Clinical trial NCT02754778: Influence of Conditional Workout Postpartum on Arterial Stiffness Among Women With Status After Preeclampsia, Superimposed Preeclampsia or HELLP-syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Superimposed Preeclampsia
HELLP Syndrome
Keywords: arterial stiffness
preeclampsia
HELLP-syndrome
pulse wave velocity
advanced glycation endproducts
skin autofluorescence
conditional workout
postpartum
cardiovascular risk
pregnancy
vicorder
age reader
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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?

Eligibility criteria: 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

Primary outcomes:
measure: reduced aortic pulse wave velocity by 1m/s
timeFrame: six month
Secondary outcomes:
measure: no arterial hypertension defined as blood pressure ≤140mmHg / 80mmHg without antihypertensic medication
timeFrame: 13 years
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
state: Sachsen Anhalt
city: Halle (Saale)
country: Germany
facility: St. Elisabeth and St. Barbara Hospital / Women's clinic
state: Saint
Study officials:
affiliation: Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
name: Marcus Riemer, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
name: Gregor Seliger, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: