Cardiac RehabilitationVIRTUAL RIABNCT07782749
Virtual Reality-Based Cardiac Rehabilitation in Patients Undergoing Cardiac Surgery
A study testing Virtual Reality in people with Cardiac Rehabilitation, run by Azienda Ospedaliero Universitaria di Sassari at 1 site in Italy.
Trial summary
This randomized controlled study will evaluate whether adding immersive virtual reality (VR) to cardiac rehabilitation can improve participation in rehabilitation and other health outcomes in patients who have recently undergone cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 30 Oct 2029
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 years;
- a clinically stable cardiovascular diagnosis.
Who cannot join
- conditions precluding physical exercise (e.g., bone fractures);
- conditions precluding the use of virtual reality (e.g., blindness and deafness);
- severe cognitive impairment, documented by a score of 0 to 4 on the Six-Item Screener;
- end-stage renal disease requiring dialysis;
- established advanced pulmonary disease;
- active malignancies;
- rheumatic diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Virtual Reality-Based Cardiac Rehabilitation in Patients Undergoing Cardiac Surgery
This randomized controlled study will evaluate whether adding immersive virtual reality (VR) to cardiac rehabilitation can improve participation in rehabilitation and other health outcomes in patients who have recently undergone cardiac surgery.
Cardiac rehabilitation is recommended after cardiac surgery to support recovery, improve physical function and quality of life, and reduce complications related to physical inactivity. However, some patients have difficulty completing the recommended rehabilitation program. Immersive VR may make exercise sessions more engaging and may help patients participate more consistently in their rehabilitation.
Read more
The study will enroll 46 adult patients who have undergone cardiac surgery within the previous 30 days, are clinically stable, and have an indication for cardiac rehabilitation. Participants will be randomly assigned in a 1:1 ratio to either an immersive VR group or a standard cardiac rehabilitation group.
Participants in both groups will complete the same supervised cardiac rehabilitation program, consisting of eight moderate-intensity exercise sessions performed on a treadmill or stationary bicycle. Each session will last approximately 30 minutes and will be performed twice a week for four weeks.
Participants assigned to the VR group will perform their rehabilitation sessions while wearing an immersive VR headset. The headset will provide natural audiovisual environments designed to create an immersive experience during exercise. A trained healthcare professional will assist participants with the technology and supervise them throughout each session. Participants will be able to stop the VR experience at any time if needed. Participants assigned to the control group will complete the same rehabilitation program without VR.
The primary outcome of the study is adherence to cardiac rehabilitation, measured as the percentage of scheduled rehabilitation sessions completed.
Secondary outcomes will assess changes from baseline to the end of the rehabilitation program in functional capacity using the 6-minute walk test, perceived exertion using the Borg scale, angina severity, cardiopulmonary exercise test parameters, heart rate, blood pressure, oxygen saturation, and health-related quality of life using the Kansas City Cardiomyopathy Questionnaire.
In the VR group, symptoms potentially related to VR exposure, known as cybersickness, will be assessed after each session using the Virtual Reality Symptom Questionnaire. At the end of the program, participants in the VR group will also be invited to take part in a semi-structured interview about their experience with virtual reality.
