Effectiveness of a Resilience-Based Rehabilitation Program for Patients with Coronary Heart Disease

NCT06332859 | Recruiting

• 1 other identifier: FOR-0022
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

To handle daily life challenges, one needs to be psychologically resilient. It plays a crucial role in disease development, prognosis, as well as social, occupational, and community participation. Cardiovascular diseases cause physical and psychological stress, which can be linked to individual resilience and the development of such diseases. Stress can trigger TakoTsubo cardiomyopathy and acute coronary events. Individuals who have experienced TakoTsubo cardiomyopathy or an acute coronary event often feel stressed due to emotional or physical triggers. These triggers may include job loss or illness. In medical rehabilitation, therapists consider the individual circumstances of their patients when planning therapy. It may be important to add a special focus on psychological care, including building resilience, which could greatly benefit these individuals. Therefore, the study aims to investigate whether resilience training, as part of an inpatient multidisciplinary rehabilitation program, affects the individual resilience of rehabilitants with TakoTsubo cardiomyopathy or those who have experienced an acute coronary event.

Conditions

Takotsubo Cardiomyopathy; Acute Coronary Syndrome; Psychological Resilience

Outcome Measures

Primary Outcomes (2)

• Resilience scale-13 (RS-13)

  The resilience scale-13 measures individual resilience using 13 items on a 7-point Likert scale. The RS-13 scale measures the following aspects of the resilience concept: optimism, emotional stability, zest for life, energy, openness to new things and the ability to change perspective. It can be divided into two factors (competence and acceptance) and describe overall resilience. The scale values range from 1 = "strongly disagree" to 7 = "strongly agree". Higher values meaning higher resilience.

  3 weeks of inpatient rehabilitation + 6 month follow-up

• Brief Resilience scale - German Version (BRS)

  The brief resilience scale (German Version) measures the self-assessment of an individual's ability to recover from stress despite considerable adversity. The BSR-D consists of six items. The items are rated on a 5-point likert scale (1 = strongly disagree to 5 = strongly agree). Higher values meaning higher resilience.

  3 weeks of inpatient rehabilitation + 6 month follow-up

Secondary Outcomes (4)

• European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)

  3 weeks of inpatient rehabilitation + 6 month follow-up

• Patient Health Questionnaire-4 (PHQ-4)

  3 weeks of inpatient rehabilitation + 6 month follow-up

• Maximal incremental exercise test

  3 weeks of inpatient rehabilitation

• Work ability index (WAI)

  3 weeks of inpatient rehabilitation + 6 month follow-up

Study Arms (2)

TakoTsubo

EXPERIMENTAL

Individuals with TakoTsubo cardiomyopathy who participate in an inpatient rehabilitation programme receive an additional psychological intervention, specifically resilience training. This is not a common practice in such rehabilitation programmes.

Other: Resilience training

Acute coronary event

EXPERIMENTAL

Individuals after an acute coronary event who participate in an inpatient rehabilitation programme receive an additional psychological intervention, specifically resilience training. This is not a common practice in such rehabilitation programmes.

Other: Resilience training

Interventions

Resilience training OTHER

The resilience training consists of two sessions of psychological group therapy, each lasting 100 minutes, with a special focus on resilience. Additionally, there are two sessions of relaxation training, known as 'heart yoga', each lasting 25 minutes.

Acute coronary event; TakoTsubo

Eligibility Criteria

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

You may qualify if:

• patients experienced TakoTsubo cardiomyopathy (I42.88, I42.9) or patients after an acute coronary event (I21.9) (max. 6 month post event)
• older than 18 years
• signed consent form

You may not qualify if:

• Acute intercurrent illness (longer than 3 days)
• No sufficient knowledge of German to enable participation in the resilience training (assessment by recruiting person)

Sponsors & Collaborators

• Pensionsversicherungsanstalt: lead

Study Sites (1)

Rehabilitationszentrum Bad Tatzmannsdorf

Bad Tatzmannsdorf, Burgenland, 7431, Austria

RECRUITING

MeSH Terms

Conditions

Takotsubo Cardiomyopathy; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Myocardial Ischemia; Vascular Diseases

Study Officials

• Doreen Stöhr, Mag.

  Austrian Pension Insurance Institution

  STUDY CHAIR

Central Study Contacts

Marina Kuzdas-Sallaberger, MSc.

CONTACT

0043 50303 26710; marina.kuzdas-sallaberger@pv.at

Stefan Gschwenter, MA

CONTACT

0043 50303 26722; stefan.gschwenter@pv.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): October 14, 2026
• Last Updated: March 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)