Home-based Physical Trainings for Reducing Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- waist circumference (WC) navel
研究概览
简要总结
Prospective intervention study among metabolic syndrome patients, investigating the effects of 12 weeks home-based physical training programme with telemonitoring on the anthropometric parameters, the exercise tolerance and other cardio-metabolic risk factors of the metabolic syndrome.
详细描述
Prospective intervention study among metabolic syndrome patients, investigating the effects of 12 weeks home-based physical training programme with telemonitoring on the anthropometric and laboratory parameters, the exercise tolerance and other cardio-metabolic and other psycho-social (anxiety, depression, vital exhaustion , sleep disturbances) risk factors of the metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •voluntary patients aged between 25 and 70 years
- •low level of regular physical activity, less than 30 min./ week
- •basic IT skills
- •3 risk factors present out of the 5 metabolic risk factors from the followings:
- •waist circumference (WC) above 102 cm in men and above 88 cm in women
- •proved type 2 diabetes mellitus (T2DM) or fasting plasma glucose level above 5,6 mmol/l
- •treated hypertension or spontaneous blood pressure higher or equivalent than 130/ 85 mmHg
- •treated hypertriglyceridaemia or serum triglyceride level above 1,7 mmol/l
- •serum HDL cholesterol level under 1,03 mmol/l in men or 1,3 mmol/l in women
排除标准
- •any upcoming planned invasive cardiological intervention
- •uncontrolled hypertension
- •type one diabetes mellitus (T1DM)
- •T2DM which needed more than 1 dose insulin per day
- •chronic heart failure
- •chronic renal failure
- •serious cognitive disfunction
- •lack of cooperation
- •any of known disease or condition that seriously affect the mental and legal capacity
- •any other conditions inhibiting regular physical trainings
结局指标
主要结局
waist circumference (WC) navel
时间窗: 12 weeks
waist circumference measured at navel level
Six minutes walk distance (6MWD)
时间窗: 12 weeks
6 minutes walk distance
次要结局
- laboratory parameter 1(12 weeks)
- laboratory parameter 4(12 weeks)
- laboratory parameter 2(12 weeks)
- laboratory parameter 3(12 weeks)
- body parameter 2(12 weeks)
- body parameter 3(12 weeks)
- body parameter 4(12 weeks)
- body parameter 1(12 weeks)
- functional parameter 1(12 weeks)
- laboratory parameter 5(12 weeks)
- psychological test result 1(12 weeks)
- psychological test result 2(12 weeks)
- psychological test result 3(12 weeks)
- psychological test result 4(12 weeks)
- psychological test result 5(12 weeks)
- psychological test result 6(12 weeks)
研究者
István Kósa
Head of Department of Medical Prevention
Szeged University