Role of Combined Intervention of Physical Activity and Nutrition in Metabolic Syndrome Treatment on Cardio-vascular Risk and Muscular- Skeletal Functions in Human Subject. Analysis of Patient's Compliance in Patient's Follow-up.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Decreased abdominal fat mass, measured after one year. Such measured will be done repetitively at Day 0, 21 and at 3, 6 and 12 months using abdominal circumference and DXA Decreased cardio-vascular risks
研究概览
简要总结
Metabolic syndrome has been defined as a group of associated risk factors for cardio-vascular diseases and diabetes. It is usually treated with an association of restrictive diet, physical exercise and drugs. Nevertheless the type of exercise associated to reduction in cardio-vascular risks is not yet fully defined. Long term effects of such hygienic-diet programs are of great importance since it is well-known that compliance to such treatment are of short duration, namely when subjects return in routine life. Metabolic syndrome volunteer subjects (n=90), aged 50 to 70 yrs will be randomly assigned to 3 groups of investigation.One group will perform mostly resistance activity, a second mainly endurance activity and the third one will be composed of subjects not exercising a lot. All subjects will have the same restrictive diet (500-700 kcal/d) After the initial training (3 weeks), they will return home with diet and physical program advises (personal compliance). They will be followed for one year (at 3, 6 and 12 months) Such a design may allow to find out the type of activity and power that are the best to reduce metabolic syndrome parameters and cardio-vascular risk factors.
The primary outcome variable is the reduction in abdominal circumference, which is the main criteria of MS.
详细描述
The protocol is designed to determine which type of physical activity is the best to reduce metabolic syndrome parameters especially abdominal circumference.
90 Metabolic syndrome (MS) Patients will be recruited by advertising and checked for MS criteria. They will have a VO2max test in order to be sure they can perform physical activities safely. After being checked, patients will have an eight day period to think about participation and to ask questions before signing consent. They have to feel 3 questionnaires, one about regular physical activities, one about food intakes and a psychology one to measure reluctance to the program. After written informed consent obtained, patients will be randomly assigned to one of 3 groups of physical activity Group 1 will perform mostly resistance activities, group 2 mostly endurance activities, and group 3 performing both activities at low level, serves as a control group for physical activities and also to determine the importance of food reduction and food equilibrium in the treatment.
All subjects will have the same restrictive diet (500- 700 kcal/d). They will be followed for one year (at 3, 6 and 12 month), continuing at home the same program (diet and exercise training).
30 healthy subjects will be recruited for cross-sectional comparison (They will not follow any intervention, but will have the same investigation, only once).
Measured parameters Before and after the 3-week program and at 3, 6 and 12 months, the following measurements will be made Level of physical activities quantifying heart rate in each activity during the training 3 weeks and estimated thereafter on the same parameter.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50-70 years old from both sexes
- •with metabolic syndrome
- •affiliated to a social security system
- •able to practice maximal physical exercises based on VO2 max
- •able to sign inform consent
排除标准
- •recent (6 month) major health conditions and patients with recurrent health problems (1 per year)
- •patients who are not capable to perform VO2 max without abnormalities
- •dyserection treated patients
- •patients with insufficient comprehensive ability to feel questionnaire and/or to change habits
结局指标
主要结局
Decreased abdominal fat mass, measured after one year. Such measured will be done repetitively at Day 0, 21 and at 3, 6 and 12 months using abdominal circumference and DXA Decreased cardio-vascular risks
时间窗: at Day 0, 21 and at 3, 6 and 12 months using abdominal circumference and DXA
次要结局
- All the following measures will be done at day 0, 21 and at month 3, 6 and 12. Level of physical activities of each types Physical performances, Food intake and equilibrium Other Metabolic Syndrome inc(at day 0, 21 and at month 3, 6 and 12.)