Cardiovascular DiseasesNCT06896318
Virtual Reality-Supported Cardiac Rehabilitation: Psychological, Functional, and Physiological Perspectives
A study testing Virtual Reality Therapy and Cardiac rehabilitation in people with Cardiovascular Diseases and Coronary Arterial Disease (CAD), run by Wroclaw University of Health and Sport Sciences at 2 sites in Poland.
Trial summary
The study aims to evaluate the effectiveness of virtual reality-assisted cardiac rehabilitation compared to conventional cardiac rehabilitation in improving psychological outcomes-depression, stress, anxiety, and kinesiophobia-along with physiological parameters, functional status, physical activity levels, and… Read more about this study
- Who is it for?
- Ages 60 months to 85 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Arterial Disease (CAD), Myocardial Disease
- What is being tested?
- Virtual Reality Therapy and Cardiac rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Apr 2025to 30 Jun 2026
- 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 60 months to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cardiovascular diseases (atherosclerosis, hypertension, coronary artery disease, ischemic heart disease, peripheral artery disease, rheumatic heart disease, deep vein thrombosis, pulmonary embolism, and post-myocardial infraction)
- the second stage of cardiac rehabilitation conducted in outpatient settings
Who cannot join
- Severe psychiatric disorders (e.g., psychotic symptoms, bipolar disorder)
- initiation of psychiatric treatment or individual psychological therapy during the study period
- current use of antidepressant medications
- cognitive impairments that hinder questionnaire completion, consciousness disorders
- sensory impairments (e.g., severe visual or auditory deficits) that limit interaction with virtual reality.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Cardiac Rehabilita6on Department of the Provincial Specialist Hospital of the Blessed Virgin Mary in Czestochowa, Poland
Częstochowa, Upper Silesia, 42-200
Jan Dlugosz University in Czestochowa
Częstochowa, Upper Silesia, 42-200
About this study
The study aims to evaluate the effectiveness of virtual reality-assisted cardiac rehabilitation compared to conventional cardiac rehabilitation in improving psychological outcomes-depression, stress, anxiety, and kinesiophobia-along with physiological parameters, functional status, physical activity levels, and quality of life in cardiac patients.
Read the detailed description
This single-blind randomized controlled trial will include 60 participants aged 60 years and older undergoing Phase II CR at the Provincial Specialist Hospital of the Blessed Virgin Mary in Częstochowa, Poland. Participants will be randomly assigned to one of two groups: a conventional CR program or a VR-CR group. Both groups will complete a three-week hospital-based CR program involving structured group exercises, interval cycling, and relaxation sessions. The experimental group will additionally receive eight sessions of immersive VR therapy using the VRTierOne device, consisting of 20-minute sessions twice weekly. These sessions employ interactive and calming virtual environments to promote relaxation and psychological engagement. Outcome measures will be evaluated at baseline (week 0), post-intervention (week 3), and follow-up (week 7). Assessments will include Patient-Reported Outcome Measures for stress, depression, kinesiophobia, and quality of life, physiological metrics (heart rate, blood pressure, metabolic equivalents), HRV, functional capacity (6MWT), and physical activity levels measured using the pedometers.
- Conditions
- Cardiovascular Diseases, Coronary Arterial Disease (CAD), Myocardial Disease, Heart Disease
- Being tested
- Virtual Reality Therapy, Cardiac rehabilitation
- Keywords
- virtual reality, relaxation, cardiac rehabilitation, kinesiophobia, stress, depression, new technologies, heart disease
- Medical subject headings
- Cardiovascular Diseases, Cardiomyopathies, Heart Diseases, Kinesiophobia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TherapyDevice
8 sessions of VR therapy (each of them 20 minutes long). As a virtual reality source, VR TierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach.The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation.
Cardiac rehabilitationBehavioural
A three-week, hospital-based cardiac rehabilitation program for all participants, incorporating structured group exercises and activities. The conventional cardiac rehabilitation program includes morning warm-up exercises, afternoon group sessions, interval training on stationary bikes, and relaxation activities. Morning sessions consist of 20 minutes of standing cardiovascular exercises accompanied by music, while afternoon sessions include 45 minutes of seated activities, divided into cardiovascular, equipment-based, and breathing exercises.
| Study group | Role | What they receive |
|---|---|---|
| VR Group | Experimental | Cardiac rehabilitation supplemented by VR therapy Receives: Device: Virtual Reality Therapy; Behavioral: Cardiac rehabilitation |
| Control Group | Active comparator | Conventional cardiac rehabilitation Receives: Behavioral: Cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Tampa Scale for Kinesiophobia (TSK) at 3 and 7 weeks
TSK consists of 17 items designed to assess fear of movement and re-injury (kinesiophobia) in individuals experiencing pain or undergoing rehabilitation. Each item presents a statement regarding beliefs about movement and pain, with respondents indicating their level of agreement on a scale from 1 ("strongly disagree") to 4 ("strongly agree"). Total scores range from 17 to 68, with higher scores indicating greater levels of kinesiophobia. A score above 37 typically suggests a high degree of fear related to movement. Although the TSK primarily measures fear of movement, it can also indirectly reflect barriers to engagement in physical therapy.
Measured: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
Change from Baseline in the Short Form Health Survey (SF-36) at 3 and 7 weeks
SF-36 is a widely used 36-item questionnaire designed to assess health-related quality of life across various populations, including patients with chronic conditions. It evaluates eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional health, and mental health. Each domain is scored on a scale from 0 to 100, with higher scores indicating better health status and quality of life.
Measured: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
Change from Baseline in the Patient Health Questionnaire (PHQ-9) at 3 and 7 weeks
A nine-item instrument specifically designed for screening and assessing the severity of depression in primary care settings. Each item corresponds to a diagnostic criterion for major depressive disorder and asks respondents to reflect on their experiences over the past two weeks. Responses are scored on a scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate more severe depressive symptoms, with scores of 5 or higher typically suggesting mild depression, and scores above 15 indicating moderate to severe depression.
Measured: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
Change from Baseline in the Exercise Capacity and Endurance at 3 and 7 weeks
The exercise conditions will be induced through a RAMP exercise test conducted on a treadmill, starting at a speed of 2.0 km/h with a 0% grade. Every 10 seconds, the speed and grade will increase incrementally by 0.1 to 0.15 km/h and 0.1% to 0.2%, respectively. To assess exercise capacity and endurance, metabolic equivalents (METs) will be calculated by determining the ratio of the metabolic work rate during exercise to the resting metabolic rate.
Measured: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
Secondary outcomes (4)
Change from baseline in the autonomic nervous system activity at 3 and 7 weeks
Autonomic nervous system activity will be assessed using heart rate variability (HRV), a measure that can serve as an indicator of psychological responses to stress. HRV will be recorded using the Polar H10 chest strap during a 5-minute measurement in a seated position. This method provides a reliable assessment of autonomic regulation, reflecting the balance between sympathetic and parasympathetic nervous system activity.
Measured: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks
Change from Baseline in the Perceived Stress Scale (PSS-10) at 3 and 7 weeks
A tool for evaluating the level of perceived stress experienced by patients. This questionnaire consists of 10 items assessing various subjective feelings related to personal issues, life events, behaviors, and coping strategies over the past month. Respondents rate how often they have felt stressed or overwhelmed on a 5-point Likert scale, ranging from 0 ("never") to 4 ("very often"). Higher scores indicate greater levels of perceived stress, making it a valuable measure for understanding the impact of stress on patients' overall well-being.
