Influence of Conditional Workout Postpartum on Arterial Stiffness Among Women With Status After Preeclampsia, Superimposed Preeclampsia or HELLP-syndrome (RedCarRisk)
Primary Purpose
Preeclampsia, Superimposed Preeclampsia, HELLP Syndrome
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
conditional workout
Sponsored by
About this trial
This is an interventional prevention trial for Preeclampsia focused on measuring arterial stiffness, preeclampsia, HELLP-syndrome, pulse wave velocity, advanced glycation endproducts, skin autofluorescence, conditional workout, postpartum, cardiovascular risk, pregnancy, vicorder, age reader
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
Sites / Locations
- Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
- St. Elisabeth and St. Barbara Hospital / Women's clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
control group
intervention group
Arm Description
no intervention, regular family life
6 month of regular conditional workout 1-3 times a week
Outcomes
Primary Outcome Measures
reduced aortic pulse wave velocity by 1m/s
Secondary Outcome Measures
no arterial hypertension defined as blood pressure ≤140mmHg / 80mmHg without antihypertensic medication
Full Information
NCT ID
NCT02754778
First Posted
April 22, 2016
Last Updated
March 1, 2023
Sponsor
Martin-Luther-Universität Halle-Wittenberg
1. Study Identification
Unique Protocol Identification Number
NCT02754778
Brief Title
Influence of Conditional Workout Postpartum on Arterial Stiffness Among Women With Status After Preeclampsia, Superimposed Preeclampsia or HELLP-syndrome
Acronym
RedCarRisk
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
March 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
no intervention, regular family life
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
6 month of regular conditional workout 1-3 times a week
Intervention Type
Behavioral
Intervention Name(s)
conditional workout
Intervention Description
6 month of regular conditional workout 1-3 times a weak
Primary Outcome Measure Information:
Title
reduced aortic pulse wave velocity by 1m/s
Time Frame
six month
Secondary Outcome Measure Information:
Title
no arterial hypertension defined as blood pressure ≤140mmHg / 80mmHg without antihypertensic medication
Time Frame
13 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Riemer, Dr. med.
Organizational Affiliation
Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregor Seliger, Dr. med.
Organizational Affiliation
Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
City
Halle (Saale)
State/Province
Sachsen Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
St. Elisabeth and St. Barbara Hospital / Women's clinic
City
Halle (Saale)
State/Province
Saint
ZIP/Postal Code
06110
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.thieme-connect.com/products/ejournals/html/10.1055/a-1345-8733?articleLanguage=en
Description
Paper
Learn more about this trial
Influence of Conditional Workout Postpartum on Arterial Stiffness Among Women With Status After Preeclampsia, Superimposed Preeclampsia or HELLP-syndrome
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