PreeclampsiaSOSNCT06402604
Stress Reduction in Formerly Preeclamptic Women; Sofa or Sports
A study testing Aerobic exercise training and Mindfulness Based Stress Reduction training in people with Preeclampsia and Stress, Psychological, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
The goal of this clinical trial is to evaluate stress and cardiovascular risk factors in women with preeclampsia in the medical history. The main questions it aims to answer are: to improve our understanding of the underlying psychological and physical stress factors in relation to the circulatory risk profile in… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Stress, Psychological, Stress, Physiological
- What is being tested?
- Aerobic exercise training and Mindfulness Based Stress Reduction training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Apr 2022to 23 Sep 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent given
- Age > or = 18 years
- Good understanding of Dutch language
- Preeclampsia in prior pregnancy, defined as the combination of gestational hypertension (≥140/90 mmHg, measured twice, six hours or more apart), and proteinuria (consistently ≥300mg/24 hours) after 20 weeks of pregnancy in previously normotensive women, according to International Society for the Study of Hypertension in Pregnancy (Brown, 2018).
- Normotensive at the time of baseline measurements
- Perceived Stress Scale score ≥ 16 or State-Trait Anxiety Inventory (STAI) score ≥ 41 or Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10
Who cannot join
- Pre-existent diabetes mellitus, autoimmune disease, HIV positivity or overt cardio-vascular disease.
- Use of medication or supplements that might affect the cardiovascular system
- (Physical) inabilities to complete 12 weeks of moderate exercise training
- Currently involved in psychological therapy or mindfullness training.
- Pregnancy
- Women who intend to become pregnant within 12 weeks after baseline assessment
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Maastricht UMC+
Maastricht, Limburg, 6202AZ
Joris J.A. van Esch
Nijmegen, Gelderland, 6500HB
About this study
The goal of this clinical trial is to evaluate stress and cardiovascular risk factors in women with preeclampsia in the medical history. The main questions it aims to answer are:
- to improve our understanding of the underlying psychological and physical stress factors in relation to the circulatory risk profile in women with a history of preeclampsia
- to examine the effects of mindfullness based stress reduction (MBSR) or aerobic exercise training on hair cortisol and symptoms of mental stress.
Participants will undergo pre- and post-intervention pre-conceptional standard cardiovascular assessments, head tilt test and give a hair sample. As intervention they will sport or do mindfulness for 3 months.They will be compared with a control group.
Read the detailed description
Rationale: Approximately one out of three women with pre-term preeclampsia develops a post-traumatic stress disorder or depression after pregnancy. This could be related to the psychological impact of preeclampsia and premature birth resulting in increased perceived stress. It is also possible that preeclampsia and stress levels share a common aetiology, as both appear to correlate with increased cortisol levels and higher sympathetic drive. Approximately 50% of women with a history of preeclampsia have low plasma volume levels, indicating reduced circulatory reserve. Women with a hemodynamic profile characterized by a limited circulatory reserve have increased resting sympathetic tone, and are prone to develop preeclampsia in a subsequent pregnancy. These women also report more complaints of perceived stress. This raises not only the question whether increased perceived stress in women with a history of preeclampsia originates within the brain itself (primary psychological) or whether it is a psychological reflection of underlying reduced circulatory reserves (secondary psychological), but also the question about which intervention is most effective to reduce this perceived stress level. Should the investigators focus more on the emotional coping mechanisms and psychological aspects or should the investigators aim at improving the underlying hemodynamic profile and circulatory reserves to reduce overall sympathetic drive? The investigators hypothesize that 1) both interventions in women with preeclampsia and increased mental stress complaints will result in improved circulatory reserve, lower cortisol levels, lower sympathetic resting tone, and better continuous physiological measures (as measured with a smartwatch during the trial). 2) The aerobic exercise training will additionally improve the women's cardiovascular risk profile.
Objective: To investigate the effects of online mindfulness-based stress reduction (MBSR) therapy and aerobe exercise training on mental stress, physiological stress (hair cortisol) and cardiovascular risk profile in women with a history of preeclampsia and current increased symptoms of mental stress.