Measured: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
Change from Baseline in the functional capacity at 3 and 7 weeks
Functional capacity will be assessed using the 6-Minute Walk Test (6MWT), which measures the distance a patient can walk in six minutes. This test provides valuable insights into exercise tolerance and overall physical ability. It is particularly effective for monitoring treatment efficacy, as improvements in walking distance often correlate with symptom relief and enhanced quality of life. The 6MWT is a submaximal exercise test that reflects the patient's functional capacity during daily activities, making it a practical and reliable measure, especially for individuals with moderate to severe cardiac or pulmonary conditions.
Measured: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
Daily physical activity levels during the rehabilitation period
Physical activity levels will be assessed using a pedometer by recording step count with Yamax SW800-SW801 Digi-Walker Pedometer. The pedometer will be assigned to patients upon their qualification for the study, with instructions to use it throughout their entire stay.
Measured: From enrollment to the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Jan Dlugosz University in Czestochowa, Provincial Specialist Hospital of the Blessed Virgin Mary in Częstochowa
- Responsible party
- Principal investigator, Błażej Cieślik, Wroclaw University of Health and Sport Sciences
- Investigators
- Błażej Cieślik, PhD., Principal investigator, Jan Dlugosz University in CzestochowaKarolina Kowalewska, MSc., Principal investigator, Jan Dlugosz University in Czestochowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896318
- Sponsor's protocol ID
- 54/2024
- Status last verified
- Jun 2025
- First submitted
- 7 Feb 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-Supported Cardiac Rehabilitation: Psychological, Functional, and Physiological Perspectives
- ClinicalTrials.gov ID
- NCT06896318
- Acronym / sponsor ID
- 54/2024
- Conditions
- Cardiovascular Diseases, Coronary Arterial Disease (CAD), Myocardial Disease, Heart Disease
- Keywords
- virtual reality, relaxation, cardiac rehabilitation, kinesiophobia, stress, depression, new technologies, heart disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- Jan Dlugosz University in Czestochowa, Provincial Specialist Hospital of the Blessed Virgin Mary in Częstochowa
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 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 study aims to evaluate the effectiveness of virtual reality-assisted cardiac rehabilitation compared to conventional cardiac rehabilitation in improving psychological outcomes-depression, stress, anxiety, and kinesiophobia-along with physiological parameters, functional status, physical activity levels, and quality of life in cardiac patients.
Detailed description
This single-blind randomized controlled trial will include 60 participants aged 60 years and older undergoing Phase II CR at the Provincial Specialist Hospital of the Blessed Virgin Mary in Częstochowa, Poland. Participants will be randomly assigned to one of two groups: a conventional CR program or a VR-CR group. Both groups will complete a three-week hospital-based CR program involving structured group exercises, interval cycling, and relaxation sessions. The experimental group will additionally receive eight sessions of immersive VR therapy using the VRTierOne device, consisting of 20-minute sessions twice weekly. These sessions employ interactive and calming virtual environments to promote relaxation and psychological engagement. Outcome measures will be evaluated at baseline (week 0), post-intervention (week 3), and follow-up (week 7). Assessments will include Patient-Reported Outcome Measures for stress, depression, kinesiophobia, and quality of life, physiological metrics (heart rate, blood pressure, metabolic equivalents), HRV, functional capacity (6MWT), and physical activity levels measured using the pedometers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Group | Experimental | Device: Virtual Reality Therapy, Behavioral: Cardiac rehabilitationCardiac rehabilitation supplemented by VR therapy |
| Control Group | Active comparator | Behavioral: Cardiac rehabilitationConventional cardiac rehabilitation |
Who may qualify
- Ages
- 60 months to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- cardiovascular diseases (atherosclerosis, hypertension, coronary artery disease, ischemic heart disease, peripheral artery disease, rheumatic heart disease, deep vein thrombosis, pulmonary embolism, and post-myocardial infraction)
- the second stage of cardiac rehabilitation conducted in outpatient settings
Key exclusion criteria (5 listed)
- Severe psychiatric disorders (e.g., psychotic symptoms, bipolar disorder)
- initiation of psychiatric treatment or individual psychological therapy during the study period
- current use of antidepressant medications
- cognitive impairments that hinder questionnaire completion, consciousness disorders
- sensory impairments (e.g., severe visual or auditory deficits) that limit interaction with virtual reality.
