Stress reduction in formerly preeclamptic women; sofa or sports?

Conditions: preeclampsia
10026908
10057166

Registration Number: NL-OMON50491

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 84

Inclusion Criteria

- Informed consent given
- Age * 18 years
- Good understanding of Dutch language
- Preeclampsia in prior pregnancy, defined as the combination of gestational
hypertension (>=140/90mmHg, measured twice, six hours or more apart), and
proteinuria (consistently >=300mg/24 hours) after 20 weeks of pregnancy in
previously normotensive women, according to ISSHP definition (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

Exclusion Criteria

- 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 MBSR training.
- Pregnancy
- Women who intend to become pregnant within 12 weeks after baseline assessment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is mental stress, measured by validated questionnaires about<br /><br>anxiety, perceived stress and symptoms of depression. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the results of pre- and post-intervention<br /><br>pre-conceptionally cardiovascular assessments, which with take place as care-<br /><br>as-usual. These measures include: body surface area, 30-minutes blood pressure<br /><br>and heart rate measures, venous blood samples for metabolic syndrome,<br /><br>echocardiography and plasma volume. Additionally, cortisol concentration in<br /><br>hair and head-up tilt test are analyzed. During intervention period, daily life<br /><br>stress and heartbeat monitoring with be measured through continious<br /><br>physiological recordings using smartwatches and will be analyzed to monitor<br /><br>compliance to intervention and examine the relationship between daily life<br /><br>functioning clinical efficacy of MBSR or aerobe cycling training. Results of<br /><br>validated questionnaires STAI, EPDS and Symptom-Checklist-90 (SCL-90) 12 weeks<br /><br>after intervention will be used as follow-up. </p><br>