The study aims to determine whether immersive VR can be a useful approach to support participation in cardiac rehabilitation after cardiac surgery while also evaluating its effects on physical, clinical, and patient-reported outcomes.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Cardiac Rehabilitation, Cardiac Surgical Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called Immersive Virtual Reality, Virtual Reality-Assisted Cardiac Rehabilitation
Participants assigned to the intervention group will undergo cardiac rehabilitation while using immersive virtual reality. During each cardiac rehabilitation session, participants will wear an immersive virtual reality headset providing high-quality three-dimensional natural environments combined with natural high-definition stereo audio to enhance the immersive audiovisual experience. The virtual reality system may include the PICO 4® headset and the TREADMILL XR® application. Virtual reality will be provided throughout the 30-minute rehabilitation session under the supervision of a healthcare professional trained in virtual reality technology. Before the first session, participants will receive approximately 10 minutes of instruction and demonstration on the use of the virtual reality equipment. During the sessions, participants will be allowed to freely move their eyes and head, adjust the audio volume, and discontinue virtual reality at any time.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality arm | Experimental | We will use the latest generation of high-quality immersive virtual reality (VR) technology, featuring high integrated computing power, standalone operation, sophisticated software, and advanced optical components, thereby ensuring low latency and a wide field of view. The virtual scenarios selected will consist of natural environments, as interaction with such settings has been shown to provide a highly effective form of distraction. To further enhance the immersive experience, auditory sensory stimulation will also be incorporated.The selected audio content will consist of natural sounds and will be delivered directly through the headset in high-definition stereo to provide a fully immersive audiovisual experience. Devices that meet these requirements while offering a favorable cost-effectiveness profile include the PICO 4® headset and the TREADMILL XR® application. VR will be administered during the 30-minute cardiac rehabilitation (CR) session, under the supervision. Receives: Device: Virtual Reality |
| Standard Care arm | No intervention | Patients in the control group will undergo cardiac rehabilitation on a treadmill or stationary bicycle under the supervision of healthcare professionals, following the same guidelines as the intervention group in terms of the number of sessions, session duration, and exercise intensity, but without the use of virtual reality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Rehabilitation Adherence
Cardiac rehabilitation adherence will be measured as the percentage of scheduled rehabilitation sessions completed by each participant. Adherence will be calculated as the number of completed sessions divided by the total number of eight scheduled sessions, multiplied by 100. Higher percentages indicate greater adherence.
Measured: At completion of the 4-week cardiac rehabilitation program (after the eighth session)
Secondary outcomes (12)
Change from Baseline in Six-Minute Walk Test Distance at 4 Weeks
Functional capacity will be assessed using the Six-Minute Walk Test. Participants will be instructed to walk at their own pace for 6 minutes on a flat, hard surface and to cover the greatest possible distance. The outcome will be the total distance walked, expressed in meters. A greater distance indicates better functional capacity
Measured: Baseline and 4 weeks (after the eighth rehabilitation session)
Change from Baseline in Rating of Perceived Exertion at 4 Weeks
Perceived exertion will be assessed using the Borg Rating of Perceived Exertion Scale. The scale ranges from 6 to 20, where 6 corresponds to no exertion and 20 corresponds to maximal exertion. The Borg score will be recorded at baseline and after completion of the cardiac rehabilitation program.
Measured: Baseline and 4 weeks (after the eighth rehabilitation session).
Change from Baseline in Canadian Cardiovascular Society Angina Class at 4 Weeks
Angina severity will be assessed using the Canadian Cardiovascular Society classification of angina pectoris. The classification ranges from Class I, indicating no limitation of ordinary physical activity, to Class IV, indicating inability to perform physical activity without discomfort. Higher classes indicate greater functional limitation due to angina.
Measured: Baseline and 4 weeks (after the eighth rehabilitation session)
Change from Baseline in Metabolic Equivalents During Cardiopulmonary Exercise Testing at 4 Weeks
Exercise capacity will be assessed by cardiopulmonary exercise testing. Metabolic equivalents will be recorded during cardiopulmonary exercise testing at baseline and after completion of the cardiac rehabilitation program.
Measured: Baseline and 4 weeks (after the eighth rehabilitation session).
Change from Baseline in Exercise Workload Capacity During Cardiopulmonary Exercise Testing at 4 Weeks
Exercise workload capacity will be assessed during cardiopulmonary exercise testing at baseline and after completion of the cardiac rehabilitation program. The workload achieved during testing will be compared between the two assessment time points.
Measured: Baseline and 4 weeks (after the eighth rehabilitation session).
Occurrence of Exercise-Induced Arrhythmias During Cardiopulmonary Exercise Testing
The presence or absence of exercise-induced arrhythmias will be assessed during cardiopulmonary exercise testing at baseline and after completion of the cardiac rehabilitation program.
Measured: Baseline and 4 weeks (after the eighth rehabilitation session).
Change from Baseline in Heart Rate at 4 Weeks
Heart rate will be measured using a digital monitor at baseline and after completion of the cardiac rehabilitation program.
Measured: Baseline and 4 weeks (after the eighth rehabilitation session).
Change from Baseline in Peripheral Oxygen Saturation at 4 Weeks
Peripheral oxygen saturation will be measured using a digital monitor at baseline and after completion of the cardiac rehabilitation program and will be expressed as a percentage.
Measured: Baseline and 4 weeks (after the eighth rehabilitation session).
Change from Baseline in Systolic Blood Pressure at 4 Weeks
Systolic Blood Pressure will be measured using a digital monitor at baseline and after completion of the cardiac rehabilitation program.
Measured: Baseline and 4 weeks (after the eighth rehabilitation session).
Change from Baseline in Diastolic Blood Pressure at 4 Weeks
Diastolic Blood Pressure will be measured using a digital monitor at baseline and after completion of the cardiac rehabilitation program.
Measured: Change from Baseline in Diastolic Blood Pressure at 4 Weeks
Change from Baseline in Kansas City Cardiomyopathy Questionnaire Score at 4 Weeks
Health-related quality of life will be assessed using the 23-item Kansas City Cardiomyopathy Questionnaire. The questionnaire evaluates physical function, symptoms, social function, self-efficacy, and quality of life. Scores range from 0 to 100, with higher scores representing better health status.
Measured: Baseline and 4 weeks (after the eighth rehabilitation session).
Virtual Reality-Related Cybersickness
Cybersickness will be assessed in participants assigned to the virtual reality group using the 13-item Virtual Reality Symptom Questionnaire (VRSQ). The questionnaire comprises 8 non-ocular and 5 ocular symptoms. Each item is rated on a 7-point scale from 0 to 6, where 0 indicates no symptoms, 1-2 slight symptoms, 3-4 moderate symptoms, and 5-6 severe symptoms. Item scores will be summed to obtain a total VRSQ score ranging from 0 to 78, with higher scores indicating greater severity of virtual reality-related symptoms. Non-ocular and ocular subscores range from 0 to 48 and 0 to 30, respectively.
Measured: Immediately after each of the eight virtual reality sessions, over 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Micheluzzi, Azienda Ospedaliero Universitaria di Sassari
- Investigators
- Valentina Micheluzzi, PhD, Principal investigator, Azienda Ospedaliera Universitaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782749
- Sponsor's protocol ID
- AOSassari_VR
- Acronym
- VIRTUAL RIAB
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Weech S, Kenny S, Barnett-Cowan M. Presence and Cybersickness in Virtual Reality Are Negatively Related: A Review. Front Psychol. 2019 Feb 4;10:158. doi: 10.3389/fpsyg.2019.00158. eCollection 2019.
PubMed 30778320Sanches EE, Aupers E, Sakran N, Navalta J, Kostka T, Pouwels S. Barriers and Facilitators in Rehabilitation in Chronic Diseases and After Surgery: Is It a Matter of Adherence? Cureus. 2021 Dec 5;13(12):e20173. doi: 10.7759/cureus.20173. eCollection 2021 Dec.
PubMed 35003999Ruano-Ravina A, Pena-Gil C, Abu-Assi E, Raposeiras S, van 't Hof A, Meindersma E, Bossano Prescott EI, Gonzalez-Juanatey JR. Participation and adherence to cardiac rehabilitation programs. A systematic review. Int J Cardiol. 2016 Nov 15;223:436-443. doi: 10.1016/j.ijcard.2016.08.120. Epub 2016 Aug 13.
