- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06332859
Effectiveness of a Resilience-Based Rehabilitation Program for Patients With Coronary Heart Disease
Effectiveness of a Resilience-based Rehabilitation Program in Patients With TakoTsubo Cardiomyopathy and After Acute Coronary Syndrome
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marina Kuzdas-Sallaberger, MSc.
- Phone Number: 0043 50303 26710
- Email: marina.kuzdas-sallaberger@pv.at
Study Contact Backup
- Name: Stefan Gschwenter, MA
- Phone Number: 0043 50303 26722
- Email: stefan.gschwenter@pv.at
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TakoTsubo
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.
|
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.
|
Experimental: Acute coronary event
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 weeks of inpatient rehabilitation + 6 month follow-up
|
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.
|
3 weeks of inpatient rehabilitation + 6 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)
Time Frame: 3 weeks of inpatient rehabilitation + 6 month follow-up
|
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. |
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
|
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.
|
3 weeks of inpatient rehabilitation + 6 month follow-up
|
Maximal incremental exercise test
Time Frame: 3 weeks of inpatient rehabilitation
|
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.
|
3 weeks of inpatient rehabilitation
|
Work ability index (WAI)
Time Frame: 3 weeks of inpatient rehabilitation + 6 month follow-up
|
The Work Ability Index (WAI) is an instrument for assessing work ability.
(Min.
= 7, Max = 49).
Lower values indicate less subjective work ability.
|
3 weeks of inpatient rehabilitation + 6 month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: David Felder, Mag., Austrian Pension Insurance Institution
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FOR-0022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Coronary Syndrome
-
Yonsei UniversityRecruitingCoronary Artery Disease, Acute Coronary SyndromeKorea, Republic of
-
Meditrix CorpNational University of Ireland, Galway, Ireland; Boston Scientific Japan K.K.; Fujita Health UniversityRecruitingChronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromeJapan, Ireland
-
OrbusNeichDuke Clinical Research Institute; OrbusNeich Medical K.K.CompletedCoronary Arteriosclerosis | Non ST Segment Elevation Acute Coronary SyndromeUnited States, Japan
-
Medical University of WarsawRecruitingAcute Coronary Syndrome | Chronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromePoland
-
Niguarda HospitalCompletedAcute Coronary Syndrome With ST Elevation on Electrocardiogram | Acute Coronary Syndrome Without ST Elevation on Electrocardiogram | Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent | Aortic AneurysmsItaly
-
Sohag UniversityRecruitingLeft Main Coronary Artery Disease With Acute Coronary SyndromeEgypt
-
Eli Lilly and CompanyDaiichi Sankyo, Inc.CompletedCoronary Arteriosclerosis | Acute Coronary SyndromesUnited States
-
University of PatrasCompletedCoronary Artery Disease (CAD) | Acute Coronary Syndrome (ACS)Greece
-
The First Affiliated Hospital with Nanjing Medical...Unknown
-
Yonsei UniversityCompletedAcute Coronary Syndrome (ACS)Korea, Republic of
Clinical Trials on Resilience training
-
Military Academy at ETH ZurichSwiss Armed ForcesCompletedPsychological Stress | Psychological AdaptationSwitzerland
-
Massachusetts General HospitalCompletedPsychotic Disorders | Mood Disorders | Anxiety DisordersUnited States
-
Massachusetts General HospitalRecruitingPsychotic Disorders | Mood Disorders | Anxiety DisordersUnited States
-
University Hospital, Basel, SwitzerlandRecruitingAutism Spectrum Disorder | Life Change EventsSwitzerland
-
Mayo ClinicCompleted
-
Ataturk UniversityAtaturk UniversityEnrolling by invitationDepression | Fear of ChildbirthTurkey
-
University of New MexicoJohns Hopkins University; University of Nevada, Las VegasRecruiting
-
University of OttawaCompleted
-
Massachusetts General HospitalNot yet recruitingDepressive Disorder | Psychotic Disorders | Anxiety Disorders | Psychosocial Functioning
-
Morehouse School of MedicineHarvard Medical School (HMS and HSDM)Active, not recruitingChronic PainUnited States