Brief Summary: Cardiac rehabilitation (CR) is a multi-factorial intervention, designed to limit the physiological and psychological effects of cardiovascular disease such as coronary artery disease (CAD), manage symptoms, and reduce the risk of future cardiovascular events. CR is a structured program not only addressing CAD but also comorbidities including hypertension, dyslipidemia, diabetes and obesity as well as other risk factors. CR aims at long-term lifestyle changes to reduce modifiable risk factors, and it's success depends on a large number of interacting variables including biological, psychological and social factors. Recently, the importance of patient-centered approaches to secondary prevention and CR success has been underlined but intra-individual factors and their interactions are not well understood. The TIMELY prospective study aims to collect high-resolution data for data mining and artificial intelligence machine learning models to identify dependencies between factors and predict favorable outcomes of CR. Data collection will include data documented during controlled center-based CR as well as remote-measurement of physical activity data, (central) blood pressure and pulse wave analysis as well as long-term ECG data during a 6-months period after discharge. Follow-up assessments will be performed at least at 6 months and at 12 months after discharge. Events (MACCE) will be collected for up to 10 years. After 2023, the study will be run under the acronym PrädiktoR. Main objectives of the study: 1. To examine uptake and adherence to a healthy lifestyle (i. e. adherence to CR guidelines in CAD) and the effects on long-term outcomes. 2. To identify potentially mediating mechanisms and predictive factors for long-term CR success in CAD, also to be used in machine learning models and for the generation of digital twins. 3. To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR.
Study Type
OBSERVATIONAL
Enrollment
1,200
Klinik Königsfeld
Ennepetal, North Rhine-Westphalia, Germany
RECRUITINGChange in Cardiorespiratory Fitness (CRF)
CRF will be measured as maximal oxygen uptake (VO2max) determined by spiroergometry
Time frame: Baseline, week 3, week 24, and week 48
Change in risk of mortality
Risk of mortality will be determined using the validated biomarker risk score COROPREDICT
Time frame: Baseline, week 3, week 24, and week 48
Number of patients with major adverse cardiac and cerebrovascular events (MACCE)
Number of patients with death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization, and major bleeding
Time frame: Baseline to week 48, and week 432
Physical activity (PA)
PA will be measured by validated BSA questionnaire (Bewegungs- und Sportaktivität) and expressed as metabolic equivalents
Time frame: Baseline, week 3, week 24, and week 48
Daily step count
Steps will be measured using electronic devices such as wrist-worn activity trackers
Time frame: Baseline to week 24
Weekly number and duration of physical activities
Number and duration of physical activities will be measured using electronic devices such as wrist-worn activity trackers
Time frame: Baseline to week 24
Resting heart rate
Resting heart rate will be measured using electronic devices such as wrist-worn activity trackers
Time frame: Baseline to week 24
Sleep duration
Sleep duration will be measured using electronic devices such as wrist-worn activity trackers
Time frame: Baseline to week 24
Physiological stress
Physiological stress will be measured using electronic devices such as wrist-worn activity trackers
Time frame: Baseline to week 24
Blood pressure
Central and peripheral systolic and diastolic blood pressure will be measured using automatic upper-arm sphygmomanometers. Data transmitted by telemetry.
Time frame: Baseline to week 24
Arterial pressure wave propagation/reflection characteristics
Arterial pressure wave propagation/reflection characteristics will be measured using automatic upper-arm tonometry. Data transmitted by telemetry.
Time frame: Baseline to week 24
Cardiac arrhythmia
Cardiac arrhythmia will be measured using three-channel Holter ECG.
Time frame: Baseline to week 24
Body composition
Body composition including fat mass, muscle mass, and visceral fat area will be measured by bioimpedance analysis.
Time frame: Baseline, week 3, and week 24, and week 48
Muscle strength
Arm and leg extension and flexion strength will be measured using Isokinetic devices
Time frame: Baseline, week 3, and week 24
Muscle function
Muscle function will be measured by 30-second chair rise test
Time frame: Baseline, week 3, and week 24, and week 48
Submaximal exercise capacity
Submaximal exercise capacity will be measured using 6-min walking test
Time frame: Baseline, week 3, and week 24, and week 48
Habit formation
Habit formation will be assessed using validated questionnaire for the "Self-Report Behavioural Automaticity Index (SRBAI)".
