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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change from Baseline in the Tampa Scale for Kinesiophobia (TSK) at 3 and 7 weeks — From enrollment to the end of treatment at 3 weeks and follow-up at 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.
• Change from Baseline in the Short Form Health Survey (SF-36) at 3 and 7 weeks — From enrollment to the end of treatment at 3 weeks and follow-up at 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.
• Change from Baseline in the Patient Health Questionnaire (PHQ-9) at 3 and 7 weeks — From enrollment to the end of treatment at 3 weeks and follow-up at 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.
• Change from Baseline in the Exercise Capacity and Endurance at 3 and 7 weeks — From enrollment to the end of treatment at 3 weeks and follow-up at 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.

Trial sites (2)

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