Clinical trial NCT06332859: Effectiveness of a Resilience-Based Rehabilitation Program for Patients with Coronary Heart Disease
Official title: Effectiveness of a Resilience-based Rehabilitation Program in Patients with TakoTsubo Cardiomyopathy and After Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Takotsubo Cardiomyopathy
Acute Coronary Syndrome
Psychological Resilience
Lead sponsor: Pensionsversicherungsanstalt
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: To cope with the demands of everyday life, individuals require a certain level of psychological resilience. Resilience can be defined in various ways, such as the interplay between vulnerability (risk factors) and protection (resources). Another definition of resilience is the ability to adapt positively to stressful circumstances or to remain functionally stable and healthy despite prolonged stress. Resilience is a crucial factor in determining the quality of life and the psychosocial behaviour of an individual. Therefore, measuring individual resilience can help to understand an individual's resistance to stress and to initiate appropriate therapeutic interventions. There is evidence to suggest that cardiovascular diseases can cause increased physical and psychological stress in patients, potentially indicating a link between individual resilience and cardiovascular disease. Specifically, stress can lead to conditions such as takotsubo cardiomyopathy and acute coronary events. Individuals with takotsubo cardiomyopathy or those who have experienced an acute coronary event often encounter stress as a result of acute emotional or physical triggers, such as job loss or illness. Additionally, those affected often describe long-lasting stress, such as post-traumatic stress disorder or suppression of emotions, before the onset of symptoms.

The symptom complex of takotsubo cardiomyopathy are similar to those of an acute myocardial infarction, but without narrowed coronary arteries. Additionally, takotsubo cardiomyopathy is more prevalent in postmenopausal women. Studies have shown that the mortality rate of takotsubo cardiomyopathy is higher than previously assumed. Additionally, the long-term mortality of patients with takotsubo cardiomyopathy is higher than that of patients after a heart attack.

As medical rehabilitation is a commonly used method for treating cardiovascular diseases. It has been shown to be effective in sustaining the benefits of acute hospital treatment. However, this approach is often overlooked in patients with takotsubo cardiomyopathy, despite its proven positive effects.

A multidisciplinary team can provide individualized care to patients as part of a medical rehabilitation process. The provision of psychological support, such as coping strategies and resilience building, could be of great benefit to people undergoing rehabilitation for takotsubo cardiomyopathy. Research indicates that patients diagnosed with takotsubo cardiomyopathy often struggle to manage stress for an extended period following their diagnosis and initial treatment, which can negatively impact their quality of life and participation. Furthermore, compared to the general population, patients who have been treated for an acute cardiac event, such as an acute myocardial infarction, have lower stress tolerance.

Therefore, the aim of this research project is to assess the effectiveness of a resilience-focused rehabilitation programme for people with takotsubo cardiomyopathy or who have experienced an acute coronary event.

This study will examine changes in psychological resilience, as measured by two independent resilience scales (Resilience Scale-13 and Brief Resilience Scale), during three weeks of inpatient rehabilitation and assess sustainability of these changes after completion of rehabilitation (six-month follow-up). Additionally, participation-related parameters (health-related quality of life, psychological distress and work ability) and physical performance (incremental cycle ergometry) will also be considered.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Resilience scale-13 (RS-13)
timeFrame: 3 weeks of inpatient rehabilitation + 6 month follow-up
measure: Brief Resilience scale - German Version (BRS)
timeFrame: 3 weeks of inpatient rehabilitation + 6 month follow-up
Secondary outcomes:
measure: European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)
timeFrame: 3 weeks of inpatient rehabilitation + 6 month follow-up
measure: Patient Health Questionnaire-4 (PHQ-4)
timeFrame: 3 weeks of inpatient rehabilitation + 6 month follow-up
measure: Maximal incremental exercise test
timeFrame: 3 weeks of inpatient rehabilitation
measure: Work ability index (WAI)
timeFrame: 3 weeks of inpatient rehabilitation + 6 month follow-up
Other outcomes:
Locations:
city: Bad Tatzmannsdorf
country: Austria
facility: Rehabilitationszentrum Bad Tatzmannsdorf
state: Burgenland
Study officials:
affiliation: Austrian Pension Insurance Institution
name: Doreen Stöhr, Mag.
role: STUDY_CHAIR
References: