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

NCT ID: NCT06896318

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR Group

Cardiac rehabilitation supplemented by VR therapy

Group Type: EXPERIMENTAL

Virtual Reality Therapy

Intervention Type: DEVICE

8 sessions of VR therapy (each of them 20 minutes long). As a virtual reality source, VR TierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach.The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation.

Cardiac rehabilitation

Intervention Type: BEHAVIORAL

A three-week, hospital-based cardiac rehabilitation program for all participants, incorporating structured group exercises and activities. The conventional cardiac rehabilitation program includes morning warm-up exercises, afternoon group sessions, interval training on stationary bikes, and relaxation activities. Morning sessions consist of 20 minutes of standing cardiovascular exercises accompanied by music, while afternoon sessions include 45 minutes of seated activities, divided into cardiovascular, equipment-based, and breathing exercises.

Control Group

Conventional cardiac rehabilitation

Group Type: ACTIVE_COMPARATOR

Cardiac rehabilitation

Intervention Type: BEHAVIORAL

A three-week, hospital-based cardiac rehabilitation program for all participants, incorporating structured group exercises and activities. The conventional cardiac rehabilitation program includes morning warm-up exercises, afternoon group sessions, interval training on stationary bikes, and relaxation activities. Morning sessions consist of 20 minutes of standing cardiovascular exercises accompanied by music, while afternoon sessions include 45 minutes of seated activities, divided into cardiovascular, equipment-based, and breathing exercises.

Interventions

Virtual Reality Therapy

8 sessions of VR therapy (each of them 20 minutes long). As a virtual reality source, VR TierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach.The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation.

Intervention Type: DEVICE

Cardiac rehabilitation

A three-week, hospital-based cardiac rehabilitation program for all participants, incorporating structured group exercises and activities. The conventional cardiac rehabilitation program includes morning warm-up exercises, afternoon group sessions, interval training on stationary bikes, and relaxation activities. Morning sessions consist of 20 minutes of standing cardiovascular exercises accompanied by music, while afternoon sessions include 45 minutes of seated activities, divided into cardiovascular, equipment-based, and breathing exercises.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 60 Months
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jan Dlugosz University in Czestochowa

OTHER

Sponsor Role: collaborator

Provincial Specialist Hospital of the Blessed Virgin Mary in Częstochowa

UNKNOWN

Sponsor Role: collaborator

Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role: lead

Responsible Party

Błażej Cieślik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Błażej Cieślik, PhD.

Role: PRINCIPAL_INVESTIGATOR

Jan Dlugosz University in Czestochowa

Karolina Kowalewska, MSc.

Role: PRINCIPAL_INVESTIGATOR

Jan Dlugosz University in Czestochowa

Locations

Cardiac Rehabilita6on Department of the Provincial Specialist Hospital of the Blessed Virgin Mary in Czestochowa, Poland

Częstochowa, Upper Silesia, Poland

Jan Dlugosz University in Czestochowa

Częstochowa, Upper Silesia, Poland

Countries

Poland

Other Identifiers

54/2024

Identifier Type: -

Identifier Source: org_study_id