Study design: Multicenter randomized trial of two interventions (online mindfulness therapy and aerobic exercise training) and a time control group who undergo neither of the two interventions (wait list group). Possible eligible women will be recruited in two tertiary hospitals (Radboudumc Nijmegen and Maastricht Medical Centre) after referral to these centres for preconceptional cardiovascular assessment after severe preeclampsia in a previous pregnancy. Participants with symptoms of mental stress will be randomly assigned to either one of the two intervention groups or the wait list (3 options) after the Preconceptional Cardiovascular Assessment (PcCA) and Stress Assessment (SA). After 12 weeks of intervention, or in the case of the wait list group, 12 weeks without intervention, another PcCA and SA will take place. Results after 12 weeks will be compared with baseline results. Additionally, in all groups online questionnaires will be filled in 6 months after baseline assessments. Women who were allocated to the wait list group are offered either mindfulness therapy or aerobic exercise training after completing the second PcCA and SA after 12 weeks.
Study population: Primiparous women with an obstetric history of preeclampsia, according to ISSHP definition, who score ≥ 16 on the Perceived Stress Scale (PSS) ≥ 41 on the State-Trait Anxiety Inventory (STAI) or ≥ 10 on the Edinburgh Postnatal Depression Scale (EPDS) during online questionnaires as part of the anamnesis of PcCA will be prompted to join the study. Women with pre-existent diabetes mellitus, autoimmune disease, overt cardiovascular disease, or use of tabacco or medication that might affect the cardiovascular system are excluded from participation. Other exclusion criteria are plans to become pregnant within the time frame of the intervention (12 weeks) at time of baseline assessment.
Intervention: One group receives a 12-weeks standard online MBSR therapy, consisting of 8 weekly group meetings, one day silent retreat, and daily homework. A second group attends a 12-week aerobe training program which consists of HR-controlled training on a cycle trainer at 70-80% individual heart rate reserve (HRR) for 2 to 3 times per week. Finally, the time control (wait list) group will be asked to continue normal activities and lifestyle and won't undergo guided mindfulness therapy or exercise training during the 12 weeks study period.
Main study parameters: The primary endpoint is mental stress, evaluated with validated questionnaires PSS, STAI and EPDS. Secondary endpoints are the results of pre- and post-intervention pre-conceptional standard cardiovascular assessments. These cardiovascular assessments are in Maastricht UMC+ tertiary hospital care as usual after referral for preconceptional evaluation in women with a history of preeclampsia. This assessment includes: biometrics, 30-minutes blood pressure and heart rate measurement, venous blood samples for metabolic syndrome screening, echocardiography and plasma volume assessment. For this specific study the investigators will additionally assess cortisol concentration in hair and evaluate sympathetic activity during a head-up tilt test using non-invasive heart rate variability analysis. During the exercise training, heartbeat monitoring will be measured using smartwatches. Feasibility of the interventions will be evaluate with additional participant survey at follow-up measurement.
- Being tested
- Aerobic exercise training, Mindfulness Based Stress Reduction training
- Keywords
- Mindfulness Based Stress Reduction, Hair cortisol, Preeclampsia, Stress, Aerobic sports training
- Medical subject headings
- Pre-Eclampsia, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingBehavioural
See above in arm group descriptions.
Mindfulness Based Stress Reduction trainingBehavioural
See above in arm group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Sports | Experimental | Exercise training consists of 12-weeks of heartrate-controlled training on a cycle trainer at 70-80% individual heartrate reserve. The training will take place at a fitness center of the participant's own choice, women will receive a sport fee after inclusion. heartrate will be monitored continuously and recorded by a smartwatch. Training is personalized and consists of 60 minutes of cycling for 2 times (week: 1-6) to 3 times (week: 7-12) per week for one hour. Training includes intensity of 40 minutes on 70-80%. heartrate reserve (HRR) was calculated in the following manner: HHR=HRmax-HRrest, in which HRmax is assumed 220 bpm minus age. Receives: Behavioral: Aerobic exercise training |
| Sofa | Experimental | Participants will participate in an mindfullness based stress reduction (MBSR) training. The training consists of 8 weekly sessions lasting 2,5 hours per session. A silent day of approximately 6 hours is also included, as well as daily home practice assignments of about 45 minutes. During the training participants will learn to focus their attention in the present moment in an accepting and non-judgemental way, rather than ruminating about past and future experiences. The training will be offered online and is led by qualified teachers from Radboud university medical centre. Receives: Behavioral: Mindfulness Based Stress Reduction training |
| Waitlist | No intervention | The participants are asked during the intervention not to follow any diet. Women in the control group will be asked to continue normal physical activities and not to undertake Mindfulness therapy during the study period for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress
according to the measures on Perceived Stress Scale,minimum 0, maximum 40. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress
Measured: Pre-post intervention and 3 months follow up.
Anxiety symptoms
according to the measures on State-Trait Anxiety Inventory, Scores range from 20 to 80, with higher scores correlating with greater anxiety. Score above 40 represents significant anxiety symptoms
Measured: Pre-post intervention and 3 months follow up.
