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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00900458
First received: May 11, 2009
Last updated: August 10, 2011
Last verified: May 2009
  Purpose

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 Intervention
Preeclampsia
Behavioral: Aerobic Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Increase plasma volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Venous Compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Endothelial dysfunction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Sympathetic resting activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Splanchnic blood flow [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
3
Healthy controls
Behavioral: Aerobic Exercise training
aerobic exercise training (cycling)

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

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900458

Contacts
Contact: Ralph R Scholten, MSc +31 24 361 4906 r.scholten@obgyn.umcn.nl
Contact: Marc Spaanderman, Dr. + 31 24 361 7831 m.spaanderman@obgyn.umcn.nl

Locations
Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Netherlands, 6500HB
Contact: Ralph Scholten, MSc    +31 24 36 14906    r.scholten@obgyn.umcn.nl   
Sponsors and Collaborators
Radboud University
Investigators
Study Chair: Marc Spaanderman, Dr Radboud University Medical Center Nijmegen
  More Information

No publications provided

Responsible Party: dr.M.E.A. Spaanderman/ drs.R.R. Scholten, Radboud University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT00900458     History of Changes
Other Study ID Numbers: exercise and pre-eclampsia
Study First Received: May 11, 2009
Last Updated: August 10, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
preeclampsia
low vs high plasma volume

Additional relevant MeSH terms:
Pre-Eclampsia
Pregnancy Complications
Hypertension, Pregnancy-Induced

ClinicalTrials.gov processed this record on August 20, 2014