Virtual Reality and Video Games in Cardiac Rehabilitation Programs (VirtualCORE)
Virtual Reality and Video Games in Cardiac Rehabilitation Programs. A Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Alcorcón, Madrid, Spain, 28922
- Roberto Cano de la Cuerda
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
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
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- VIRTUAL CORE URJC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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