Viewing Study NCT06332859



Ignite Creation Date: 2024-05-06 @ 8:18 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06332859
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-27
First Post: 2024-03-20

Brief Title: Effectiveness of a Resilience-Based Rehabilitation Program for Patients With Coronary Heart Disease
Sponsor: Pensionsversicherungsanstalt
Organization: Pensionsversicherungsanstalt

Study Overview

Official Title: Effectiveness of a Resilience-based Rehabilitation Program in Patients With TakoTsubo Cardiomyopathy and After Acute Coronary Syndrome
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 individuals 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None