跳至主要内容
临床试验/NCT06332859
NCT06332859招募中不适用

Effectiveness of a Resilience-based Rehabilitation Program in Patients With TakoTsubo Cardiomyopathy and After Acute Coronary Syndrome

Pensionsversicherungsanstalt2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
130
试验地点
2
主要终点
Resilience scale-13 (RS-13)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Resilience training (Other)

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.

干预措施: Resilience training (Other)

结局指标

主要结局

Resilience scale-13 (RS-13)

时间窗: 3 weeks of inpatient rehabilitation + 6 month follow-up

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.

Brief Resilience scale - German Version (BRS)

时间窗: 3 weeks of inpatient rehabilitation + 6 month follow-up

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.

次要结局

  • Work ability index (WAI)(3 weeks of inpatient rehabilitation + 6 month follow-up)
  • Maximal incremental exercise test(3 weeks of inpatient rehabilitation)
  • Patient Health Questionnaire-4 (PHQ-4)(3 weeks of inpatient rehabilitation + 6 month follow-up)
  • European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)(3 weeks of inpatient rehabilitation + 6 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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