Clinical trial NCT06896318: Virtual Reality-Supported Cardiac Rehabilitation: Psychological, Functional, and Physiological Perspectives
Official title: Virtual Reality-Supported Cardiac Rehabilitation: Psychological, Functional, and Physiological Perspectives
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Arterial Disease (CAD)
Myocardial Disease
Heart Disease
Keywords: virtual reality
relaxation
cardiac rehabilitation
kinesiophobia
stress
depression
new technologies
heart disease
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: Jan Dlugosz University in Czestochowa
name: Provincial Specialist Hospital of the Blessed Virgin Mary in Częstochowa
First posted: 2025-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in the Tampa Scale for Kinesiophobia (TSK) at 3 and 7 weeks
timeFrame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
measure: Change from Baseline in the Short Form Health Survey (SF-36) at 3 and 7 weeks
timeFrame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
measure: Change from Baseline in the Patient Health Questionnaire (PHQ-9) at 3 and 7 weeks
timeFrame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
measure: Change from Baseline in the Exercise Capacity and Endurance at 3 and 7 weeks
timeFrame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
Secondary outcomes:
measure: Change from baseline in the autonomic nervous system activity at 3 and 7 weeks
timeFrame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks
measure: Change from Baseline in the Perceived Stress Scale (PSS-10) at 3 and 7 weeks
timeFrame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
measure: Change from Baseline in the functional capacity at 3 and 7 weeks
timeFrame: From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.
measure: Daily physical activity levels during the rehabilitation period
timeFrame: From enrollment to the end of treatment at 3 weeks
Other outcomes:
Locations:
city: Czestochowa
country: Poland
facility: Cardiac Rehabilita6on Department of the Provincial Specialist Hospital of the Blessed Virgin Mary in Czestochowa, Poland
state: Upper Silesia
city: Czestochowa
country: Poland
facility: Jan Dlugosz University in Czestochowa
state: Upper Silesia
Study officials:
affiliation: Jan Dlugosz University in Czestochowa
name: Błażej Cieślik, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jan Dlugosz University in Czestochowa
name: Karolina Kowalewska, MSc.
role: PRINCIPAL_INVESTIGATOR
References: