Virtual Therapy as a Method Supporting the Cardiac Rehabilitation

November 27, 2019 updated by: Joanna Szczepańska-Gieracha, University School of Physical Education in Wroclaw

Evaluation of the Effectiveness of Immersive Virtual Reality Therapy as a Method Supporting the Cardiac Rehabilitation

This study evaluates the effectiveness of virtual reality (VR) therapy in the treatment of depression and anxiety symptoms in patients undergoing second stage of cardiac rehabilitation. Half of the study group will receive VR therapy (VR group) as an addition to cardiologically monitored physical training. The other half of the group (control group) will receive Schultz Autogenic Training as a standard supplement to cardiological training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cardiologically monitored physical training in second stage of cardiac rehabilitation leads to the improvement in the physical capacity and overall fitness of the patients with Coronary Artery Disease, allowing restoration of independence in daily functioning. Psychological support is required in order to reduce the negative psychological symptoms related to both the heart disease itself and the cardiac surgery performed. In this study the investigators want to assess the effectiveness of the virtual reality (VR) therapy compared to standard psychological support (Schultz Autogenic Training).

Thanks to using head mounted display and the phenomenon of total immersion VR therapy allows to completely separate the patient from the hospital environment, provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or, in another part of the therapy, it can motivate the patient to the rehabilitation process. The additional aim of the VR therapy is to help the patients regain their emotional balance, let them recognize their psychological resources and trigger the natural recovery mechanisms.

The goals of the project:

  1. The evaluation of the influence of VR therapy on the depressive symptoms and the anxiety level of the patients undergoing second stage of cardiac rehabilitation.
  2. The evaluation of the influence of VR therapy on the stress level of the patients undergoing second stage of cardiac rehabilitation.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Dolnośląskie
      • Wroclaw, Dolnośląskie, Poland, 51-612
        • University School of Physical Education
      • Wrocław, Dolnośląskie, Poland, 52-244
        • Centrum Kardiologiczne Pro Corde Sp. z o.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Coronary Artery Disease;
  • the second stage of cardiac rehabilitation conducted in outpatient settings;
  • anxiety symptoms scored 8 and more in HADS-A or depressive symptoms scored 8 and more in HADS-D.

Exclusion Criteria:

  • cognitive impairment (MMSE<24);
  • inability to self-complete the research questionnaires;
  • presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
  • initiation of psychiatric treatment during the research project;
  • contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
  • the patient's refusal at any stage of the research project.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: VR therapy group
Cardiac rehabilitation supplemented by VR therapy
Behavioral: Cardiac rehabilitation
Four weeks of cardiac rehabilitation conducted in an outpatient care facility. Three times per week (80 minutes per day) cardiologically monitored aerobic training consisting of: 40 minutes of interval training on a cycloergometer and 40 minutes of general fitness exercises.
Device: Virtual therapeutic support

8 sessions of VR therapy (each of them 20 minutes long).

As a virtual reality source, VR Tier One 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. By performing tasks in the virtual garden, the patient becomes an active participant of the therapeutic process and sees the effects his/her work.
ACTIVE_COMPARATOR: Control Group
Cardiac rehabilitation supplemented by Schultz Autogenic Training
Behavioral: Cardiac rehabilitation
Four weeks of cardiac rehabilitation conducted in an outpatient care facility. Three times per week (80 minutes per day) cardiologically monitored aerobic training consisting of: 40 minutes of interval training on a cycloergometer and 40 minutes of general fitness exercises.
Behavioral: Standard therapeutic support
8 sessions of Schultz Autogenic Training (each of them 20 minutes long).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 15 minutes
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of Stress Questionnaire (PSQ)
Time Frame: 30 minutes
The Perception of Stress Questionnaire (PSQ) is a 27-item scale scoring from 1 to 5 for each item. 21 items examine the level of stress in the area of emotional tension, external stress and intrapsychic stress, and 6 items refer to the lie scale. The global scoring for perception of stress ranges from 21 to 105 with a cut-off point of 60 for high level of perceived stress. The higher the score, the greater the sense of stress. PSQ will be performed at the beginning and after four weeks of treatment.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University School of Physical Education in Wroclaw

Collaborators

Foundation for Senior Citizen Activation SIWY DYM

Investigators

  • Study Chair: Sandra Jóźwik, University School of Physical Education, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 6, 2019

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

October 30, 2019

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (ACTUAL)

August 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2019

Last Update Submitted That Met QC Criteria

November 27, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59/0203/S/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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