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

March 1, 2023 updated by: Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen Anhalt
      • Halle (Saale), Sachsen Anhalt, Germany, 06120
        • Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
    • Saint
      • Halle (Saale), Saint, Germany, 06110
        • St. Elisabeth and St. Barbara Hospital / Women's clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Investigators

  • Principal Investigator: Gregor Seliger, Dr. med., Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
  • Principal Investigator: Marcus Riemer, Dr. med., Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RedCarRisk-Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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