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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00900458
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 7, 2015
Information provided by (Responsible Party):
Ralph Scholten, Radboud University

Brief Summary:

Primary objective:

  • To investigate whether physical exercise prior to pregnancy in formerly preeclamptic women results in a comparable improvement of vascular and endothelial functioning as in women who had an uneventful pregnancy.

Secondary objectives:

  • Which cardiovascular and endothelial parameters are involved in the vascular adaptation to training in women with a history of preeclampsia.
  • To study the vascular adaptation in the (next) pregnancy in women with a history of preeclampsia compared with women with a history of an uncomplicated pregnancy, after improvement of their physical condition by exercise training.

This study is important in order to get a better understanding of the vascular and endothelial factors involved in preeclampsia and the effects of training on this profile. Results of this study can contribute to the improvement of preventing hypertensive complications in pregnancy and reduction of life time risk of cardiovascular disease in formerly preeclamptic women.

Condition or disease Intervention/treatment Phase
Preeclampsia Behavioral: Aerobic Exercise training Not Applicable

Detailed Description:

In the Netherlands almost 15.000 women each year develop hypertensive complications like preeclampsia during their first pregnancy. In the western world these complications account for the most substantial attribution to neonatal and maternal morbidity and mortality. The exact etiology of this disease cascade is still unknown. There is accumulating evidence that subclinical abnormalities and preexistent haemodynamic, haemostatic and endothelial factors are involved, and thought to have negative impact on placental and endothelial functioning. The same factors are found to be risk factors for cardiovascular incidents and therefore it is not surprising that remotely these women are more at risk for hypertension, cardiovascular disease and stroke. Plasma volume has possibly a central role in the disease cascade, resulting in decreased cardiovascular reserve capacity. Furthermore a low plasma volume is found to be a strong predictor for recurrence of hypertensive complicated pregnancy. Adaptation, like in pregnancy, is for a large extent depending on the functioning of the venous compartment. In formerly preeclamptic women with low plasma volume is the venous compliance and capacitance decreased, furthermore there is sympathic hyperactivity. This combination reflects a decreased cardiovascular reserve capacity. These women with low plasma volume show a reduced ability to adapt their cardiovascular system to a new pregnancy.

It is known that physical exercise increases plasma volume in healthy adults, also arterial and both venous compliance and capacitance is improved by exercise. Since abnormal circulatory functions are common in formerly preeclamptic women, we want to study the effects of exercise in this specific group, and compare these results with women after an uneventful pregnancy. In preventive perspective it would be beneficial that also formerly preeclamptic women show a circulatory adaption to aerobic exercise, possibly they could improve their haemodynamic profile prior to their pregnancy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Adjustment of the Venous Reserve Capacity by Aerobic Exercise in Women at Increased Risk of Hypertensive Pregnancy Complications
Study Start Date : March 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
formerly preeclamptic women with low plasma volume
Behavioral: Aerobic Exercise training
aerobic exercise training (cycling)

Active Comparator: 2
formerly preeclamptic women with normal plasma volume
Behavioral: Aerobic Exercise training
aerobic exercise training (cycling)

Healthy controls
Behavioral: Aerobic Exercise training
aerobic exercise training (cycling)

Primary Outcome Measures :
  1. Increase plasma volume [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Venous Compliance [ Time Frame: 3 months ]
  2. Endothelial dysfunction [ Time Frame: 3 months ]
  3. Sympathetic resting activity [ Time Frame: 3 months ]
  4. Splanchnic blood flow [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • patients: formerly preeclamptic women with history of preeclampsia (according to set criteria)
  • controls: women with history of an uneventful pregnancy All women are examined at least 5 months postpartum;

Exclusion Criteria:

  • pregnancy
  • insulin dependant diabetes mellitus
  • use of medication known to interfere with cardiovascular system
  • incapability to cope with physical exercise
  • auto immune disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00900458

Radboud University Medical Center
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Study Chair: Marc Spaanderman, Dr Radboud University Medical Center Nijmegen