PubMed 27557484Resurreccion DM, Moreno-Peral P, Gomez-Herranz M, Rubio-Valera M, Pastor L, Caldas de Almeida JM, Motrico E. Factors associated with non-participation in and dropout from cardiac rehabilitation programmes: a systematic review of prospective cohort studies. Eur J Cardiovasc Nurs. 2019 Jan;18(1):38-47. doi: 10.1177/1474515118783157. Epub 2018 Jun 18.
PubMed 29909641Milojevic M, Freemantle N, Hayanga JWA, Kelly RF, Myers PO, Petersen RH, Opitz I, Sabik JF 3rd, Bakaeen FG. Harmonizing guidelines and other clinical practice documents: A joint comprehensive methodology manual by the American Association for Thoracic Surgery (AATS), European Association for Cardio-Thoracic Surgery (EACTS), European Society of Thoracic Surgeons (ESTS), and Society of Thoracic Surgeons (STS). J Thorac Cardiovasc Surg. 2025 Jan;169(1):170-185. doi: 10.1016/j.jtcvs.2024.07.048. Epub 2024 Oct 10. No abstract available.
PubMed 39387731Micheluzzi V, Casu G, Sanna GD, Canu A, Iovino P, Caggianelli G, Vellone E. Improving adherence to rehabilitation for heart failure patients through immersive virtual reality (VIRTUAL-HF): A protocol for a randomized controlled trial. Contemp Clin Trials. 2024 Mar;138:107463. doi: 10.1016/j.cct.2024.107463. Epub 2024 Jan 30.
PubMed 38302011Burrai F, De Marinis MG, Piredda M. Virtual Reality During Chemotherapy Infusion: An Innovative Intervention in Holistic Nursing Practice. Holist Nurs Pract. 2024 Jul-Aug 01;38(4):220-226. doi: 10.1097/HNP.0000000000000616. Epub 2024 Jun 19.
PubMed 37585475Ball L, Costantino F, Orefice G, Chandrapatham K, Pelosi P. Intraoperative mechanical ventilation: state of the art. Minerva Anestesiol. 2017 Oct;83(10):1075-1088. doi: 10.23736/S0375-9393.17.11970-X. Epub 2017 May 19.
PubMed 28528537Ames SL, Wolffsohn JS, McBrien NA. The development of a symptom questionnaire for assessing virtual reality viewing using a head-mounted display. Optom Vis Sci. 2005 Mar;82(3):168-76. doi: 10.1097/01.opx.0000156307.95086.6.
PubMed 15767873Ambrosetti M, Abreu A, Corra U, Davos CH, Hansen D, Frederix I, Iliou MC, Pedretti RFE, Schmid JP, Vigorito C, Voller H, Wilhelm M, Piepoli MF, Bjarnason-Wehrens B, Berger T, Cohen-Solal A, Cornelissen V, Dendale P, Doehner W, Gaita D, Gevaert AB, Kemps H, Kraenkel N, Laukkanen J, Mendes M, Niebauer J, Simonenko M, Zwisler AO. Secondary prevention through comprehensive cardiovascular rehabilitation: From knowledge to implementation. 2020 update. A position paper from the Secondary Prevention and Rehabilitation Section of the European Association of Preventive Cardiology. Eur J Prev Cardiol. 2021 May 14;28(5):460-495. doi: 10.1177/2047487320913379.
PubMed 33611446Almashrafi A, Elmontsri M, Aylin P. Systematic review of factors influencing length of stay in ICU after adult cardiac surgery. BMC Health Serv Res. 2016 Jul 29;16:318. doi: 10.1186/s12913-016-1591-3.
PubMed 27473872
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality-Based Cardiac Rehabilitation in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07782749
- Acronym / sponsor ID
- VIRTUAL RIAB / AOSassari_VR
- Conditions
- Cardiac Rehabilitation
- Keywords
- Virtual Reality, Cardiac Rehabilitation, Cardiac Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria di SassariUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 24 Aug 2026 (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.
