Adherence, PatientVirtualCORENCT04166422
Virtual Reality and Video Games in Cardiac Rehabilitation Programs
A study testing Cardiac rehabilitation program and Experimental intervention in people with Adherence, Patient and Physical Disability, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Cardiovascular diseases (CVD) are the leading cause of morbidity and mortality in developed countries. The consequent healthcare costs in Europe alone are estimated at 196,000 million euros annually, approximately 54% of the total investment in health, resulting in productivity losses of 24% [1-3]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence, Patient, Physical Disability, Cardiovascular Diseases
- What is being tested?
- Cardiac rehabilitation program and Experimental intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 12 Nov 2019to 11 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- either male or female;
- agegreater than 18 years;
- a diagnosis of CVD confirmed by a Cardiologist;
- information available on risk stratification, Killip level and functional class (NYHA), level according to the Canadian Cardiovascular Society Scale or the Goldman Physical Activity Scale;
- information available on METS in ergometry and ejection fraction and compliance with the indications described in relation to CR.
Who cannot join
- pregnancy or planned pregnancy,
- high cardiovascular risk,
- the presence of a pacemaker,
- conditions that make it difficult or impossible to use VR, such as the presence of visual or auditory deficiencies, learning problems, cognitive deterioration, psychiatric pathology or the use of support products for walking or standing,
- the presence of other serious neurological, musculoskeletal or lung diseases,
- uncompensated metabolic disorders,
- previous cardiorespiratory arrest
- a history of photosensitive epilepsy due to the use of video games.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality and Video Games in Cardiac Rehabilitation Programs. A Randomized Controlled Trial
Cardiovascular diseases (CVD) are the leading cause of morbidity and mortality in developed countries. The consequent healthcare costs in Europe alone are estimated at 196,000 million euros annually, approximately 54% of the total investment in health, resulting in productivity losses of 24% [1-3]. In recent years, the impact of CVD in non-Western countries has been growing [4,5]; therefore, prevention is presented as a primordial tool to improve quality of life and patient survival [6,7]. Cardiac rehabilitation (CR) is defined as a multidisciplinary program of clinical application of preventive measures for risk reduction and global and long-term care of the cardiac patient. In secondary prevention, it is shown to reduce the morbimortality by almost 50% in patients with heart disease. However, the participation of patients in cardiac rehabilitation remains low, especially among the following groups: the elderly, women and patients with a low socioeconomic profile. According to the latest Euroaspire V data, participation in CR programs in Spain is around 50%. The Reureca registry reports that only 10% of patients with a CR indication attend the programs. Therefore, new technologies within the health field, specifically within cardiac rehabilitation programs through the use of virtual reality (VR) and video games, are shown as promising aids with the aim of increasing adherence, satisfaction with programs and participation rates, offering the ability to perform physical exercise [8-11]. Virtual reality is a simulation of a real or imaginary environment created by a computer system, which allows the user to feel immersed and to interact with objects in that environment [12-14]. Thus, the basic elements that constitute a VR system are simulation, interaction and immersion [15]. Moreover, the creation of more adaptable and accessible videogame platforms has meant that the phenomenon of technological expansion can be understood not only as a form of leisure but also as an important means of learning and skills training, especially in people with motor, cognitive and sensory (neurological and non-neurological) deficits [16]. In contrast to traditional CR procedures, which can be repetitive, causing a loss of interest on the part of patients, video games and VR systems offer the opportunity to participate in enjoyable tasks with a therapeutic purpose through physical interaction with the game. The design of exercise-based videogames (exergames) provides the possibility of practicing physical skills in an entertaining way and of adjusting the game according to the abilities of the subject and the level of intensity. In addition, it is known that the level of enjoyment of an activity has been identified as one of the predictive factors of the effectiveness of an exercise program, and for this reason, interactive technology based on exercise is becoming the all-time most popular strategy for the implementation of physical activity [17-23]. It is important to emphasize that VR allows the creation of environments suitable for activities related to CR. The users of these systems can develop simulated tasks and activities in a safe way, since the clinicians have the capacity to control the duration and intensity of the exercise and, in this way, to control and supervise the delivery of stimuli in the virtual environment [24]. Furthermore, knowledge of results regarding the performance of the task in real time, gained through extrinsic feedback, as well as the playful nature of the activities proposed through VR and videogame devices, generates a competitiveness and challenge component that further increases the degree of patient motivation. In this regard, Klasen et al. [25] point out that this increase in motivation is related to the influence of videogames on activation of the mesolimbic dopaminergic pathways and their repercussions on the reward system of the brain. All this promotes active participation on the part of the patient and thus increases adherence to the rehabilitation treatment. The aim of the present work is to carry out a RCT to provide information on the application of VR and videogame systems within CR programs in patients with cardiac diseases.
- Conditions
- Adherence, Patient, Physical Disability, Cardiovascular Diseases, Treatment Adherence, Satisfaction
- Being tested
- Cardiac rehabilitation program, Experimental intervention
- Medical subject headings
- Patient Compliance, Cardiovascular Diseases, Treatment Adherence and Compliance, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitation programOther
Aerobic treatment plus strength exercises
Experimental interventionOther
Aerobic treatment plus strengh exercises plus virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | Active comparator | Conventional rehabilitation treatment Receives: Other: Cardiac rehabilitation program |
| Experimental group | Experimental | Virtual reality plus conventional rehabilitation treatment Receives: Other: Experimental intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
METS in ergometry and ejection fraction
Ergometry is a science that measures work. A device that can be used to measure work is called an ergometer
Measured: 8 weeks
Secondary outcomes (3)
6 minute walking test
How long, in meters, walk a patients in 6 minutes
Measured: 8 weeks
Functional Independence Measure (MIF)
This is an instrument that evaluates the inability of patients with functional restrictions of various causes; it quantitatively evaluates the care demand of a person for performing motor and cognitive tasks of daily living.
