TIMELY Prospective Study

Active, not recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05461729
• Lead Sponsor: Dr. Boris Schmitz

Brief Summary

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.

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.

3. To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-18
• Primary Completion: 2023-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 612

Inclusion Criteria

Coronary Artery Disease (CAD) patients after myocardial infarction (STEMI/NSTEMI) and/or angioplasty and/or Percutaneous Coronary Intervention (PCI) and/or coronary artery bypass graft surgery who participate in phase II Cardiac Rehabilitation (CR).

Exclusion Criteria

• Incapability to give informed consent
• Conditions that prevent patients from participation in CR including unstable coronary or cerebrovascular conditions and acute infections

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Cardiorespiratory Fitness (CRF)	Baseline, week 3, and week 24	CRF will be measured as maximal oxygen uptake (VO2max) determined by spiroergometry
Number of patients with major adverse cardiac and cerebrovascular events (MACCE)	Baseline to week 48	Number of patients with death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization, and major bleeding
Change in risk of mortality	Baseline, week 3, and week 24	Risk of mortality will be determined using the validated biomarker risk score COROPREDICT

Secondary Outcome Measures

Name	Time	Method
Wellbeing	Baseline, week 3, week 24, and week 48	Wellbeing will be assessed using the "WHO-5 Well-Being Index".
Resting heart rate	Baseline to week 24	Resting heart rate will be measured using electronic devices such as wrist-worn activity trackers
Fear of Activity/ Kinesiophobia	Baseline, week 3, week 24, and week 48	Fear of Activity/ Kinesiophobia will be assessed using the modified "Fear of Activity Scale (FActS)".
Sleep duration	Baseline to week 24	Sleep duration will be measured using electronic devices such as wrist-worn activity trackers
Physical activity (PA)	Baseline, week 3, week 24, and week 48	PA will be measured by validated BSA questionnaire (Bewegungs- und Sportaktivität) and expressed as metabolic equivalents
Weekly number and duration of physical activities	Baseline to week 24	Number and duration of physical activities will be measured using electronic devices such as wrist-worn activity trackers
Physiological stress	Baseline to week 24	Physiological stress will be measured using electronic devices such as wrist-worn activity trackers
Blood pressure	Baseline to week 24	Central and peripheral systolic and diastolic blood pressure will be measured using automatic upper-arm sphygmomanometers. Data transmitted by telemetry.
Arterial pressure wave propagation/reflection characteristics	Baseline to week 24	Arterial pressure wave propagation/reflection characteristics will be measured using automatic upper-arm tonometry. Data transmitted by telemetry.
Muscle strength	Baseline, week 3, and week 24	Arm and leg extension and flexion strength will be measured using Isokinetic devices
Body composition	Baseline, week 3, and week 24	Body composition including fat mass, muscle mass, and visceral fat area will be measured by bioimpedance analysis.
Muscle function	Baseline, week 3, and week 24	Muscle function will be measured by 30-second chair rise test
Cardiac Self-Efficacy	Baseline, week 3, week 24, and week 48	Cardiac Self-Efficacy will be assessed using the validated "Cardiac Self-Efficacy Scale (CSE)"
General wellbeing	Baseline, week 3, week 24, and week 48	General wellbeing will be assessed using the "Positive And Negative Affect Scale (PANAS)" questionnaire .
Perceived stress	Baseline, week 3, week 24, and week 48	Perceived stress will be assessed using the "Perceived Stress Scale (PSS-4)".
Conscientiousness	Baseline, week 3, week 24, and week 48	Conscientiousness will be assessed using the "The Big Five Inventor (BFI-10)".
Daily step count	Baseline to week 24	Steps will be measured using electronic devices such as wrist-worn activity trackers
Cardiac arrhythmia	Baseline to week 24	Cardiac arrhythmia will be measured using three-channel Holter ECG.
Submaximal exercise capacity	Baseline, week 3, and week 24	Submaximal exercise capacity will be measured using 6-min walking test
Habit formation	Baseline, week 3, week 24, and week 48	Habit formation will be assessed using validated questionnaire for the "Self-Report Behavioural Automaticity Index (SRBAI)".
Impact of disease	Baseline, week 3, week 24, and week 48	Impact of disease will be assessed using the "brief illness perception (IPQ-9)" questionnaire .
Depression	Baseline, week 3, week 24, and week 48	Depression will be assessed using the modified "Patient Health Questionnaire (PHQ-9)".
General anxiety	Baseline, week 3, week 24, and week 48	General anxiety will be assessed using the "7-item General Anxiety Scale (GAD-7)".
Optimism/ Pessimism	Baseline, week 3, week 24, and week 48	Optimism/ Pessimism will be assessed using the modified "Life Orientation Test (LOT-R)".
Psychological situation in the working environment	Baseline, week 3, week 24, and week 48	Psychological situation in the working environment will be assessed using the "The effort-reward imbalance model (ERI10+6)".
Work requirements and workload	Baseline, week 3, week 24, and week 48	Work requirements and workload will be assessed using the "Workability Index (WAI)".
Social support	Baseline, week 3, week 24, and week 48	Social support will be assessed using the short "Perceived Social Support Questionnaire (F-SozU K6)".
Nicotine dependence	Baseline, week 3, week 24, and week 48	Nicotine dependence will be assessed using the Fagerström questionnaire
Health-related quality of life	Baseline, week 3, week 24, and week 48	Health-related quality of life will be assessed using the "RAND 36-Item Health Survey (SF-36)".
General quality of life	Baseline, week 3, week 24, and week 48	Quality of life will be assessed using the "5-level EQ-5D (EQ-5D-5L) health status measure".
Psychological flexibility	Baseline, week 3, week 24, and week 48	Psychological flexibility will be assessed using the psychometric properties of the "Acceptance and Action Questionnaire-I (AAQ-II)".
Negative Affectivity	Baseline, week 3, week 24, and week 48	Standard assessment of negative affectivity, social inhibition, and Type D personality (DS-14)
Trait anger	Baseline, week 3, week 24, and week 48	Trait anger will be assessed using the "State-Trait Anger Expression Inventory-2 ("TAI-10/STAXI-2").
Religiousness/ spirituality	Baseline, week 3, week 24, and week 48	Religiousness/ spirituality will be assessed using the "Spiritual and Religious Attitudes in Dealing with Illness (GrAw-7/ SpREUK-15)" questionnaire.
Fatigue	Baseline, week 3, week 24, and week 48	Fatigue will be assessed using the "The Multidimensional Fatigue Inventory (MFI20)".
Relationship satisfaction	Baseline, week 3, week 24, and week 48	Relationship satisfaction will be assessed using the "Quality of Marriage Index (QMI)".

Trial Locations

Locations (1)

Klinik Königsfeld; 🇩🇪 Ennepetal, NRW, Germany