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临床试验/NCT02754778
NCT02754778已完成不适用

Evaluation of Practicability in Survey and Test Procedures and of Successful Implementation of Complex Interventions - Feasibility Analysis Based on a Pilot Study: Influence of Conditional Workout Postpartum on Arterial Stiffness Among Women With Status After Preeclampsia, Superimposed Preeclampsia or HELLP-syndrome

Martin-Luther-Universität Halle-Wittenberg2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
reduced aortic pulse wave velocity by 1m/s

研究概览

简要总结

Evaluation of practicability in survey and test procedures and of successful implementation of complex interventions - feasibility analysis based on a pilot study: Influence of conditional workout postpartum on arterial stiffness among women with status after preeclampsia, superimposed preeclampsia or HELLP-syndrome

详细描述

Cardiovascular disease is the main cause of death among women in Europe and in the USA. Its costs amount annually more than 196 billions Euro in Europe. The federal state of Saxony-Anhalt occupies leading position in mortality in myocardial infarction and coronary heart disease in Germany. Up to 8 percent of all pregnant women develop a severe pregnancy-associated hypertension, like preeclampsia, superimposed preeclampsia or HELLP-syndrome. These women have an increased lifetime risk for cardio- and cerebrovascular diseases.

The consecutive increasing arterial stiffness because of endothelial dysfunction is a determining factor in etiology of pregnancy-associated hypertension and results in increased cardiovascular risk. Aortal pulse wave velocity is used as Goldstandard for measuring arterial stiffness.

Pregnant women suffering from a severe pregnancy-associated hypertension present higher levels in arterial stiffness measured by pulse wave velocity than healthy pregnant women. Pathological changes of the vascular systems persistent from 6 month until 10 years after delivery and give an explanatory approach for an increased cardiovascular longterm risk at these patients. Numerous medical associations like American Heart Association aim at reducing especially cardiovascular longterm risk in women with status after preeclampsia, superimposed preeclampsia or HELLP syndrome.

Pregnancy-independent studies in patients with coronary heart disease and analysis in women with metabolic syndrome show a reduction of arterial stiffness by regular conditional workout.

Scientific problem of this pilot study: If a reduction in arterial stiffness in women from a risk group - during a 6-month-ongoing intensive regular conditional workout within a midwife-supported teamwork and under inclusion of dietary interventions - achieved?

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
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •diagnosis of preeclampsia, superimposed gestosis or HELLP syndrome
  • •capacity for content

排除标准

  • •eclamptic stroke
  • •New York Heart Association > Stadium II
  • •severe neurological or orthopedic disabilities
  • •peripheral arterial occlusive disease
  • •severe disease of the newborn which leads to an intensive familial care

研究组 & 干预措施

intervention group

Active Comparator

6 month of regular conditional workout 1-3 times a week

干预措施: conditional workout (Behavioral)

control group

No Intervention

no intervention, regular family life

结局指标

主要结局

reduced aortic pulse wave velocity by 1m/s

时间窗: six month

次要结局

  • no arterial hypertension defined as blood pressure ≤140mmHg / 80mmHg without antihypertensic medication(13 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregor Seliger

Dr. med. Gregor Seliger

Martin-Luther-Universität Halle-Wittenberg

研究点 (2)

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