Distraction Therapy Using Virtual Reality in Cardiac Rehabilitation

NCT06898827 | Enrolling By Invitation

• 1 other identifier: Cardiac Rehab & VR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Disease; Coronary Artery Bypass

Keywords

Cardiac Rehabilitation; Virtual Reality; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 6 minute walk test

  Exercise Tolerance test

  Up to 6weeks

• Hospital Anxiety and Depression Score

  Measure for Anxiety and Depression

  Up to 6weeks

Study Arms (2)

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

Control

NO INTERVENTION

no treatment using VR

Interventions

IVR using the Morpheus Programme PROCEDURE

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

Also known as: IVR

Experimental

Cardiac Rehabilitation control group PROCEDURE

Cardiac rehabilitation but no IVR

Also known as: Exercise

Experimental

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Malta: lead

Study Sites (1)

Department of Physiotherapy Faculty of Health Sciences

Msida, MSD2080, Malta

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dr Anabel Sciriha, PhD

  University of Malta

  PRINCIPAL INVESTIGATOR

• Dr Stephen Lungaro-Mifsud, PhD

  University of Malta

  PRINCIPAL INVESTIGATOR

• Dr Tonio Agius, PhD

  University of Malta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators will be blinded to all participants and their allocated group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: March 27, 2025
• Study Start: September 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: September 2024 to June 2025
• Access Criteria: The main researchers

Locations

MA (1)