Clinical trial NCT05888467: Physical Activity and Cardiovascular Profile of Pre-conceptional Women At Risk for GHD
Official title: The Impact of Physical Activity on the Cardiovascular Profile of Pre-conceptional Women At Risk for Developing Gestational Hypertensive Disorders in Subsequent Pregnancy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Hypertension
Cardiovascular Pregnancy Complication
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, monocentric, interventional, randomized-controlled trial
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Change in cardiac output level from Baseline at week 12 visit
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change in arterial parameters from Baseline at week 12 visit
timeFrame: Baseline and week 12
measure: Change in venous parameters from Baseline at week 12 visit
timeFrame: Baseline and week 12
measure: Change in cardiac parameters from Baseline at week 12 visit
timeFrame: Baseline and week 12
measure: Change in body water volumes from Baseline at week 12 visit
timeFrame: Baseline and week 12
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: UHasselt
name: Dorien Lanssens
role: PRINCIPAL_INVESTIGATOR
References: