PreeclampsiaNCT00900458
Exercise Induced Improvement of the Venous Reserve Capacity in Formerly Pre-eclamptic Women
A study testing Aerobic Exercise training in people with Preeclampsia, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Aerobic Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2009to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- pregnancy
- insulin dependant diabetes mellitus
- use of medication known to interfere with cardiovascular system
- incapability to cope with physical exercise
- auto immune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjustment of the Venous Reserve Capacity by Aerobic Exercise in Women at Increased Risk of Hypertensive Pregnancy Complications
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.
Read more
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.
Read the 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
- Conditions
- Preeclampsia
- Being tested
- Aerobic Exercise training
- Keywords
- preeclampsia, low vs high plasma volume
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise trainingBehavioural
aerobic exercise training (cycling)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | formerly preeclamptic women with low plasma volume Receives: Behavioral: Aerobic Exercise training |
| 2 | Active comparator | formerly preeclamptic women with normal plasma volume Receives: Behavioral: Aerobic Exercise training |
| 3 | Other | Healthy controls Receives: Behavioral: Aerobic Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase plasma volume
Measured: 3 months
Secondary outcomes (4)
Venous Compliance
Measured: 3 months
Endothelial dysfunction
Measured: 3 months
Sympathetic resting activity
Measured: 3 months
Splanchnic blood flow
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralph Scholten, Radboud University Medical Center
- Investigators
- Marc Spaanderman, Dr, Study chair, Radboud University Medical Center Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900458
- Sponsor's protocol ID
- exercise and pre-eclampsia
- Status last verified
- May 2015
- First submitted
- 11 May 2009
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Scholten RR, Hopman MT, Lotgering FK, Spaanderman ME. Aerobic Exercise Training in Formerly Preeclamptic Women: Effects on Venous Reserve. Hypertension. 2015 Nov;66(5):1058-65. doi: 10.1161/HYPERTENSIONAHA.115.05786. Epub 2015 Sep 8.
PubMed 26351026Scholten RR, Spaanderman ME, Green DJ, Hopman MT, Thijssen DH. Retrograde shear rate in formerly preeclamptic and healthy women before and after exercise training: relationship with endothelial function. Am J Physiol Heart Circ Physiol. 2014 Aug 1;307(3):H418-25. doi: 10.1152/ajpheart.00128.2014. Epub 2014 Jun 6.
PubMed 24906915Scholten RR, Thijssen DJ, Lotgering FK, Hopman MT, Spaanderman ME. Cardiovascular effects of aerobic exercise training in formerly preeclamptic women and healthy parous control subjects. Am J Obstet Gynecol. 2014 Nov;211(5):516.e1-516.e11. doi: 10.1016/j.ajog.2014.04.025. Epub 2014 Apr 23.
PubMed 24769012
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustment of the Venous Reserve Capacity by Aerobic Exercise in Women at Increased Risk of Hypertensive Pregnancy Complications
- ClinicalTrials.gov ID
- NCT00900458
- Acronym / sponsor ID
- exercise and pre-eclampsia
- Conditions
- Preeclampsia
- Keywords
- preeclampsia, low vs high plasma volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Aerobic Exercise trainingformerly preeclamptic women with low plasma volume |
| 2 | Active comparator | Behavioral: Aerobic Exercise trainingformerly preeclamptic women with normal plasma volume |
| 3 | Other | Behavioral: Aerobic Exercise trainingHealthy controls |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (5 listed)
- pregnancy
- insulin dependant diabetes mellitus
- use of medication known to interfere with cardiovascular system
- incapability to cope with physical exercise
- auto immune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise trainingaerobic exercise training (cycling) | Behavioural | 1, 2, 3 |
Primary outcome
Increase plasma volume
Time frame: 3 months
4 secondary outcomes
Venous Compliance
Time frame: 3 months
Endothelial dysfunction
Time frame: 3 months
Sympathetic resting activity
Time frame: 3 months
Splanchnic blood flow
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
- Derived from this study: PubMed 26351026Scholten RR, Hopman MT, Lotgering FK, Spaanderman ME. Aerobic Exercise Training in Formerly Preeclamptic Women: Effects on Venous Reserve. Hypertension. 2015 Nov;66(5):1058-65. doi: 10.1161/HYPERTENSIONAHA.115.05786. Epub 2015 Sep 8.
- Derived from this study: PubMed 24906915Scholten RR, Spaanderman ME, Green DJ, Hopman MT, Thijssen DH. Retrograde shear rate in formerly preeclamptic and healthy women before and after exercise training: relationship with endothelial function. Am J Physiol Heart Circ Physiol. 2014 Aug 1;307(3):H418-25. doi: 10.1152/ajpheart.00128.2014. Epub 2014 Jun 6.
- Derived from this study: PubMed 24769012Scholten RR, Thijssen DJ, Lotgering FK, Hopman MT, Spaanderman ME. Cardiovascular effects of aerobic exercise training in formerly preeclamptic women and healthy parous control subjects. Am J Obstet Gynecol. 2014 Nov;211(5):516.e1-516.e11. doi: 10.1016/j.ajog.2014.04.025. Epub 2014 Apr 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Spaanderman, Dr study chair
Radboud University Medical Center Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise training in people with Preeclampsia, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase plasma volume (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00900458, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2015.