Depression symptoms
according to the measures on postnatal Depression Scale. Scores range from 0 to 30, with higher scores correlating with more depression symptoms. Score above 10 represents significant depression.
Measured: Pre-post intervention and 3 months follow up.
Secondary outcomes (15)
Weight
weight in kilograms
Measured: Pre-post intervention of 3 months.
Height
height in meters
Measured: Pre-post intervention of 3 months.
body surface area
body surface area (BSA) was calculated using the Dubois \& Dubois formula
Measured: Pre-post intervention of 3 months.
30-minutes blood pressure and heart rate measures
systolic and diastolic pressure in mmHg, heart reat in beat/min
Measured: Pre-post intervention of 3 months.
Sympathetic activity
Sympathetic activity was measured using the head-up tilt test (HUT) using a finometer. During this test orthostatic stress was tested to assess the changes in sympathetic activity.
Measured: Pre-post intervention of 3 months.
glucose
in mmol/L, venous blood samples for metabolic parameters were drawn in fasting state
Measured: Pre-post intervention of 3 months.
insulin
in mU/l, venous blood samples for metabolic parameters were drawn in fasting state
Measured: Pre-post intervention of 3 months.
total cholesterol
Venous blood samples for metabolic parameters were drawn in fasting state
Measured: Pre-post intervention of 3 months.
lowdensity lipoprotein cholesterol
Venous blood samples for metabolic parameters were drawn in fasting state
Measured: Pre-post intervention of 3 months.
high-density lipoprotein cholesterol
Venous blood samples for metabolic parameters were drawn in fasting state
Measured: Pre-post intervention of 3 months.
triglycerides
in mmol/L, venous blood samples for metabolic parameters were drawn in fasting state
Measured: Pre-post intervention of 3 months.
renal function
Venous blood sample for serum creatinine levels (in μmol/L).
Measured: Pre-post intervention of 3 months.
Urine sample
protein per liter
Measured: Pre-post intervention of 3 months.
Plasma volume
in ml, was measured by using the 125I-Human Serum Albumin indicator dilution technique (125I-has). It was calculated by dividing the total injected 125I-has by the virtual volume-specific radioactivity at time zero (31). Eventually plasma volume was calculated by dividing total plasma volume by BSA, resulting in ml/m2 (24).
Measured: Pre-post intervention of 3 months.
Hair cortisol concentration
cortisol in hair.
Measured: Pre-post intervention of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Apr 2022
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group receives a 12-weeks standard online MBSR therapy, consisting of 8 weekly group meetings, one day silent retreat, and daily homework. A second group attends a 12-week aerobe training program which consists of HR-controlled training on a cycle trainer at 70-80% individual heart rate reserve (HRR) for 2 to 3 times per week. Finally, the time control (wait list) group will be asked to continue normal activities and lifestyle and won't undergo guided mindfulness therapy or exercise training during the 12 weeks study period.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402604
- Sponsor's protocol ID
- NL78063.091.21
- Acronym
- SOS
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data available on request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Reduction in Formerly Preeclamptic Women; Sofa or Sports
- ClinicalTrials.gov ID
- NCT06402604
- Acronym / sponsor ID
- SOS / NL78063.091.21
- Keywords
- Mindfulness Based Stress Reduction, Hair cortisol, Preeclampsia, Stress, Aerobic sports training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 7 May 2024 (actual)
- 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.
The goal of this clinical trial is to evaluate stress and cardiovascular risk factors in women with preeclampsia in the medical history. The main questions it aims to answer are:
- to improve our understanding of the underlying psychological and physical stress factors in relation to the circulatory risk profile in women with a history of preeclampsia
- to examine the effects of mindfullness based stress reduction (MBSR) or aerobic exercise training on hair cortisol and symptoms of mental stress.
Participants will undergo pre- and post-intervention pre-conceptional standard cardiovascular assessments, head tilt test and give a hair sample. As intervention they will sport or do mindfulness for 3 months.They will be compared with a control group.
Detailed description
Rationale: Approximately one out of three women with pre-term preeclampsia develops a post-traumatic stress disorder or depression after pregnancy. This could be related to the psychological impact of preeclampsia and premature birth resulting in increased perceived stress. It is also possible that preeclampsia and stress levels share a common aetiology, as both appear to correlate with increased cortisol levels and higher sympathetic drive. Approximately 50% of women with a history of preeclampsia have low plasma volume levels, indicating reduced circulatory reserve. Women with a hemodynamic profile characterized by a limited circulatory reserve have increased resting sympathetic tone, and are prone to develop preeclampsia in a subsequent pregnancy. These women also report more complaints of perceived stress. This raises not only the question whether increased perceived stress in women with a history of preeclampsia originates within the brain itself (primary psychological) or whether it is a psychological reflection of underlying reduced circulatory reserves (secondary psychological), but also the question about which intervention is most effective to reduce this perceived stress level. Should the investigators focus more on the emotional coping mechanisms and psychological aspects or should the investigators aim at improving the underlying hemodynamic profile and circulatory reserves to reduce overall sympathetic drive? The investigators hypothesize that 1) both interventions in women with preeclampsia and increased mental stress complaints will result in improved circulatory reserve, lower cortisol levels, lower sympathetic resting tone, and better continuous physiological measures (as measured with a smartwatch during the trial). 2) The aerobic exercise training will additionally improve the women's cardiovascular risk profile.
Objective: To investigate the effects of online mindfulness-based stress reduction (MBSR) therapy and aerobe exercise training on mental stress, physiological stress (hair cortisol) and cardiovascular risk profile in women with a history of preeclampsia and current increased symptoms of mental stress.
Study design: Multicenter randomized trial of two interventions (online mindfulness therapy and aerobic exercise training) and a time control group who undergo neither of the two interventions (wait list group). Possible eligible women will be recruited in two tertiary hospitals (Radboudumc Nijmegen and Maastricht Medical Centre) after referral to these centres for preconceptional cardiovascular assessment after severe preeclampsia in a previous pregnancy. Participants with symptoms of mental stress will be randomly assigned to either one of the two intervention groups or the wait list (3 options) after the Preconceptional Cardiovascular Assessment (PcCA) and Stress Assessment (SA). After 12 weeks of intervention, or in the case of the wait list group, 12 weeks without intervention, another PcCA and SA will take place. Results after 12 weeks will be compared with baseline results. Additionally, in all groups online questionnaires will be filled in 6 months after baseline assessments. Women who were allocated to the wait list group are offered either mindfulness therapy or aerobic exercise training after completing the second PcCA and SA after 12 weeks.
Study population: Primiparous women with an obstetric history of preeclampsia, according to ISSHP definition, who score ≥ 16 on the Perceived Stress Scale (PSS) ≥ 41 on the State-Trait Anxiety Inventory (STAI) or ≥ 10 on the Edinburgh Postnatal Depression Scale (EPDS) during online questionnaires as part of the anamnesis of PcCA will be prompted to join the study. Women with pre-existent diabetes mellitus, autoimmune disease, overt cardiovascular disease, or use of tabacco or medication that might affect the cardiovascular system are excluded from participation. Other exclusion criteria are plans to become pregnant within the time frame of the intervention (12 weeks) at time of baseline assessment.
Intervention: One group receives a 12-weeks standard online MBSR therapy, consisting of 8 weekly group meetings, one day silent retreat, and daily homework. A second group attends a 12-week aerobe training program which consists of HR-controlled training on a cycle trainer at 70-80% individual heart rate reserve (HRR) for 2 to 3 times per week. Finally, the time control (wait list) group will be asked to continue normal activities and lifestyle and won't undergo guided mindfulness therapy or exercise training during the 12 weeks study period.
Main study parameters: The primary endpoint is mental stress, evaluated with validated questionnaires PSS, STAI and EPDS. Secondary endpoints are the results of pre- and post-intervention pre-conceptional standard cardiovascular assessments. These cardiovascular assessments are in Maastricht UMC+ tertiary hospital care as usual after referral for preconceptional evaluation in women with a history of preeclampsia. This assessment includes: biometrics, 30-minutes blood pressure and heart rate measurement, venous blood samples for metabolic syndrome screening, echocardiography and plasma volume assessment. For this specific study the investigators will additionally assess cortisol concentration in hair and evaluate sympathetic activity during a head-up tilt test using non-invasive heart rate variability analysis. During the exercise training, heartbeat monitoring will be measured using smartwatches. Feasibility of the interventions will be evaluate with additional participant survey at follow-up measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- One group receives a 12-weeks standard online MBSR therapy, consisting of 8 weekly group meetings, one day silent retreat, and daily homework. A second group attends a 12-week aerobe training program which consists of HR-controlled training on a cycle trainer at 70-80% individual heart rate reserve (HRR) for 2 to 3 times per week. Finally, the time control (wait list) group will be asked to continue normal activities and lifestyle and won't undergo guided mindfulness therapy or exercise training during the 12 weeks study period.
