Psychodynamic Motivation and Training Program (PMT) as Secondary Prevention in Patients With Stable Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in individual anaerobic threshold according to lactate kinetics during spiroergometry
研究概览
简要总结
The purpose of this study is to examine the effectiveness of a Psychodynamic Motivation and Training Program (PMT) for the improvement of physical fitness in patients with stable coronary heart disease as compared to advice in exercise training or treatment as usual.
详细描述
Nonpharmacological secondary prevention of coronary heart disease is considered to be a safe and effective measure for reducing mortality substantially. Major targets are the improvement of physical activity and dietary habits, smoking cessation and stress reduction. Despite the effectiveness of life style changes, the compliance rate of patients is very low. To improve compliance with life style change programs psychotherapeutic interventions appear to have significant potential. Against this background our study aims to examine the effectiveness of a Psychodynamic Motivation and Training Program (PMT) in addition to one session of advice in exercise training based on the results of spiroergometry (+EX) and usual cardiological care (TAU). PMT will be compared with +Ex and TAU. N = 90 patients with stable coronary artery disease class, low physical activity, class I to III angina pectoris will be randomly assigned to the three treatment conditions. The Primary efficacy endpoint is change in the anaerobic threshold from baseline to 6 month follow-up. The results of the study will 1) help to determine the effectiveness of a psychodynamic life style change programs for the secondary prevention of cardiovascular disease and 2) will help to identify measures for designing specifically tailored interventions to improve compliance with cardiovascular prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable coronary heart disease with CCS functional classification of angina class I-III
- •Low self rated physical activity
- •Condition after percutaneous coronary intervention > 4 weeks until < 26 weeks or > 52 weeks after index percutaneous coronary intervention
- •Residence < 50 km radius of Mainz
- •If treatment with betablockers or ivabradine then stable > 4 weeks
排除标准
- •Acute coronary sydnrome or myocardial infarction < 8 weeks
- •Coronary stenosis of the dominant vessel > 25% or high grade stenosis of the left coronary artery
- •Heart failure with left ventricular ejection fraction < 40%
- •NYHA III-IV
- •Severe heart valve disorder
- •Insulin dependent diabetes
- •Orthopedic disorders or other disorders, which preclude regular physical activity
- •Coronary artery bypass surgery < 6 months before index PCI
- •Severe obesity (BMI ≥ 40)
- •Need for systemic immunosuppression with cortisone or methotrexate
- •Kidney failure with need for dialysis
- •Intake of nitrates < 12 hours
结局指标
主要结局
Change in individual anaerobic threshold according to lactate kinetics during spiroergometry
时间窗: 6 months
次要结局
- Change in illness perception(6 months)
- Change in maximal aerobic capacity (VO2 max)(6 months)
- Change in the severity of impairment by angina symptoms according to the Seattle Angina Questionnaire(6 Months)
- Change in the self-rated habitual physical activity according to the Habitual Physical Activity Questionnaire(6 months)
- Change in endothelial function according to the flow mediated dilatation(6 months)
- Change in high density lipoprotein levels(6 months)
- Change in biomarkers of inflammation and oxidative burst(6 months)
- Change in body mass index(6 months)
- Change in quality of life according to the EQ-5D(6 months)
- Change in fatigue according to the Maastricht Questionnaire(6 months)
研究者
Matthias Michal
PD Dr. med.
Johannes Gutenberg University Mainz