Takotsubo CardiomyopathyNCT06332859
Effectiveness of a Resilience-Based Rehabilitation Program for Patients With Coronary Heart Disease
A study testing Resilience training in people with Takotsubo Cardiomyopathy and Acute Coronary Syndrome, run by Pensionsversicherungsanstalt at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Takotsubo Cardiomyopathy, Acute Coronary Syndrome, Psychological Resilience
- What is being tested?
- Resilience training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteAustria
- Study dates
- 15 Apr 2024to 14 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute intercurrent illness (longer than 3 days)
- No sufficient knowledge of German to enable participation in the resilience training (assessment by recruiting person)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Rehabilitationszentrum Bad Tatzmannsdorf
Bad Tatzmannsdorf, Burgenland, 7431
Jeanette Strametz-Juranek, Univ.-Prof. Dr., +435030343202, jeanette.strametz-juranek@pv.at
About this study
Official title: Effectiveness of a Resilience-based Rehabilitation Program in Patients With TakoTsubo Cardiomyopathy and After Acute Coronary Syndrome
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.
Read the 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.
- Being tested
- Resilience training
- Medical subject headings
- Takotsubo Cardiomyopathy, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Resilience training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 weeks of inpatient rehabilitation + 6 month follow-up
Secondary outcomes (4)
European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)
The EQ-5D-5L is a general instrument for measuring patient-reported outcomes (PROs), which can be used to assess the quality of life of patients on different dimensions (mobility, self-care, usual activities, pain/discomfort) on a 5-level scale (Min. = 0, Max. = 5). Lower values indicate less impairments in the respective dimensions.
Moreover, the EQ-5D-5L assesses the patient's self-rated health on a 100 point visual analog scale (Min. = 0, Max. =100). Lower values indicate less positive ratings of health.
Measured: 3 weeks of inpatient rehabilitation + 6 month follow-up
Patient Health Questionnaire-4 (PHQ-4)
The Patient Health Questionnaire-4 (PHQ-4) operationalizes core criteria for anxiety and depression on a 4 point likert scale (Min. = 0, Max = 4). Lower values indicate less impairments.
Measured: 3 weeks of inpatient rehabilitation + 6 month follow-up
Maximal incremental exercise test
The maximal incremental exercise test is performed on a stationary cycle ergometer. The size of the increments is personalized (5-30 watt) for each patient based on their predicted peak work. Increments are increased every minute, allowing the patient to reach peak workload within 8-12 minutes.
Measured: 3 weeks of inpatient rehabilitation
Work ability index (WAI)
The Work Ability Index (WAI) is an instrument for assessing work ability. (Min. = 7, Max = 49). Lower values indicate less subjective work ability.
Measured: 3 weeks of inpatient rehabilitation + 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start15 Apr 2024
- Primary completion14 Oct 2026 (estimated)
- Study completion14 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takotsubo CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pensionsversicherungsanstalt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doreen Stöhr, Mag., Study chair, Austrian Pension Insurance Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332859
- Sponsor's protocol ID
- FOR-0022
- Status last verified
- Jul 2026
- First submitted
- 20 Mar 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Resilience-based Rehabilitation Program in Patients With TakoTsubo Cardiomyopathy and After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT06332859
- Acronym / sponsor ID
- FOR-0022
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- PensionsversicherungsanstaltUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 14 Oct 2026 (estimated)
- Study completion
- 14 Oct 2026 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TakoTsubo | Experimental | Other: Resilience trainingIndividuals 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. |
| Acute coronary event | Experimental | Other: Resilience trainingIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Acute intercurrent illness (longer than 3 days)
- No sufficient knowledge of German to enable participation in the resilience training (assessment by recruiting person)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilience trainingThe 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. | Other | Acute coronary event, TakoTsubo |
Primary outcome
Resilience scale-13 (RS-13)
Time frame: 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)
Time frame: 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.
4 secondary outcomes
European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)
Time frame: 3 weeks of inpatient rehabilitation + 6 month follow-up
Patient Health Questionnaire-4 (PHQ-4)
Time frame: 3 weeks of inpatient rehabilitation + 6 month follow-up
Maximal incremental exercise test
Time frame: 3 weeks of inpatient rehabilitation
Work ability index (WAI)
Time frame: 3 weeks of inpatient rehabilitation + 6 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doreen Stöhr, Mag. study chair
Austrian Pension Insurance Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience training in people with Takotsubo Cardiomyopathy and Acute Coronary Syndrome, run by Pensionsversicherungsanstalt at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Kuzdas-Sallaberger, MSc. (0043 50303 26710, marina.kuzdas-sallaberger@pv.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience scale-13 (RS-13) (time frame: 3 weeks of inpatient rehabilitation + 6 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.