An interventional study of IVR using the Morpheus Programme and Cardiac Rehabilitation control group in Cardiac Disease and Coronary Artery Bypass, sponsored by University of Malta. Enrolling by invitation at 1 site in Malta. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by University of Malta · Not applicable, Interventional, and Supportive care
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.
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.
2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.
This study's planned enrollment of 20 is below the median of 129 across 931 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →University of Malta is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
Procedure: IVR using the Morpheus Programme · Procedure: Cardiac Rehabilitation control group
no treatment using VR
Patients in the intervention group will receive 20 mins of immersive therapy during cardiac rehabilitation
Also known as: IVR
Cardiac rehabilitation but no IVR
Also known as: Exercise
6 minute walk test
Exercise Tolerance test
Time frame: Up to 6weeks
Hospital Anxiety and Depression Score
Measure for Anxiety and Depression
Time frame: Up to 6weeks
Plan to share: Yes — All information will be coded so each participant information is still anonymous
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: September 2024 to June 2025
Access criteria: The main researchers
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Jun 2025, 9 months after the start.
Of 263 non-industry interventional studies with no phase under Heart Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 9 months is below that.
Counting every sponsor, half of 336 studies reached it within 25 months; a quarter within 10 and three quarters within 52.
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