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

M

Martin-Luther-Universität Halle-Wittenberg

Status

Completed

Conditions

Preeclampsia
Superimposed Preeclampsia
HELLP Syndrome

Treatments

Behavioral: conditional workout

Study type

Interventional

Funder types

Other

Identifiers

NCT02754778
RedCarRisk-Study

Details and patient eligibility

About

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

Full 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?

Enrollment

40 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

control group
No Intervention group
Description:
no intervention, regular family life
intervention group
Active Comparator group
Description:
6 month of regular conditional workout 1-3 times a week
Treatment:
Behavioral: conditional workout

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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