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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Aerobic exercise training and Mindfulness Based Stress Reduction training
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

Other trials in Netherlands

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 groups in NCT06402604
Study groupRoleWhat they receive
SportsExperimentalExercise 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
SofaExperimentalParticipants 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
WaitlistNo interventionThe 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.

  1. 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.

  2. 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.

  3. 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)
  1. Weight

    weight in kilograms

    Measured: Pre-post intervention of 3 months.

  2. Height

    height in meters

    Measured: Pre-post intervention of 3 months.

  3. body surface area

    body surface area (BSA) was calculated using the Dubois \& Dubois formula

    Measured: Pre-post intervention of 3 months.

  4. 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.

  5. 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.

  6. glucose

    in mmol/L, venous blood samples for metabolic parameters were drawn in fasting state

    Measured: Pre-post intervention of 3 months.

  7. insulin

    in mU/l, venous blood samples for metabolic parameters were drawn in fasting state

    Measured: Pre-post intervention of 3 months.

  8. total cholesterol

    Venous blood samples for metabolic parameters were drawn in fasting state

    Measured: Pre-post intervention of 3 months.

  9. lowdensity lipoprotein cholesterol

    Venous blood samples for metabolic parameters were drawn in fasting state

    Measured: Pre-post intervention of 3 months.

  10. high-density lipoprotein cholesterol

    Venous blood samples for metabolic parameters were drawn in fasting state

    Measured: Pre-post intervention of 3 months.

  11. triglycerides

    in mmol/L, venous blood samples for metabolic parameters were drawn in fasting state

    Measured: Pre-post intervention of 3 months.

  12. renal function

    Venous blood sample for serum creatinine levels (in μmol/L).

    Measured: Pre-post intervention of 3 months.

  13. Urine sample

    protein per liter

    Measured: Pre-post intervention of 3 months.

  14. 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.

  15. 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.

  1. First posted7 May 2024
  2. Study start1 Apr 2022
  3. Primary completion23 Sep 2024
  4. Study completion23 Sep 2024

Resources

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)
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.

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.

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