NCT04166422: VirtualCORE

Virtual Reality and Video Games in Cardiac Rehabilitation Programs

Status unknown NA Last updated 18 November 2019

What this trial tests

NA trial testing Cardiac rehabilitation program in Adherence, Patient in 30 participants. Status unknown.

Timeline

12 November 2019

Primary endpoint
11 November 2020

11 November 2021

Quick facts

Lead sponsor	Universidad Rey Juan Carlos
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	12 November 2019
Primary completion	11 November 2020
Estimated completion	11 November 2021
Sites	1 location across Spain

Drugs / interventions tested

• Cardiac rehabilitation program
• Experimental intervention — full drug profile →

Conditions studied

• Adherence, Patient — all drugs for Adherence, Patient →
• Physical Disability — all drugs for Physical Disability →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Treatment Adherence — all drugs for Treatment Adherence →

Sponsor

Universidad Rey Juan Carlos — full company profile →

Who can join

18 and older, any sex, with Adherence, Patient or Physical Disability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Virtual Reality on Cardiac Rehabilitation Programs for Ischemic Heart Disease: A Randomized Pilot Clinical Trial.
   García-Bravo S, Cano-de-la-Cuerda R, Domínguez-Paniagua J, Campuzano-Ruiz R, et al · · 2020 · cited 32× · PMID 33207670 · DOI 10.3390/ijerph17228472