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

The Impact of Physical Activity on the Cardiovascular Profile of Pre-conceptional Women At Risk for Developing Gestational Hypertensive Disorders in Subsequent Pregnancy.

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

Study Overview

• Status: Recruiting
• Conditions: Gestational Hypertension; Cardiovascular Pregnancy Complication
• Intervention / Treatment: Other: Control group; Other: supervised infrared exercise group; Other: supervised non-infrared exercise group

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pauline Dreesen; Phone Number: +32 089212030; Email: pauline.dreesen@uhasselt.be

Study Locations

• Belgium
  • Limburg
    • Diepenbeek, Limburg, Belgium, 3590
      • Recruiting
      • Hasselt University
      • Contact: Marleen Missotten; Phone Number: +32 011268502; Email: marleen.missotten@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; non-supervised exercise group	Other: 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.; Other Names: non-supervised exercise group
Active Comparator: Intervention: supervised non-infrared exercise group; supervised non-infrared exercise group	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.
Active Comparator: Intervention: supervised infrared exercise group; supervised infrared exercise group	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiac output level from Baseline at week 12 visit	Cardiac Output assessed via the NICCOMO	Baseline and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Principal Investigator: Dorien Lanssens, UHasselt

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Hypertension; Hypertension, Pregnancy-Induced; Pregnancy Complications; Pregnancy Complications, Cardiovascular
• Other Study ID Numbers: SPORTY-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No