Influence of Conditional Workout Postpartum on Arterial Stiffness Among Women With Status After Preeclampsia, Superimposed Preeclampsia or HELLP-syndrome

Study Overview
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Brief Summary
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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

Detailed Description
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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?

Official Title
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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

Conditions
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Preeclampsia, Superimposed Preeclampsia, HELLP Syndrome

Intervention / Treatment
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* Behavioral: conditional workout


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of preeclampsia, superimposed gestosis or HELLP syndrome capacity for content Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>no intervention, regular family life | |
| Active Comparator: intervention group<br>6 month of regular conditional workout 1-3 times a week | Behavioral: conditional workout<br>* 6 month of regular conditional workout 1-3 times a weak<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduced aortic pulse wave velocity by 1m/s |  | six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no arterial hypertension defined as blood pressure ≤140mmHg / 80mmHg without antihypertensic medication |  | 13 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arterial stiffness, preeclampsia, HELLP-syndrome, pulse wave velocity, advanced glycation endproducts, skin autofluorescence, conditional workout, postpartum, cardiovascular risk, pregnancy, vicorder, age reader