Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT05888467
Brief 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.
Detailed 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.
Study:
NCT05888467
Study Brief:
Protocol Section:
NCT05888467