- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04166422
Virtual Reality and Video Games in Cardiac Rehabilitation Programs (VirtualCORE)
November 14, 2019 updated by: Josue Fernandez Carnero, Universidad Rey Juan Carlos
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Madrid
-
Alcorcón, Madrid, Spain, 28922
- Roberto Cano de la Cuerda
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Conventional group
Conventional rehabilitation treatment
|
Aerobic treatment plus strength exercises
|
EXPERIMENTAL: Experimental group
Virtual reality plus conventional rehabilitation treatment
|
Aerobic treatment plus strengh exercises plus virtual reality
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 minute walking test
Time Frame: 8 weeks
|
How long, in meters, walk a patients in 6 minutes
|
8 weeks
|
Functional Independence Measure (MIF)
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Short Form Quality of Life (SF36)
Time Frame: 8 weeks
|
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to the therapy sessions
Time Frame: 8 weeks
|
the attendance rate (%) for therapy sessions
|
8 weeks
|
Satisfaction questionaire
Time Frame: 8 weeks
|
which evaluate the level of satisfaction regarding the care and quality of the service received and the level of fulfillment of the patient's expectations regarding the treatment administered
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 12, 2019
Primary Completion (ANTICIPATED)
November 11, 2020
Study Completion (ANTICIPATED)
November 11, 2021
Study Registration Dates
First Submitted
November 11, 2019
First Submitted That Met QC Criteria
November 14, 2019
First Posted (ACTUAL)
November 18, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 18, 2019
Last Update Submitted That Met QC Criteria
November 14, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIRTUAL CORE URJC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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