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

NCT06896318 | Active Not Recruiting

• 1 other identifier: 54/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

virtual reality; relaxation; cardiac rehabilitation; kinesiophobia; stress; depression; new technologies; heart disease

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in the Tampa Scale for Kinesiophobia (TSK) at 3 and 7 weeks

  TSK consists of 17 items designed to assess fear of movement and re-injury (kinesiophobia) in individuals experiencing pain or undergoing rehabilitation. Each item presents a statement regarding beliefs about movement and pain, with respondents indicating their level of agreement on a scale from 1 ("strongly disagree") to 4 ("strongly agree"). Total scores range from 17 to 68, with higher scores indicating greater levels of kinesiophobia. A score above 37 typically suggests a high degree of fear related to movement. Although the TSK primarily measures fear of movement, it can also indirectly reflect barriers to engagement in physical therapy.

  From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.

• Change from Baseline in the Short Form Health Survey (SF-36) at 3 and 7 weeks

  SF-36 is a widely used 36-item questionnaire designed to assess health-related quality of life across various populations, including patients with chronic conditions. It evaluates eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional health, and mental health. Each domain is scored on a scale from 0 to 100, with higher scores indicating better health status and quality of life.

  From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.

• Change from Baseline in the Patient Health Questionnaire (PHQ-9) at 3 and 7 weeks

  A nine-item instrument specifically designed for screening and assessing the severity of depression in primary care settings. Each item corresponds to a diagnostic criterion for major depressive disorder and asks respondents to reflect on their experiences over the past two weeks. Responses are scored on a scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate more severe depressive symptoms, with scores of 5 or higher typically suggesting mild depression, and scores above 15 indicating moderate to severe depression.

  From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.

• Change from Baseline in the Exercise Capacity and Endurance at 3 and 7 weeks

  The exercise conditions will be induced through a RAMP exercise test conducted on a treadmill, starting at a speed of 2.0 km/h with a 0% grade. Every 10 seconds, the speed and grade will increase incrementally by 0.1 to 0.15 km/h and 0.1% to 0.2%, respectively. To assess exercise capacity and endurance, metabolic equivalents (METs) will be calculated by determining the ratio of the metabolic work rate during exercise to the resting metabolic rate.

  From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.

Secondary Outcomes (4)

• Change from baseline in the autonomic nervous system activity at 3 and 7 weeks

  From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks

• Change from Baseline in the Perceived Stress Scale (PSS-10) at 3 and 7 weeks

  From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.

• Change from Baseline in the functional capacity at 3 and 7 weeks

  From enrollment to the end of treatment at 3 weeks and follow-up at 7 weeks.

• Daily physical activity levels during the rehabilitation period

  From enrollment to the end of treatment at 3 weeks

Study Arms (2)

VR Group

EXPERIMENTAL

Cardiac rehabilitation supplemented by VR therapy

Device: Virtual Reality Therapy; Behavioral: Cardiac rehabilitation

Control Group

ACTIVE COMPARATOR

Conventional cardiac rehabilitation

Behavioral: Cardiac rehabilitation

Interventions

Virtual Reality Therapy 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.

VR Group

Cardiac rehabilitation 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; VR Group

Eligibility Criteria

• Age: 60 Months - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Jan Dlugosz University in Czestochowa: collaborator
• Provincial Specialist Hospital of the Blessed Virgin Mary in Częstochowa: collaborator

Study Sites (2)

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

Częstochowa, Upper Silesia, 42-200, Poland

Location

Jan Dlugosz University in Czestochowa

Częstochowa, Upper Silesia, 42-200, Poland

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Cardiomyopathies; Heart Diseases; Kinesiophobia; Depression

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Błażej Cieślik, PhD.

  Jan Dlugosz University in Czestochowa

  PRINCIPAL INVESTIGATOR

• Karolina Kowalewska, MSc.

  Jan Dlugosz University in Czestochowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: March 26, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)