| Arm | Type | Receives |
|---|---|---|
| Sports | Experimental | Behavioral: Aerobic exercise trainingExercise training consists of 12-weeks of heartrate-controlled training on a cycle trainer at 70-80% individual heartrate reserve. The training will take place at a fitness center of the participant's own choice, women will receive a sport fee after inclusion. heartrate will be monitored continuously and recorded by a smartwatch. Training is personalized and consists of 60 minutes of cycling for 2 times (week: 1-6) to 3 times (week: 7-12) per week for one hour. Training includes intensity of 40 minutes on 70-80%. heartrate reserve (HRR) was calculated in the following manner: HHR=HRmax-HRrest, in which HRmax is assumed 220 bpm minus age. |
| Sofa | Experimental | Behavioral: Mindfulness Based Stress Reduction trainingParticipants will participate in an mindfullness based stress reduction (MBSR) training. The training consists of 8 weekly sessions lasting 2,5 hours per session. A silent day of approximately 6 hours is also included, as well as daily home practice assignments of about 45 minutes. During the training participants will learn to focus their attention in the present moment in an accepting and non-judgemental way, rather than ruminating about past and future experiences. The training will be offered online and is led by qualified teachers from Radboud university medical centre. |
| Waitlist | No intervention | –The participants are asked during the intervention not to follow any diet. Women in the control group will be asked to continue normal physical activities and not to undertake Mindfulness therapy during the study period for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent given
- Age > or = 18 years
- Good understanding of Dutch language
- Preeclampsia in prior pregnancy, defined as the combination of gestational hypertension (≥140/90 mmHg, measured twice, six hours or more apart), and proteinuria (consistently ≥300mg/24 hours) after 20 weeks of pregnancy in previously normotensive women, according to International Society for the Study of Hypertension in Pregnancy (Brown, 2018).
- Normotensive at the time of baseline measurements
Key exclusion criteria (6 listed)
- Pre-existent diabetes mellitus, autoimmune disease, HIV positivity or overt cardio-vascular disease.
- Use of medication or supplements that might affect the cardiovascular system
- (Physical) inabilities to complete 12 weeks of moderate exercise training
- Currently involved in psychological therapy or mindfullness training.
- Pregnancy
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 trainingSee above in arm group descriptions. | Behavioural | Sports |
| Mindfulness Based Stress Reduction trainingSee above in arm group descriptions. | Behavioural | Sofa |
Primary outcome
Perceived stress
Time frame: Pre-post intervention and 3 months follow up.
according to the measures on Perceived Stress Scale,minimum 0, maximum 40. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress
Anxiety symptoms
Time frame: Pre-post intervention and 3 months follow up.
according to the measures on State-Trait Anxiety Inventory, Scores range from 20 to 80, with higher scores correlating with greater anxiety. Score above 40 represents significant anxiety symptoms
Depression symptoms
Time frame: Pre-post intervention and 3 months follow up.
according to the measures on postnatal Depression Scale. Scores range from 0 to 30, with higher scores correlating with more depression symptoms. Score above 10 represents significant depression.
15 secondary outcomes
Weight
Time frame: Pre-post intervention of 3 months.
Height
Time frame: Pre-post intervention of 3 months.
body surface area
Time frame: Pre-post intervention of 3 months.
30-minutes blood pressure and heart rate measures
Time frame: Pre-post intervention of 3 months.
Sympathetic activity
Time frame: Pre-post intervention of 3 months.
glucose
Time frame: Pre-post intervention of 3 months.
insulin
Time frame: Pre-post intervention of 3 months.
total cholesterol
Time frame: Pre-post intervention of 3 months.
lowdensity lipoprotein cholesterol
Time frame: Pre-post intervention of 3 months.
high-density lipoprotein cholesterol
Time frame: Pre-post intervention of 3 months.
triglycerides
Time frame: Pre-post intervention of 3 months.
renal function
Time frame: Pre-post intervention of 3 months.
Urine sample
Time frame: Pre-post intervention of 3 months.
Plasma volume
Time frame: Pre-post intervention of 3 months.
Hair cortisol concentration
Time frame: Pre-post intervention of 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 17 Jan 2025.
- Individual participant dataSharing planned: Undecided. Individual participant data available on request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 and Mindfulness Based Stress Reduction training in people with Preeclampsia and Stress, Psychological, run by Radboud University Medical Center at 2 sites 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 6 inclusion and 6 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 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Perceived stress (time frame: Pre-post intervention and 3 months follow up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2025.