Measured: 8 weeks
Short Form Quality of Life (SF36)
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start12 Nov 2019
- Primary completion11 Nov 2020 (estimated)
- Study completion11 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, PatientStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166422
- Sponsor's protocol ID
- VIRTUAL CORE URJC
- Acronym
- VirtualCORE
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Video Games in Cardiac Rehabilitation Programs. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04166422
- Acronym / sponsor ID
- VirtualCORE / VIRTUAL CORE URJC
- Conditions
- Adherence, Patient, Physical Disability, Cardiovascular Diseases, Treatment Adherence, Satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 11 Nov 2020 (estimated)
- Study completion
- 11 Nov 2021 (estimated)
- First posted
- 18 Nov 2019 (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.
Cardiovascular diseases (CVD) are the leading cause of morbidity and mortality in developed countries. The consequent healthcare costs in Europe alone are estimated at 196,000 million euros annually, approximately 54% of the total investment in health, resulting in productivity losses of 24% [1-3]. In recent years, the impact of CVD in non-Western countries has been growing [4,5]; therefore, prevention is presented as a primordial tool to improve quality of life and patient survival [6,7]. Cardiac rehabilitation (CR) is defined as a multidisciplinary program of clinical application of preventive measures for risk reduction and global and long-term care of the cardiac patient. In secondary prevention, it is shown to reduce the morbimortality by almost 50% in patients with heart disease. However, the participation of patients in cardiac rehabilitation remains low, especially among the following groups: the elderly, women and patients with a low socioeconomic profile. According to the latest Euroaspire V data, participation in CR programs in Spain is around 50%. The Reureca registry reports that only 10% of patients with a CR indication attend the programs. Therefore, new technologies within the health field, specifically within cardiac rehabilitation programs through the use of virtual reality (VR) and video games, are shown as promising aids with the aim of increasing adherence, satisfaction with programs and participation rates, offering the ability to perform physical exercise [8-11]. Virtual reality is a simulation of a real or imaginary environment created by a computer system, which allows the user to feel immersed and to interact with objects in that environment [12-14]. Thus, the basic elements that constitute a VR system are simulation, interaction and immersion [15]. Moreover, the creation of more adaptable and accessible videogame platforms has meant that the phenomenon of technological expansion can be understood not only as a form of leisure but also as an important means of learning and skills training, especially in people with motor, cognitive and sensory (neurological and non-neurological) deficits [16]. In contrast to traditional CR procedures, which can be repetitive, causing a loss of interest on the part of patients, video games and VR systems offer the opportunity to participate in enjoyable tasks with a therapeutic purpose through physical interaction with the game. The design of exercise-based videogames (exergames) provides the possibility of practicing physical skills in an entertaining way and of adjusting the game according to the abilities of the subject and the level of intensity. In addition, it is known that the level of enjoyment of an activity has been identified as one of the predictive factors of the effectiveness of an exercise program, and for this reason, interactive technology based on exercise is becoming the all-time most popular strategy for the implementation of physical activity [17-23]. It is important to emphasize that VR allows the creation of environments suitable for activities related to CR. The users of these systems can develop simulated tasks and activities in a safe way, since the clinicians have the capacity to control the duration and intensity of the exercise and, in this way, to control and supervise the delivery of stimuli in the virtual environment [24]. Furthermore, knowledge of results regarding the performance of the task in real time, gained through extrinsic feedback, as well as the playful nature of the activities proposed through VR and videogame devices, generates a competitiveness and challenge component that further increases the degree of patient motivation. In this regard, Klasen et al. [25] point out that this increase in motivation is related to the influence of videogames on activation of the mesolimbic dopaminergic pathways and their repercussions on the reward system of the brain. All this promotes active participation on the part of the patient and thus increases adherence to the rehabilitation treatment. The aim of the present work is to carry out a RCT to provide information on the application of VR and videogame systems within CR programs in patients with cardiac diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Active comparator | Other: Cardiac rehabilitation programConventional rehabilitation treatment |
| Experimental group | Experimental | Other: Experimental interventionVirtual reality plus conventional rehabilitation treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- either male or female;
- agegreater than 18 years;
- a diagnosis of CVD confirmed by a Cardiologist;
- information available on risk stratification, Killip level and functional class (NYHA), level according to the Canadian Cardiovascular Society Scale or the Goldman Physical Activity Scale;
- information available on METS in ergometry and ejection fraction and compliance with the indications described in relation to CR.
Key exclusion criteria (8 listed)
- pregnancy or planned pregnancy,
- high cardiovascular risk,
- the presence of a pacemaker,
- conditions that make it difficult or impossible to use VR, such as the presence of visual or auditory deficiencies, learning problems, cognitive deterioration, psychiatric pathology or the use of support products for walking or standing,
- the presence of other serious neurological, musculoskeletal or lung diseases,
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 |
|---|---|---|
| Cardiac rehabilitation programAerobic treatment plus strength exercises | Other | Conventional group |
| Experimental interventionAerobic treatment plus strengh exercises plus virtual reality | Other | Experimental group |
Primary outcome
METS in ergometry and ejection fraction
Time frame: 8 weeks
Ergometry is a science that measures work. A device that can be used to measure work is called an ergometer
3 secondary outcomes
6 minute walking test
Time frame: 8 weeks
Functional Independence Measure (MIF)
Time frame: 8 weeks
Short Form Quality of Life (SF36)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation program and Experimental intervention in people with Adherence, Patient and Physical Disability, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Nov 2019. 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 Spain. 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?
Results are not available in the source record.
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?
METS in ergometry and ejection fraction (time frame: 8 weeks). 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 18 Nov 2019.