A 6-months Lifestyle Intervention With Interval and Resistance Exercise in Patients With Coronary Artery Disease and Diabetes Mellitus in a Community Based Setting
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in VO2peak in ml/kg/min
研究概览
简要总结
Regular exercise training has shown to improve exercise capacity in patients with cardiovascular disease. The feasibility and transferability of exercise training in a community based cardiovascular rehabilitation setting is currently less well investigated. The objective of this study is to translate regular exercise training into a community based setting. A 6 months training intervention program with lifestyle counseling is performed, with both supervised training in rehabilitation centres as well as home based training. The aim of the project is to implement this program for a wider patient population and to improve exercise capacity, diastolic function as well as cardiometabolic parameters.
详细描述
From 2011, patients insured at "Techniker" health insurance company with diagnosed coronary heart disease, heart failure and/or diabetes mellitus are being included in a 6-months training program. Training is performed 3 times weekly for 6 weeks, then twice weekly for another 6 weeks, while patients are asked to do home based training. The last phase of 12 weeks, supervised training is only once/week. Patients are asked to perform exercise training 3-5 times weekly. At the beginning as well as after 3 and 6 months, patients present for medical check-up with cardiorespiratory exercise testing from which training instructions are drawn. Training-intensity begins with moderate continuous training and switches to higher intensity interval training after 6 weeks. Resistance training starts after 6 weeks and is performed within the supervised training. All patients were offered an individual nutritional counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary artery disease and/or diabetes mellitus
- •Heart failure
排除标准
- •all conditions which are not compatible with exercise training:
- •severe orthopedic disorders
- •severe psychiatric disease
- •severe valve insufficiency
- •presence of myocardial ischemia (decision made by cardiologist)
研究组 & 干预措施
Exercise training
All patients were included in the exercise training group
干预措施: Exercise training (Behavioral)
结局指标
主要结局
Change in VO2peak in ml/kg/min
时间窗: 6 months
Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention
次要结局
- Change in insulin IU(6 months)
- Change in Adiponectin(6 months)
- Change in max. Watts/kg bodyweight(6 months)
- Change in HbA1c for patients with diabetes(6 months)
- Change in E/e'(6 months)
- Change in quality of life measured by SF-36(6 months)
- Change in Watts at anaerobic threshold RCP(6 months)
- Change in hsCRP(6 months)
- Change in HDL- and LDL- cholesterol as well as triglycerides(6 months)
- Change in Watts at anaerobic threshold VAT(6 months)
- Change in max. Watts(6 months)
研究者
Jeffrey W Christle
Principal investigator
Technical University of Munich