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Enrolling by invitationNCT06898827Updated Mar 27, 2025

Distraction Therapy Using Virtual Reality in Cardiac Rehabilitation

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

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 4 months after the study started (first participant enrolled Sep 2024, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cardiac Disease
  • Coronary Artery Bypass

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Keywords

  • Cardiac Rehabilitation
  • Virtual Reality
  • Rehabilitation
03

In context

Heart Diseases

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 →

Lead sponsor

University of Malta is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients who are suffering from any cardiac condition
  • Patients who have had a cardiac event
  • Patients referred for cardiac rehabilitation.

Exclusion criteria

Exclusion Criteria:

  • Patients with Atrial Fibrillation
  • Patients with an implantable cardioverter defibrillator
  • Patients with a pacemaker and
  • Patients who suffer from Vertigo
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
20 participants (estimated)

Study arms

  • 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.

    Procedure: IVR using the Morpheus Programme · Procedure: Cardiac Rehabilitation control group

  • No intervention
    Control

    no treatment using VR

Interventions

  • ProcedureIVR using the Morpheus Programme

    Patients in the intervention group will receive 20 mins of immersive therapy during cardiac rehabilitation

    Also known as: IVR

  • ProcedureCardiac Rehabilitation control group

    Cardiac rehabilitation but no IVR

    Also known as: Exercise

06

What researchers measure

Primary outcomes

  1. 6 minute walk test

    Exercise Tolerance test

    Time frame: Up to 6weeks

  2. Hospital Anxiety and Depression Score

    Measure for Anxiety and Depression

    Time frame: Up to 6weeks

07

Study locations

1 site
  • Department of Physiotherapy Faculty of Health Sciences
    Imsida, MSD2080, Malta
08

References and documents

Individual participant data

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2025
First posted
Mar 27, 2025
StartActual
Sep 1, 2024
Primary completionEst.
Jun 30, 2025
CompletionEst.
Jun 30, 2025
Last update
Mar 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06898827
Lead sponsor
University of Malta
Responsible party
Anabel Sciriha (Principal Investigator, University of Malta) — Principal investigator
First posted
Mar 27, 2025
Start date
Sep 1, 2024
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Mar 27, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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