Supporting Methods in Cardiovascular Diseases Rehabilitation

July 9, 2024 updated by: Adam Wrzeciono, MSc, Wroclaw University of Health and Sport Sciences

Evaluation of the Effectiveness of Modern Technologies in Psychologically-enhanced Rehabilitation in Patients With Cardiovascular Diseases

The study evaluates how various therapeutic approaches perform in addressing depression, anxiety symptoms, and stress levels among patients in the second stage of cardiac rehabilitation. This study aims to evaluate the influence of the used therapeutic approaches on psychological outcomes and to compare the effectiveness of these therapies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression, anxiety, and high levels of perceived stress are increasingly common problems associated with cardiovascular disease (CVD). The relationship between anxiety-depressive disorders and the risk of CVD is confirmed by behavioral and physiological mechanisms. According to the American Heart Association, depression is a negative prognostic factor at all stages of treatment of CVD. The most important risks in people with CVD and anxiety-depressive disorders, as comorbidities, are an increased risk of recurrent cardiovascular events and increased mortality. However, psychological disorders in patients with CVD are still not sufficiently diagnosed and, consequently, are not adequately treated. Therefore, it is necessary to look for effective methods to support cardiac rehabilitation from a psychological perspective.

The first group of patients will receive relaxation-therapeutic recordings (referred to as the Recording Group) in addition to monitored cardiac physical training. The second group will receive virtual reality (VR) therapy (referred to as the VR Group) alongside monitored cardiac physical training. The third group (referred to as the Control Group) will receive Schultz Autogenic Training as a standard supplement to cardiological training.

The aims of the study:

  1. The evaluation of the influence of relaxation-therapeutic recordings on the anxiety-depressive symptoms and the stress level of the patients undergoing second stage of cardiac rehabilitation.
  2. The comparison of the effectiveness of therapeutic recordings with the effectiveness of VR therapy and Schultz Autogenic Training.

Study Type

Interventional

Enrollment (Actual)

45

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
      • Wrocław, Poland
        • Cardiology Center Pro Corde

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Coronary Artery Disease;
  • the second stage of cardiac rehabilitation conducted in outpatient settings

Exclusion Criteria:

  • 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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recordings Group
Cardiac rehabilitation supplemented by relaxation-therapeutic recordings
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: Relaxation-therapeutic recordings

8 sessions of relaxation-therapeutic recordings in the non-sleep deep rest concept.

The content of the recording is based on the 'body scanning technique', which constitutes the core of the therapy. This approach aims to quiet the overactive sympathetic part of the autonomic nervous system. During therapy, the patients take a 'journey' through their own body from feet to head. Following the voice of the narrator, the patient focuses on specific body parts, tries to feel this place and then relaxes tense muscles. Relaxation of individual body parts (muscle groups) is combined with breathing exercises. Conscious and mindful breathing deepens the state of relaxation. Additionally, the recording includes therapeutic suggestions related to making a choice between: overload and relief, holding on and letting go, acting and sensing. Furthermore, suggestions focus the patient on inner wisdom that allows them to make the best decisions.
Experimental: VR 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 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.
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: Schultz Autogenic Training
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
Perception of Stress Questionnaire
Time Frame: 20 minutes
The Perception of Stress Questionnaire (PSQ) was created by Plopa and Makarowski. It is a 27-item scale scoring from 1 to 5 points for each item, where 21 items examine the level of stress in the areas of emotional tension, external stress and intrapsychic stress, and six items refer to the lie scale. The global scoring for the perception of stress ranges from 21 to 105, with a cut-off point of 60 for an elevated level of perceived stress. Higher scores indicate higher stress perception.
20 minutes
Hospital Anxiety and Depression Scale Hospital Anxiety and Depression Scale
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

Collaborators and Investigators

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

Sponsor

Wroclaw University of Health and Sport Sciences

Collaborators

Gajda-Med District Hospital
Cardiology Center Pro Corde
Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital

Investigators

  • Study Director: Joanna Szczepańska-Gieracha, Prof., Wroclaw University of Health and Sport Sciences
  • Principal Investigator: Adam Wrzeciono, MSc., Wroclaw University of Health and Sport Sciences
  • Principal Investigator: Sandra Jóźwik, Ph.D., Cardiology Center Pro Corde
  • Study Chair: Błażej Cieślik, Ph.D., Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital
  • Study Chair: Paweł Kiper, Ph.D., Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital
  • Study Director: Robert Gajda, Prof., Gajda-Med District Hospital

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)

February 1, 2024

Primary Completion (Actual)

April 15, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT/CR/01/2023

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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