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

Gestational Hypertension Clinical Trial

— SPORTY  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888467
• Other study ID #: SPORTY-01
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: November 2024

Study information

• Verified date: May 2023
• Source: Hasselt University
• Contact: Pauline Dreesen
• Phone: 089212030
• Email: pauline.dreesen[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: November 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Gestational Hypertension
• Hypertension, Pregnancy-Induced
• Pregnancy Complications

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Belgium	Hasselt University	Diepenbeek	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiac output level from Baseline at week 12 visit	Cardiac Output assessed via the NICCOMO	Baseline and week 12
Secondary	Change in arterial parameters from Baseline at week 12 visit	arterial pulse transit time (APTT), pulsatility index (PI) and resistivity index (RI) of the left and right arcuate arteries	Baseline and week 12
Secondary	Change in venous parameters from Baseline at week 12 visit	enous pulse transit time (VPTT) of the hepatic and left and right renal veins, hepatic vein impedance index (HVI), and left and right renal interlobar vein impedance indices (RIVI)	Baseline and week 12
Secondary	Change in cardiac parameters from Baseline at week 12 visit	stroke volume (SV), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), pre-ejection period (PEP), total peripheral resistance (TPR), left ventricular ejection time (LVET), velocity and acceleration indices (VI and ACI)	Baseline and week 12
Secondary	Change in body water volumes from Baseline at week 12 visit	total body water (TBW), extracellular water (ECW), intracellular water (ICW), ratio ECW/ICW	Baseline and week 12