This randomized controlled study will evaluate whether adding immersive virtual reality (VR) to cardiac rehabilitation can improve participation in rehabilitation and other health outcomes in patients who have recently undergone cardiac surgery.
Cardiac rehabilitation is recommended after cardiac surgery to support recovery, improve physical function and quality of life, and reduce complications related to physical inactivity. However, some patients have difficulty completing the recommended rehabilitation program. Immersive VR may make exercise sessions more engaging and may help patients participate more consistently in their rehabilitation.
The study will enroll 46 adult patients who have undergone cardiac surgery within the previous 30 days, are clinically stable, and have an indication for cardiac rehabilitation. Participants will be randomly assigned in a 1:1 ratio to either an immersive VR group or a standard cardiac rehabilitation group.
Participants in both groups will complete the same supervised cardiac rehabilitation program, consisting of eight moderate-intensity exercise sessions performed on a treadmill or stationary bicycle. Each session will last approximately 30 minutes and will be performed twice a week for four weeks.
Participants assigned to the VR group will perform their rehabilitation sessions while wearing an immersive VR headset. The headset will provide natural audiovisual environments designed to create an immersive experience during exercise. A trained healthcare professional will assist participants with the technology and supervise them throughout each session. Participants will be able to stop the VR experience at any time if needed. Participants assigned to the control group will complete the same rehabilitation program without VR.
The primary outcome of the study is adherence to cardiac rehabilitation, measured as the percentage of scheduled rehabilitation sessions completed.
Secondary outcomes will assess changes from baseline to the end of the rehabilitation program in functional capacity using the 6-minute walk test, perceived exertion using the Borg scale, angina severity, cardiopulmonary exercise test parameters, heart rate, blood pressure, oxygen saturation, and health-related quality of life using the Kansas City Cardiomyopathy Questionnaire.
In the VR group, symptoms potentially related to VR exposure, known as cybersickness, will be assessed after each session using the Virtual Reality Symptom Questionnaire. At the end of the program, participants in the VR group will also be invited to take part in a semi-structured interview about their experience with virtual reality.
The study aims to determine whether immersive VR can be a useful approach to support participation in cardiac rehabilitation after cardiac surgery while also evaluating its effects on physical, clinical, and patient-reported outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality arm | Experimental | Device: Virtual RealityWe will use the latest generation of high-quality immersive virtual reality (VR) technology, featuring high integrated computing power, standalone operation, sophisticated software, and advanced optical components, thereby ensuring low latency and a wide field of view. The virtual scenarios selected will consist of natural environments, as interaction with such settings has been shown to provide a highly effective form of distraction. To further enhance the immersive experience, auditory sensory stimulation will also be incorporated.The selected audio content will consist of natural sounds and will be delivered directly through the headset in high-definition stereo to provide a fully immersive audiovisual experience. Devices that meet these requirements while offering a favorable cost-effectiveness profile include the PICO 4® headset and the TREADMILL XR® application. VR will be administered during the 30-minute cardiac rehabilitation (CR) session, under the supervision. |
| Standard Care arm | No intervention | –Patients in the control group will undergo cardiac rehabilitation on a treadmill or stationary bicycle under the supervision of healthcare professionals, following the same guidelines as the intervention group in terms of the number of sessions, session duration, and exercise intensity, but without the use of virtual reality. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age over 18 years;
- a clinically stable cardiovascular diagnosis.
