"Hjerteloeftet". Early Interventions to Promote Physical Activity, Dietary Lifestyle Changes and Optimal Medication for Cardiovascular Risk Factor Reduction in Over 3 Years Follow-up.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 701
- 试验地点
- 1
- 主要终点
- Change in risk score (NORRISK)
研究概览
简要总结
Early interventions to promote physical activity, dietary lifestyle changes and optimal medication for cardiovascular risk factor reduction - 3 years follow-up. A randomized Clinical Trial.
详细描述
Background
It has been established that the major risk factors of coronary artery disease are modifiable risk factors. The international Case control study across 52 countries has identified that 90% of the risk of acute myocardial infarction in males and 94% in females were modifiable risk factors as smoking habits, presence of hypertension, diabetes mellitus, abdominal obesity, psychological and social stress and hyperlipidemia (1).
It is well established that interventions to promote physical activity and dietary changes could have beneficial effect in the reduction of incidence of coronary heart disease (CHD) (2).
Aim of the Study
The research hypothesis is that for persons on medium to high risk of CHD an early intervention using lifestyle and drugs over a period of three years can reduce the patients risk to develop CHD as estimated by risk score and some established risk factors of CHD as secondary surrogate end points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All male and female between the age of 35 to 67 with middle or high 10 years risk estimate are included.
- •>= 0.5% for persons under the age of 50 years
- •>= 2.5% for persons between 50-59 years
- •>= 5% for persons > 60 years
排除标准
- •Previous cardiovascular disease (CHD ; peripherical atherosclerosis, deep venous thrombosis /pulmonary embolism, congenital heart disease, presence of valvular heart disease).
- •Lung disease restricting usual physical activity .
- •Serious psychological problems (that hinders the participation in the study)
- •All kind of disease restricting performing adequate physical activity .
- •Presence of cancer shortening drastically survival.
研究组 & 干预措施
Intervention (INT1)
The participants will join a 5-days course at the Feiring Heart Clinic.
干预措施: Intervention (INT1) (Behavioral)
Control (KTR1)
The participants in the Control Group will receive care as usual at their local Doctors Office
Subgroup Intervention (INT2)
Subgroup of 200 participants from the (INT1)where multiple, known CVD risk factors are studied: Physical Activity, Physical Condition (O2-consumption), Quality of life, Biochemical markers (fasting Glucose, Insulin, Apo Lipoprotein A (ApoA), Apo Lipoprotein B (ApoB), micro-C reactive protein (CRP), Total-, LDL- and HDL-cholesterol, Triglycerides and HbA1C.
干预措施: Intervention (INT1) (Behavioral)
Subgroup control (KTR2)
Subgroup of 200 participants from the (KTR1)where multiple, known CVD risk factors are studied: Physical Activity, Physical Condition (O2-consumption), Quality of life, Biochemical markers (fasting Glucose, Insulin, Apo Lipoprotein A (ApoA), Apo Lipoprotein B (ApoB), micro-C reactive protein (CRP), Total-, LDL- and HDL-cholesterol, Triglycerides and HbA1C.
结局指标
主要结局
Change in risk score (NORRISK)
时间窗: 3 Years after end of inclusion
Major End Point Change in risk score (Norrisk, Procam and Framingham) between baseline and after three years of intervention.
次要结局
- Weight and Body Mass Index (BMI)(3 Years after end of inclusion)
- Waist circumference(3 Years after end of inclusion)
- Serum Lipids(3 Years after end of inclusion)
- Blood Pressure(3 Years after end of inclusion)
- HbA1C(3 Years after end of inclusion)