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Clinical Trials in Belgium / NCT05888467
Recruiting Not applicable

Physical Activity and Cardiovascular Profile of Pre-conceptional Women At Risk for GHD

NCT05888467 · tracked via the Priya Life Science Belgium tracker
Sponsor
Hasselt University
Phase
Not applicable
Started
2023-05-15
Last updated
2025-03-26

Condition(s) studied

Gestational HypertensionCardiovascular Pregnancy Complication

Investigational drug(s) / intervention(s)

supervised infrared exercise groupsupervised non-infrared exercise groupControl group

supervised infrared exercise group: Participants of the intervention group will be asked to perform 1-3 exercise sessions per week at the Infraligne center of Genk, Hasselt or Maasmechelen for a total duration of 12 weeks. During the exercise session, the participant is assigned to an individual 'sport cabin' in which they are standardly exposed to infrared light.

supervised non-infrared exercise group: Participants of the intervention group will be asked to perform 1-3 exercise sessions per week at the Infraligne center of Genk, Hasselt or Maasmechelen for a total duration of 12 weeks. Participants assigned to the supervised non-infrared exercise group will exercise in the sport-cabin with the infrared light turned off.

Control group: Participants of the control group are advised to perform moderate intensity aerobic exercise at least 3 days per week for an average of 30-50 minutes per session and a total duration of 12 weeks.

Study summary

To compare the cardiovascular profile of pre-conceptional women at risk for developing Gestational Hypertensive Disorders in subsequent pregnancy before and after physical activity.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Change in cardiac output level from Baseline at week 12 visit — Baseline and week 12
    Cardiac Output assessed via the NICCOMO

Trial sites (1)

FacilityCityRegionStatus
Hasselt University Diepenbeek Limburg Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05888467 on ClinicalTrials.gov ↗ ← All trials in Belgium