TIMELY Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 612
- 试验地点
- 1
- 主要终点
- Change in Cardiorespiratory Fitness (CRF)
研究概览
简要总结
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:
- To examine uptake and adherence to a healthy lifestyle (i. e. adherence to CR guidelines in CAD) and the effects on long-term outcomes.
- To identify potentially mediating mechanisms and predictive factors for long-term CR success in CAD.
- To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Incapability to give informed consent
- •Conditions that prevent patients from participation in CR including unstable coronary or cerebrovascular conditions and acute infections
结局指标
主要结局
Change in Cardiorespiratory Fitness (CRF)
时间窗: 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)
时间窗: 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
时间窗: Baseline, week 3, and week 24
Risk of mortality will be determined using the validated biomarker risk score COROPREDICT
次要结局
- Resting heart rate(Baseline to week 24)
- Fear of Activity/ Kinesiophobia(Baseline, week 3, week 24, and week 48)
- Sleep duration(Baseline to week 24)
- Wellbeing(Baseline, week 3, week 24, and week 48)
- Physical activity (PA)(Baseline, week 3, week 24, and week 48)
- Weekly number and duration of physical activities(Baseline to week 24)
- Physiological stress(Baseline to week 24)
- Blood pressure(Baseline to week 24)
- Arterial pressure wave propagation/reflection characteristics(Baseline to week 24)
- Muscle strength(Baseline, week 3, and week 24)
- Body composition(Baseline, week 3, and week 24)
- Muscle function(Baseline, week 3, and week 24)
- Cardiac Self-Efficacy(Baseline, week 3, week 24, and week 48)
- General wellbeing(Baseline, week 3, week 24, and week 48)
- Perceived stress(Baseline, week 3, week 24, and week 48)
- Conscientiousness(Baseline, week 3, week 24, and week 48)
- Daily step count(Baseline to week 24)
- Cardiac arrhythmia(Baseline to week 24)
- Submaximal exercise capacity(Baseline, week 3, and week 24)
- Habit formation(Baseline, week 3, week 24, and week 48)
- Impact of disease(Baseline, week 3, week 24, and week 48)
- Depression(Baseline, week 3, week 24, and week 48)
- General anxiety(Baseline, week 3, week 24, and week 48)
- Optimism/ Pessimism(Baseline, week 3, week 24, and week 48)
- Psychological situation in the working environment(Baseline, week 3, week 24, and week 48)
- Work requirements and workload(Baseline, week 3, week 24, and week 48)
- Social support(Baseline, week 3, week 24, and week 48)
- Nicotine dependence(Baseline, week 3, week 24, and week 48)
- Health-related quality of life(Baseline, week 3, week 24, and week 48)
- General quality of life(Baseline, week 3, week 24, and week 48)
- Psychological flexibility(Baseline, week 3, week 24, and week 48)
- Negative Affectivity(Baseline, week 3, week 24, and week 48)
- Trait anger(Baseline, week 3, week 24, and week 48)
- Religiousness/ spirituality(Baseline, week 3, week 24, and week 48)
- Fatigue(Baseline, week 3, week 24, and week 48)
- Relationship satisfaction(Baseline, week 3, week 24, and week 48)
研究者
Dr. Boris Schmitz
Primary Researcher Department of Rehabilitation Sciences
University of Witten/Herdecke