Time frame: Baseline, week 3, week 24, and week 48
Nicotine dependence
Nicotine dependence will be assessed using the Fagerström questionnaire
Time frame: Baseline, week 3, week 24, and week 48
Cardiac Self-Efficacy
Cardiac Self-Efficacy will be assessed using the validated "Cardiac Self-Efficacy Scale (CSE)"
Time frame: Baseline, week 3, week 24, and week 48
Impact of disease
Impact of disease will be assessed using the "brief illness perception (IPQ-9)" questionnaire .
Time frame: Baseline, week 3, week 24, and week 48
General wellbeing
General wellbeing will be assessed using the "Positive And Negative Affect Scale (PANAS)" questionnaire .
Time frame: Baseline, week 3, week 24, and week 48
Fear of Activity/ Kinesiophobia
Fear of Activity/ Kinesiophobia will be assessed using the modified "Fear of Activity Scale (FActS)".
Time frame: Baseline, week 3, week 24, and week 48
Depression
Depression will be assessed using the modified "Patient Health Questionnaire (PHQ-9)".
Time frame: Baseline, week 3, week 24, and week 48
General anxiety
General anxiety will be assessed using the "7-item General Anxiety Scale (GAD-7)".
Time frame: Baseline, week 3, week 24, and week 48
Health-related quality of life
Health-related quality of life will be assessed using the "RAND 36-Item Health Survey (SF-36)".
Time frame: Baseline, week 3, week 24, and week 48
General quality of life
Quality of life will be assessed using the "5-level EQ-5D (EQ-5D-5L) health status measure".
Time frame: Baseline, week 3, week 24, and week 48
Wellbeing
Wellbeing will be assessed using the "WHO-5 Well-Being Index".
Time frame: Baseline, week 3, week 24, and week 48
Perceived stress
Perceived stress will be assessed using the "Perceived Stress Scale (PSS-4)".
Time frame: Baseline, week 3, week 24, and week 48
Optimism/ Pessimism
Optimism/ Pessimism will be assessed using the modified "Life Orientation Test (LOT-R)".
Time frame: Baseline, week 3, week 24, and week 48
Conscientiousness
Conscientiousness will be assessed using the "The Big Five Inventor (BFI-10)".
Time frame: Baseline, week 3, week 24, and week 48
Psychological flexibility
Psychological flexibility will be assessed using the psychometric properties of the "Acceptance and Action Questionnaire-I (AAQ-II)".
Time frame: Baseline, week 3, week 24, and week 48
Negative Affectivity
Standard assessment of negative affectivity, social inhibition, and Type D personality (DS-14)
Time frame: Baseline, week 3, week 24, and week 48
Trait anger
Trait anger will be assessed using the "State-Trait Anger Expression Inventory-2 ("TAI-10/STAXI-2").
Time frame: Baseline, week 3, week 24, and week 48
Religiousness/ spirituality
Religiousness/ spirituality will be assessed using the "Spiritual and Religious Attitudes in Dealing with Illness (GrAw-7/ SpREUK-15)" questionnaire.
Time frame: Baseline, week 3, week 24, and week 48
Fatigue
Fatigue will be assessed using the "The Multidimensional Fatigue Inventory (MFI20)".
Time frame: Baseline, week 3, week 24, and week 48
Psychological situation in the working environment
Psychological situation in the working environment will be assessed using the "The effort-reward imbalance model (ERI10+6)".
Time frame: Baseline, week 3, week 24, and week 48
Work requirements and workload
Work requirements and workload will be assessed using the "Workability Index (WAI)".
Time frame: Baseline, week 3, week 24, and week 48
Social support
Social support will be assessed using the short "Perceived Social Support Questionnaire (F-SozU K6)".
Time frame: Baseline, week 3, week 24, and week 48
Relationship satisfaction
Relationship satisfaction will be assessed using the "Quality of Marriage Index (QMI)".
Time frame: Baseline, week 3, week 24, and week 48
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