Virtual Reality-Supported Cardiac Rehabilitation: Psychological, Functional, and Physiological Perspectives

Wroclaw University of Health and Sport Sciences

Status: Active, not recruiting

Conditions: Coronary Arterial Disease (CAD); Myocardial Disease; Cardiovascular Diseases; Heart Disease

Treatments: Behavioral: Cardiac rehabilitation; Device: Virtual Reality Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06896318

54/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60 months to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

VR Group

Experimental group

Description:

Cardiac rehabilitation supplemented by VR therapy

Treatment:

Device: Virtual Reality Therapy

Behavioral: Cardiac rehabilitation

Control Group

Active Comparator group

Description:

Conventional cardiac rehabilitation

Treatment:

Behavioral: Cardiac rehabilitation