Supporting Methods in Cardiovascular Diseases Rehabilitation

NCT06241534 | Completed

• 1 other identifier: RCT/CR/01/2023
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Mood Disorders; Depressive Symptoms; Anxiety; Stress

Keywords

cardiac rehabilitation; psychotherapy; therapeutic recordings; virtual reality; depression; anxiety; stress

Outcome Measures

Primary Outcomes (2)

• Hospital Anxiety and Depression Scale Hospital Anxiety and Depression Scale

  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

• Perception of Stress Questionnaire

  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

Study Arms (3)

Recordings Group

EXPERIMENTAL

Cardiac rehabilitation supplemented by relaxation-therapeutic recordings

Behavioral: Cardiac rehabilitation; Behavioral: Relaxation-therapeutic recordings

VR Group

EXPERIMENTAL

Cardiac rehabilitation supplemented by VR therapy

Behavioral: Cardiac rehabilitation; Device: Virtual reality therapy

Control Group

ACTIVE COMPARATOR

Cardiac rehabilitation supplemented by Schultz Autogenic Training

Behavioral: Cardiac rehabilitation; Behavioral: Schultz Autogenic Training

Interventions

Cardiac rehabilitation BEHAVIORAL

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.

Control Group; Recordings Group; VR Group

Relaxation-therapeutic recordings BEHAVIORAL

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.

Recordings Group

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

Schultz Autogenic Training BEHAVIORAL

8 sessions of Schultz Autogenic Training (each of them 20 minutes long).

Control Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Gajda-Med District Hospital: collaborator
• Cardiology Center Pro Corde: collaborator
• Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital: collaborator

Study Sites (1)

Cardiology Center Pro Corde

Wroclaw, Poland

Location

Related Publications (7)

• Natt Och Dag Y, Mehlig K, Rosengren A, Lissner L, Rosvall M. Negative emotional states and negative life events: Consequences for cardiovascular health in a general population. J Psychosom Res. 2020 Feb;129:109888. doi: 10.1016/j.jpsychores.2019.109888. Epub 2019 Nov 29.

  PMID: 31835155 BACKGROUND

• Silverman AL, Herzog AA, Silverman DI. Hearts and Minds: Stress, Anxiety, and Depression: Unsung Risk Factors for Cardiovascular Disease. Cardiol Rev. 2019 Jul/Aug;27(4):202-207. doi: 10.1097/CRD.0000000000000228.

  PMID: 30130257 BACKGROUND

• Szczepanska-Gieracha J, Morka J, Kowalska J, Kustrzycki W, Rymaszewska J. The role of depressive and anxiety symptoms in the evaluation of cardiac rehabilitation efficacy after coronary artery bypass grafting surgery. Eur J Cardiothorac Surg. 2012 Nov;42(5):e108-14. doi: 10.1093/ejcts/ezs463. Epub 2012 Aug 19.

  PMID: 22906598 BACKGROUND

• Szczepanska-Gieracha J, Jozwik S, Cieslik B, Mazurek J, Gajda R. Immersive Virtual Reality Therapy as a Support for Cardiac Rehabilitation: A Pilot Randomized-Controlled Trial. Cyberpsychol Behav Soc Netw. 2021 Aug;24(8):543-549. doi: 10.1089/cyber.2020.0297. Epub 2021 Feb 11.

  PMID: 33577375 BACKGROUND

• Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. Evaluation of the Impact of Virtual Reality-Enhanced Cardiac Rehabilitation on Depressive and Anxiety Symptoms in Patients with Coronary Artery Disease: A Randomised Controlled Trial. J Clin Med. 2021 May 16;10(10):2148. doi: 10.3390/jcm10102148.

  PMID: 34065625 BACKGROUND

• Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. The Use of Virtual Therapy in Cardiac Rehabilitation of Female Patients with Heart Disease. Medicina (Kaunas). 2021 Jul 28;57(8):768. doi: 10.3390/medicina57080768.

  PMID: 34440974 BACKGROUND

• Jozwik S, Wrzeciono A, Cieslik B, Kiper P, Szczepanska-Gieracha J, Gajda R. The Use of Virtual Therapy in Cardiac Rehabilitation of Male Patients with Coronary Heart Disease: A Randomized Pilot Study. Healthcare (Basel). 2022 Apr 16;10(4):745. doi: 10.3390/healthcare10040745.

  PMID: 35455922 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Mood Disorders; Depression; Anxiety Disorders

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; 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

• Joanna Szczepańska-Gieracha, Prof.

  Wroclaw University of Health and Sport Sciences

  STUDY DIRECTOR

• Adam Wrzeciono, MSc.

  Wroclaw University of Health and Sport Sciences

  PRINCIPAL INVESTIGATOR

• Sandra Jóźwik, Ph.D.

  Cardiology Center Pro Corde

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Robert Gajda, Prof.

  Gajda-Med District Hospital

  STUDY DIRECTOR

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: MSc

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: February 1, 2024
• Primary Completion: April 15, 2024
• Study Completion: May 31, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)