Effect of Personal and IT Based Training to Performance, Metabolic Profil and Quality of Life by Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Evaluation of the effect of a combined personal and IT- based training on the performance at the metabolic anaerobe barrier of patients with impending or manifest metabolic syndrome compared to a control group with conventional consulting
研究概览
简要总结
Prospective, randomized, single center, controlled intervention study to investigate the effect of a systematic combined personal and IT-based training on the outcome of patients with metabolic syndrome.
详细描述
The study settles in the field of primary prevention and aims to change lifestyle of patients with metabolic syndrome with a new combination of personal and IT-based training specially designed für obese people with risk factors. Procedures that are similar for all participants are summarized in a training program whereas individual aspects of physical activity like initial education and exercise tests are still performed by doctors and trainers. Before and after three months of training anthropometric parameters, laboratory and exercise capacity are examined and analyzed. The intervention group is characterized by a predetermined exercise program whereas the control group is allowed to practise without detailed instructions. The practicability and the effect on health status of the combined personal and IT-based training in the intervention group is compared with the independent training of the control group. After 6 months and again after 12 months the measurements are repeated to evaluate a lasting effect of the program.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males and females between 20 and 60 years
- •Staff of the Fa. BMW
- •written informed consent after detailed education
- •BMI 25-35 kg/m2
- •≤ 1x/week sport respectively exercise
- •metabolic syndrome (at least 3 of 5 criteria)
排除标准
- •> 1x/week physical activity
- •BMI < 25 kg/m2 or > 35 kg/m2
- •Florid acute or chronic disease of any kind prohibiting regular physical activity
- •Diabetes mellitus
- •pregnancy or lactation
- •Drug or alcohol abuse
结局指标
主要结局
Evaluation of the effect of a combined personal and IT- based training on the performance at the metabolic anaerobe barrier of patients with impending or manifest metabolic syndrome compared to a control group with conventional consulting
时间窗: 12 months
次要结局
- Evaluation of the effect of IT based training on metabolic parameters(12 months)
- Evaluation of the efficacy of IT based training to an increase of activity by patients with impending or manifest metabolic syndrome(12 months)
- Change in quality of life and subjective assumption of health sensation(12 months)
- Change in anthropometric parameters(12 months)
- Raise of maximum performance (max. ergometric performance)(12 months)