Stress Reduction in Formerly Preeclamptic Women; Sofa or Sports

NCT06402604 | Completed DMC

• 1 other identifier: NL78063.091.21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Preeclampsia; Stress, Psychological; Stress, Physiological; Sports Physical Therapy

Keywords

Mindfulness Based Stress Reduction; Hair cortisol; Preeclampsia; Stress; Aerobic sports training

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  Pre-post intervention and 3 months follow up.

Secondary Outcomes (15)

• Weight

  Pre-post intervention of 3 months.

• Height

  Pre-post intervention of 3 months.

• body surface area

  Pre-post intervention of 3 months.

• 30-minutes blood pressure and heart rate measures

  Pre-post intervention of 3 months.

• Sympathetic activity

  Pre-post intervention of 3 months.

Other Outcomes (13)

• Age

  Pre-intervention.

• highest education

  Pre-intervention.

• Smoking

  Pre-intervention.

Study Arms (3)

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.

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.

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.

Interventions

Aerobic exercise training BEHAVIORAL

See above in arm group descriptions.

Sports

Mindfulness Based Stress Reduction training BEHAVIORAL

See above in arm group descriptions.

Sofa

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women with obstetric history.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Maastricht University Medical Center: collaborator

Study Sites (2)

Joris J.A. van Esch

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Maastricht UMC+

Maastricht, Limburg, 6202AZ, Netherlands

Location

MeSH Terms

Conditions

Pre-Eclampsia; Stress, Psychological

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 7, 2024
• Study Start: April 1, 2022
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: January 17, 2025

Record last verified: 2023-05

Locations

NL (2)