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 Reality Therapy8 sessions of VR therapy (each of them 20 minutes long). As a virtual reality source, VR TierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach.The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation. | Device | VR Group |
| Cardiac rehabilitationA three-week, hospital-based cardiac rehabilitation program for all participants, incorporating structured group exercises and activities. The conventional cardiac rehabilitation program includes morning warm-up exercises, afternoon group sessions, interval training on stationary bikes, and relaxation activities. Morning sessions consist of 20 minutes of standing cardiovascular exercises accompanied by music, while afternoon sessions include 45 minutes of seated activities, divided into cardiovascular, equipment-based, and breathing exercises. | Behavioural | Control Group, VR Group |
Primary outcome
Change from Baseline in the Tampa Scale for Kinesiophobia (TSK) at 3 and 7 weeks
Time frame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
TSK consists of 17 items designed to assess fear of movement and re-injury (kinesiophobia) in individuals experiencing pain or undergoing rehabilitation. Each item presents a statement regarding beliefs about movement and pain, with respondents indicating their level of agreement on a scale from 1 ("strongly disagree") to 4 ("strongly agree"). Total scores range from 17 to 68, with higher scores indicating greater levels of kinesiophobia. A score above 37 typically suggests a high degree of fear related to movement. Although the TSK primarily measures fear of movement, it can also indirectly reflect barriers to engagement in physical therapy.
Change from Baseline in the Short Form Health Survey (SF-36) at 3 and 7 weeks
Time frame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
SF-36 is a widely used 36-item questionnaire designed to assess health-related quality of life across various populations, including patients with chronic conditions. It evaluates eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional health, and mental health. Each domain is scored on a scale from 0 to 100, with higher scores indicating better health status and quality of life.
Change from Baseline in the Patient Health Questionnaire (PHQ-9) at 3 and 7 weeks
Time frame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
A nine-item instrument specifically designed for screening and assessing the severity of depression in primary care settings. Each item corresponds to a diagnostic criterion for major depressive disorder and asks respondents to reflect on their experiences over the past two weeks. Responses are scored on a scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate more severe depressive symptoms, with scores of 5 or higher typically suggesting mild depression, and scores above 15 indicating moderate to severe depression.
Change from Baseline in the Exercise Capacity and Endurance at 3 and 7 weeks
Time frame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
The exercise conditions will be induced through a RAMP exercise test conducted on a treadmill, starting at a speed of 2.0 km/h with a 0% grade. Every 10 seconds, the speed and grade will increase incrementally by 0.1 to 0.15 km/h and 0.1% to 0.2%, respectively. To assess exercise capacity and endurance, metabolic equivalents (METs) will be calculated by determining the ratio of the metabolic work rate during exercise to the resting metabolic rate.
4 secondary outcomes
Change from baseline in the autonomic nervous system activity at 3 and 7 weeks
Time frame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks
Change from Baseline in the Perceived Stress Scale (PSS-10) at 3 and 7 weeks
Time frame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
Change from Baseline in the functional capacity at 3 and 7 weeks
Time frame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
Daily physical activity levels during the rehabilitation period
Time frame: From enrollment to the end of treatment at 3 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 24 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Błażej Cieślik, PhD. principal investigator
Jan Dlugosz University in Czestochowa
Karolina Kowalewska, MSc. principal investigator
Jan Dlugosz University in Czestochowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Therapy and Cardiac rehabilitation in people with Cardiovascular Diseases and Coronary Arterial Disease (CAD), run by Wroclaw University of Health and Sport Sciences at 2 sites in Poland.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Change from Baseline in the Tampa Scale for Kinesiophobia (TSK) at 3 and 7 weeks (time frame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.). The study lists 4 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 24 Jun 2025.