Exercise and Heart Health in Women at Risk for Pregnancy Complications
The Impact of Physical Activity on the Cardiovascular Profile of Pre-conceptional Women At Risk for Developing Gestational Hypertensive Disorders in Subsequent Pregnancy.
This study is testing whether different types of exercise can improve heart health in women at risk for pregnancy complications before they conceive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Hasselt University Academic / other |
| Locations | 1 site (Diepenbeek, Limburg) |
| Trial ID | NCT05888467 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the cardiovascular profile of pre-conceptional women who are at risk for developing gestational hypertensive disorders (GHD) before and after a structured exercise program. Participants will be randomly assigned to one of three groups: a non-supervised exercise group, a supervised non-infrared exercise group, or a supervised infrared exercise group. The study will assess changes in cardiovascular health over a 12-week period, with evaluations at baseline, 6 weeks, 12 weeks, and 18 weeks. The trial also seeks to understand the impact of exercise type and supervision on cardiovascular improvements.
Who should consider this trial
Good fit: Ideal candidates are non-pregnant women aged 18 and older with risk factors for developing gestational hypertensive disorders.
Not a fit: Patients who are currently pregnant or have serious underlying cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health in women at risk for GHD, potentially reducing complications in future pregnancies.
How similar studies have performed: While there is ongoing research in exercise and cardiovascular health, this specific approach focusing on pre-conceptional women at risk for GHD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women at risk for the development of GHD in subsequent pregnancy based on the presence of at least one of the following risk factors: * high body mass index (BMI\>30 kg/m²) * a family history of PE (mother, sister) * in the need of assisted reproduction techniques in a previous or subsequent pregnancy * maternal comorbidities: prior PE, diabetes mellitus, chronic hypertension, chronic kidney disease or antiphospholipid syndrome * Non-pregnant (as confirmed by a negative pregnancy urine dipstick test) * Age ≥ 18 years * Being able to understand the Dutch language Exclusion Criteria: Participants eligible for this study must not meet any of the following criteria: * Pregnant at inclusion * Not being able to exercise according to physician's decision * Suffering from underlying diseases that can affect the CV profile such as oncological diseases coronary heart disease, aortic disease, peripheral arterial disease * Participating in another clinical study that may alter the results of this study
Where this trial is running
Diepenbeek, Limburg
- Hasselt University — Diepenbeek, Limburg, Belgium (Recruiting)
Study contacts
- Principal investigator: Dorien Lanssens — UHasselt
- Study coordinator: Pauline Dreesen
- Email: pauline.dreesen@uhasselt.be
- Phone: 089212030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.