Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 11
- 主要终点
- Change in HbA1c
研究概览
简要总结
Chronic ischemic heart disease and diabetes mellitus type II have one of the highest morbidity and mortality rates. Especially in the presence of both diseases, these risks increase exponentially. The aim of this program is to reduce cardiovascular risk factors by promoting individual health literacy and a healthy lifestyle, thereby improving metabolism and reducing the progress of the disease as well as mortality.
Patients will receive individual exercise prescriptions and nutritional recommendations. This lifestyle intervention is accompanied by step counters, heart rate sensors, blood glucose meters and smartphones to allow regional implementation in different areas in Germany. In total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease will participate in the trial.
The project examines whether the intervention positively affects metabolic health and lifestyle behaviors, increases health literacy, and reduces cardiovascular events of these high risk patients. Furthermore, the effectiveness of the intervention will be compared between urban and rural areas.
详细描述
Chronic ischemic heart disease and diabetes mellitus type II have one of the highest morbidity and mortality rates. Especially in the presence of both diseases, these risks increase exponentially. The combined endpoint of death and myocardial infarction reaches up to 30% within four years. A lifestyle intervention with exercise training and dietary change can reduce the mortality by 20-30% and is a class-I indication in the current guidelines of the European Association of Preventive Cardiology (EAPC). Nevertheless, the implementation of lifestyle interventions in the population is insufficient.
This prospective randomized controlled trial examines whether a structured, individual and telemedicine-supported lifestyle intervention improves health literacy and reduces cardiovascular risk factors compared to a guideline-based recommendation (usual care). Furthermore, the effectiveness of the intervention will be compared between urban and rural areas.
In total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease will participate in the trial. After randomization (1:1), the 750 patients of the intervention group will receive individual exercise prescriptions and nutritional recommendations based on a maximum exercise stress test and a multi-day nutrition protocol. The intervention is accompanied by pedometers, heart rate sensors, blood glucose meters and smartphones as well as regular oral and written feedback.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic heart disease (ICD-10: I20-I25)
- •Diabetes mellitus heart disease (ICD-10: E11)
- •insured at participating health insurance
- •permission to exercise by the study investigator
- •written informed consent
排除标准
- •Mental and behavioral disorders (ICD-10: F0-F99)
- •Heart failure NYHA IV (ICD-10: I50.14)
- •Malignant neoplasm (ICD-10: C25, C34, C56, C72, C73, C78, C79, C97)
- •Parkinson's disease (ICD-10: G20)
- •Alzheimer's disease (ICD-10: G30)
- •infantile cerebral palsy (ICD-10: G80)
- •chronic kidney disease (ICD-10: N18.4 & N18.5)
- •Trisomy 21 (ICD-10: Q90)
- •Blindness / visual impairment (ICD-10: H54.0, H54.2, H54.3)
- •Hearing loss (ICD-10: H90.0, H90.3, H90.5, H90.6, H90.8)
- •Care level 1-5
- •Assured in a foreign country
- •Inability to exercise or conditions that may interfere with exercise intervention
- •No optimal medical treatment within the last 4 weeks
- •Not clinically stable within the last 4 weeks
- •Participation in another clinical trial
结局指标
主要结局
Change in HbA1c
时间窗: 6 months
measured in percent (%)
次要结局
- Change in HbA1c(12 months)
- Change in health literacy(6 and 12 months)
- Change in average steps per day(6 and 12 months)
- Change in quality of life(6 and 12 months)
- Change in LDL-cholesterol concentrations(6 and 12 months)
- Number of the combined endpoint "4P-MACE"(6 and 12 months)
- Change in daily physical activity(6 and 12 months)
- Change in eating behavior(6 and 12 months)
- Change in triglyceride concentrations(6 and 12 months)
- Change of medical care expenses(6 and 12 months)
- Change in weight(6 and 12 months)
- Change in waist circumference(6 and 12 months)
- Change in HDL-cholesterol concentrations(6 and 12 months)
- Change in systolic blood pressure(6 and 12 months)
- Change in diastolic blood pressure(6 and 12 months)
研究者
Prof. Dr. med. Martin Halle
Univ.-Prof. Dr. med.
Technical University of Munich