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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect During Pregnancy and Intrapartum Health

NCT03348332

Pregnancy

COMPLETED NA

Physical Activity and Sedentary Lifestyle During Pregnancy: Feasibility and Impact Study on Sedentary Behavior

NCT05225376

Sedentary Behavior Pregnancy Related Perinatal Problems +2 more

COMPLETED NA

Exercise Induced Improvement of the Venous Reserve Capacity in Formerly Pre-eclamptic Women

NCT00900458

Preeclampsia

COMPLETED NA

Acute Exercise Effects in Obese Pregnancy

NCT03750695

Pregnancy Complications Obesity Pre-Eclampsia +1 more

COMPLETED NA

Effect of Hypopressive Exercises on Postpartum Backache and Functional Disability

NCT06259474

Low Back Pain

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preeclampsia Superimposed Preeclampsia HELLP Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

no intervention, regular family life

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention group

6 month of regular conditional workout 1-3 times a week

Group Type ACTIVE_COMPARATOR

conditional workout

Intervention Type BEHAVIORAL

6 month of regular conditional workout 1-3 times a weak

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

conditional workout

6 month of regular conditional workout 1-3 times a weak

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No