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

Last updated: March 21, 2025
Sponsor: Hasselt University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

High Blood Pressure (Hypertension - Pediatric)

Treatment

supervised infrared exercise group

Control group

supervised non-infrared exercise group

Clinical Study ID

NCT05888467
SPORTY-01
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

  • Women at risk for the development of GHD in subsequent pregnancy based on thepresence 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 subsequentpregnancy

  • 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

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 asoncological diseases coronary heart disease, aortic disease, peripheral arterialdisease

  • Participating in another clinical study that may alter the results of this study

Study Design

Total Participants: 140
Treatment Group(s): 3
Primary Treatment: supervised infrared exercise group
Phase:
Study Start date:
May 15, 2023
Estimated Completion Date:
December 31, 2025

Study Description

The SPORTY trial hypothesizes that exercise improves the cardiovascular (CV) profile of pre-conceptional women at risk for developing gestational hypertensive disorders (GHD) in subsequent pregnancy in a profile-specific way.

Research objectives:

The primary objective is to compare the complete CV profile before and after an exercise period of 6 and 12 weeks.

Secondary objectives are:

  • To correlate the exercise-induced changes in CV profile to the type, frequency and intensity of exercise.

  • To evaluate the added value of supervised and personalized training in inducing changes in the CV profile compared to non-supervised training.

  • To evaluate the added value of infrared light therapy during supervised training in inducing changes in the CV profile compared to non-infrared supervised training.

  • To assess how long the adaptations in the CV profile induced by supervised training last in case the supervision is halted.

Methodology:

All study participants who provided written informed consent and are eligible to participate in the study are 2:1:1 randomly assigned into a non-supervised exercise group (control), a supervised non-infrared exercise group (intervention), or a supervised infrared exercise group (intervention), stratified by baseline cardiac output (CO).

All study participants will undergo a CV profiling assessment at baseline, at week 6 visit, at week 12 visit, and at week 18 visit. The CV profile assessment is a standardized validated protocol consisting of a simple, non-invasive method using the combination of (1) electrocardiogram (ECG) with Doppler ultrasonography providing information about arteries and veins, (2) Bio-Impedance Spectrum Analysis (BI) using Maltron giving information about the fluid balance, and (3) Impedance Cardiography (ICG) using the NICCOMO registering heart parameters in supine and standing position. The CV profiling will be performed at UHasselt (building A) or at Ziekenhuis Oost-Limburg (Campus Sint-Jan) in the framework of the Limburg Clinical Research Center.

All participants are asked to complete the International Physical Activity Questionnaire (IPAQ) online in Castor EDC at home to report their baseline physical activity status. Demographics, clinical characteristics and medical history are obtained and reported in the eCRF.

For ethical reasons, all study groups will be advised to exercise for a period of 12 weeks, but only the two supervised exercise groups will receive a personalized and guided exercise plan. In addition, all participants will receive an activity diary and are asked to fill in their weekly exercise throughout the entire study period.

Connect with a study center

  • Hasselt University

    Diepenbeek, Limburg 3590
    Belgium

    Active - Recruiting

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