Key exclusion criteria (7 listed)
- conditions precluding physical exercise (e.g., bone fractures);
- conditions precluding the use of virtual reality (e.g., blindness and deafness);
- severe cognitive impairment, documented by a score of 0 to 4 on the Six-Item Screener;
- end-stage renal disease requiring dialysis;
- established advanced pulmonary disease;
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 |
|---|---|---|
| Virtual RealityAlso: Immersive Virtual Reality, Virtual Reality-Assisted Cardiac RehabilitationParticipants assigned to the intervention group will undergo cardiac rehabilitation while using immersive virtual reality. During each cardiac rehabilitation session, participants will wear an immersive virtual reality headset providing high-quality three-dimensional natural environments combined with natural high-definition stereo audio to enhance the immersive audiovisual experience. The virtual reality system may include the PICO 4® headset and the TREADMILL XR® application. Virtual reality will be provided throughout the 30-minute rehabilitation session under the supervision of a healthcare professional trained in virtual reality technology. Before the first session, participants will receive approximately 10 minutes of instruction and demonstration on the use of the virtual reality equipment. During the sessions, participants will be allowed to freely move their eyes and head, adjust the audio volume, and discontinue virtual reality at any time. | Device | Virtual Reality arm |
Primary outcome
Cardiac Rehabilitation Adherence
Time frame: At completion of the 4-week cardiac rehabilitation program (after the eighth session)
Cardiac rehabilitation adherence will be measured as the percentage of scheduled rehabilitation sessions completed by each participant. Adherence will be calculated as the number of completed sessions divided by the total number of eight scheduled sessions, multiplied by 100. Higher percentages indicate greater adherence.
12 secondary outcomes
Change from Baseline in Six-Minute Walk Test Distance at 4 Weeks
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session)
Change from Baseline in Rating of Perceived Exertion at 4 Weeks
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
Change from Baseline in Canadian Cardiovascular Society Angina Class at 4 Weeks
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session)
Change from Baseline in Metabolic Equivalents During Cardiopulmonary Exercise Testing at 4 Weeks
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
Change from Baseline in Exercise Workload Capacity During Cardiopulmonary Exercise Testing at 4 Weeks
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
Occurrence of Exercise-Induced Arrhythmias During Cardiopulmonary Exercise Testing
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
Change from Baseline in Heart Rate at 4 Weeks
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
Change from Baseline in Peripheral Oxygen Saturation at 4 Weeks
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
Change from Baseline in Systolic Blood Pressure at 4 Weeks
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
Change from Baseline in Diastolic Blood Pressure at 4 Weeks
Time frame: Change from Baseline in Diastolic Blood Pressure at 4 Weeks
Change from Baseline in Kansas City Cardiomyopathy Questionnaire Score at 4 Weeks
Time frame: Baseline and 4 weeks (after the eighth rehabilitation session).
Virtual Reality-Related Cybersickness
Time frame: Immediately after each of the eight virtual reality sessions, over 4 weeks.
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 25 Aug 2026.
- Background: PubMed 30778320Weech S, Kenny S, Barnett-Cowan M. Presence and Cybersickness in Virtual Reality Are Negatively Related: A Review. Front Psychol. 2019 Feb 4;10:158. doi: 10.3389/fpsyg.2019.00158. eCollection 2019.
- Background: PubMed 35003999Sanches EE, Aupers E, Sakran N, Navalta J, Kostka T, Pouwels S. Barriers and Facilitators in Rehabilitation in Chronic Diseases and After Surgery: Is It a Matter of Adherence? Cureus. 2021 Dec 5;13(12):e20173. doi: 10.7759/cureus.20173. eCollection 2021 Dec.
- Background: PubMed 27557484Ruano-Ravina A, Pena-Gil C, Abu-Assi E, Raposeiras S, van 't Hof A, Meindersma E, Bossano Prescott EI, Gonzalez-Juanatey JR. Participation and adherence to cardiac rehabilitation programs. A systematic review. Int J Cardiol. 2016 Nov 15;223:436-443. doi: 10.1016/j.ijcard.2016.08.120. Epub 2016 Aug 13.
- Background: PubMed 29909641Resurreccion DM, Moreno-Peral P, Gomez-Herranz M, Rubio-Valera M, Pastor L, Caldas de Almeida JM, Motrico E. Factors associated with non-participation in and dropout from cardiac rehabilitation programmes: a systematic review of prospective cohort studies. Eur J Cardiovasc Nurs. 2019 Jan;18(1):38-47. doi: 10.1177/1474515118783157. Epub 2018 Jun 18.
