiac treatment and rehabilitation and if these are not addressed, the positive effects of expensive specialist cardiac procedures and rehabilitation can be diminished. Therefore, the need to determine efficient methods for managing depression and anxiety and improve the outcomes of CR is required.
The European Society of Cardiology has been putting forward the need for new adjuncts or models that optimise outcomes from CR programmes. Immersive virtual reality (IVR) is one of the newest technologies whose input in CR is currently being investigated. It is a technology which helps simulate the real environment through a virtual one, allowing for interaction with the environment and to carry out exercise with variability, where intensity, repetition and feedback are key elements. Immersion in VR environments diverts the attention of the patient from unpleasant bodily sensations, thus delaying the onset of boredom and fatigue. This is reported to possibly incite higher participation. In addition, VR has some noticeable indirect benefits for postcardiac event patients. When using head-mounted devices during stationary cycling, a reduction in sympathetic tone and thus increase blood flow to the muscles prolonging the exercise duration and enhancing fatigue resistance will result. The use of distraction therapy through VR, one which isolates the patients from the medical context and puts all the attention on the virtual experience, makes the patient be distracted from the unpleasant stimuli of the surrounding environment. Distraction therapy through VR is reported to provide positive emotions, reduce anxiety and lead to an underestimation of the treatment duration.
However, although IVR has captured the attention of professionals working in the field of CR, studies in this field are still limited and published protocols are very heterogeneous. IVR has been reported to increase functional capacity, motivation and adherence of patients undergoing CR programmes, however, there is no consensus regarding the outcome measures to be studied, the number of sessions, the protocol to be followed or the technology to be used, since there is great heterogeneity in the scientific literature. Therefore, despite the potential usefulness of the use of VR, there is a need to determine the main short- and medium-term outcome measures in CR programmes.
This research shall therefore investigate whether the inclusion of IVR in patients undergoing phase 3 of CR helps improve anxiety and depression scores, which in turn will increase exercise tolerance and cardiac efficiency when compared to patients who do not have access to this modality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A minimum of 20 patients undergoing phase 3 of CR shall be recruited in this study. All patients who are suffering from any cardiac condition or have had a cardiac event and are referred for cardiac rehabilitation are eligible to participate. Patients with Atrial Fibrillation, those with an implantable cardioverter defibrillator or a pacemaker and any patients known to suffer from Vertigo shall be excluded from the study. Those patients showing an interest in participating shall be offered information about what the study entails by the intermediary, this being the cardiac rehabilitation nurse. Upon consenting, general baseline demographic data including age, weight, height, body mass index (BMI), gender and drug history will be collected. The participants shall then be randomly assigned into two groups being: the control group who shall receive the usual CR programme without the addition of VR, and the intervention group who shall be subject to 20 minutes of IVR2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: IVR using the Morpheus Programme, Procedure: Cardiac Rehabilitation control groupThe intervention group who shall be subject to 20 minutes of IVR using the MORPHEUS programme, software developed by the Faculty of Information and Technology, when carrying out cycle ergometry during the 6 - week, bi-weekly CR programme. These patients shall carry out 10 minutes of warm up by cycling without IVR, followed by 20 minutes of cycling while wearing the headset with IVR input, followed by another 10 minutes of cool down without IVR input. The duration of 20 minutes input time was based on recommendations set by the Department of Business, Energy and Industrial Strategy, UK (2020) to prevent motion sickness. |
| Control | No intervention | –no treatment using VR |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients who are suffering from any cardiac condition
- Patients who have had a cardiac event
- Patients referred for cardiac rehabilitation.
Key exclusion criteria (4 listed)
- Patients with Atrial Fibrillation
- Patients with an implantable cardioverter defibrillator
- Patients with a pacemaker and
- Patients who suffer from Vertigo
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 |
|---|---|---|
| IVR using the Morpheus ProgrammeAlso: IVRPatients in the intervention group will receive 20 mins of immersive therapy during cardiac rehabilitation | Procedure or surgery | Experimental |
| Cardiac Rehabilitation control groupAlso: ExerciseCardiac rehabilitation but no IVR | Procedure or surgery | Experimental |
Primary outcome
6 minute walk test
Time frame: Up to 6weeks
Exercise Tolerance test
Hospital Anxiety and Depression Score
Time frame: Up to 6weeks
Measure for Anxiety and Depression
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Yes. All information will be coded so each participant information is still anonymous
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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.
Dr Anabel Sciriha, PhD principal investigator
University of Malta
Dr Stephen Lungaro-Mifsud, PhD principal investigator
University of Malta
Dr Tonio Agius, PhD principal investigator
University of Malta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVR using the Morpheus Programme in people with Cardiac Disease and Coronary Artery Bypass, run by University of Malta at 1 site in Malta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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: enrolling by invitation, as of the sponsor's last update on 27 Mar 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 Malta. 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?
This study is still under way. Results are not available in the source record yet.
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?
6 minute walk test (time frame: Up to 6weeks). The study lists 2 primary outcomes in all. 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 27 Mar 2025.