Effectiveness of a Resilience-Based Rehabilitation Program for Patients With Coronary Heart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPensionsversicherungsanstalt
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Acute intercurrent illness (longer than 3 days)
No sufficient knowledge of German to enable participation in the resilience training (assessment by recruiting person)
Trial design
Design model
Parallel
Treatments tested in this trial
Resilience training
Other interventionThe 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.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: TakoTsuboExperimental treatment 1 intervention
Group B: Acute coronary eventExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 weeks of inpatient rehabilitation + 6 month follow-up2
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.
Time frame
3 weeks of inpatient rehabilitation + 6 month follow-upSecondary outcomes
1
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.
Time frame
3 weeks of inpatient rehabilitation + 6 month follow-up2
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.
Time frame
3 weeks of inpatient rehabilitation + 6 month follow-up3
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.
Time frame
3 weeks of inpatient rehabilitation4
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.
Time frame
3 weeks of inpatient rehabilitation + 6 month follow-upSponsors and contacts
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Source ClinicalTrials.gov