- Background: PubMed 39387731Milojevic M, Freemantle N, Hayanga JWA, Kelly RF, Myers PO, Petersen RH, Opitz I, Sabik JF 3rd, Bakaeen FG. Harmonizing guidelines and other clinical practice documents: A joint comprehensive methodology manual by the American Association for Thoracic Surgery (AATS), European Association for Cardio-Thoracic Surgery (EACTS), European Society of Thoracic Surgeons (ESTS), and Society of Thoracic Surgeons (STS). J Thorac Cardiovasc Surg. 2025 Jan;169(1):170-185. doi: 10.1016/j.jtcvs.2024.07.048. Epub 2024 Oct 10. No abstract available.
- Background: PubMed 38302011Micheluzzi V, Casu G, Sanna GD, Canu A, Iovino P, Caggianelli G, Vellone E. Improving adherence to rehabilitation for heart failure patients through immersive virtual reality (VIRTUAL-HF): A protocol for a randomized controlled trial. Contemp Clin Trials. 2024 Mar;138:107463. doi: 10.1016/j.cct.2024.107463. Epub 2024 Jan 30.
- Background: PubMed 37585475Burrai F, De Marinis MG, Piredda M. Virtual Reality During Chemotherapy Infusion: An Innovative Intervention in Holistic Nursing Practice. Holist Nurs Pract. 2024 Jul-Aug 01;38(4):220-226. doi: 10.1097/HNP.0000000000000616. Epub 2024 Jun 19.
- Background: PubMed 28528537Ball L, Costantino F, Orefice G, Chandrapatham K, Pelosi P. Intraoperative mechanical ventilation: state of the art. Minerva Anestesiol. 2017 Oct;83(10):1075-1088. doi: 10.23736/S0375-9393.17.11970-X. Epub 2017 May 19.
- Background: PubMed 15767873Ames SL, Wolffsohn JS, McBrien NA. The development of a symptom questionnaire for assessing virtual reality viewing using a head-mounted display. Optom Vis Sci. 2005 Mar;82(3):168-76. doi: 10.1097/01.opx.0000156307.95086.6.
- Background: PubMed 33611446Ambrosetti M, Abreu A, Corra U, Davos CH, Hansen D, Frederix I, Iliou MC, Pedretti RFE, Schmid JP, Vigorito C, Voller H, Wilhelm M, Piepoli MF, Bjarnason-Wehrens B, Berger T, Cohen-Solal A, Cornelissen V, Dendale P, Doehner W, Gaita D, Gevaert AB, Kemps H, Kraenkel N, Laukkanen J, Mendes M, Niebauer J, Simonenko M, Zwisler AO. Secondary prevention through comprehensive cardiovascular rehabilitation: From knowledge to implementation. 2020 update. A position paper from the Secondary Prevention and Rehabilitation Section of the European Association of Preventive Cardiology. Eur J Prev Cardiol. 2021 May 14;28(5):460-495. doi: 10.1177/2047487320913379.
- Background: PubMed 27473872Almashrafi A, Elmontsri M, Aylin P. Systematic review of factors influencing length of stay in ICU after adult cardiac surgery. BMC Health Serv Res. 2016 Jul 29;16:318. doi: 10.1186/s12913-016-1591-3.
- Individual participant dataSharing planned: Undecided
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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.
Valentina Micheluzzi, PhD principal investigator
Azienda Ospedaliera Universitaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Cardiac Rehabilitation, run by Azienda Ospedaliero Universitaria di Sassari 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?
The sponsor lists 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 25 Aug 2026. 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?
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?
Contact Valentina Micheluzzi, PhD (+ 39 3401753630, valentina.micheluzzi@aousassari.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Rehabilitation Adherence (time frame: At completion of the 4-week cardiac rehabilitation program (after the eighth session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07782749, which also lists 11 linked publications.
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 25 Aug 2026.