Gestational HypertensionSPORTYNCT05888467
Physical Activity and Cardiovascular Profile of Pre-conceptional Women At Risk for GHD
A study testing supervised infrared exercise group and supervised non-infrared exercise group in people with Gestational Hypertension and Cardiovascular Pregnancy Complication, run by Hasselt University at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Hypertension, Cardiovascular Pregnancy Complication
- What is being tested?
- supervised infrared exercise group and supervised non-infrared exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- 15 May 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Diepenbeek, Limburg, 3590
Marleen Missotten, 011268502 ext. +32, marleen.missotten@uhasselt.be
About this study
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.
To compare the cardiovascular profile of pre-conceptional women at risk for developing Gestational Hypertensive Disorders in subsequent pregnancy before and after physical activity.
Read the 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.
- Being tested
- supervised infrared exercise group, supervised non-infrared exercise group, Control group
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pregnancy Complications, Cardiovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised infrared exercise groupOther
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 groupOther
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 groupOther
Also called non-supervised exercise 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | non-supervised exercise group Receives: Other: Control group |
| Intervention: supervised non-infrared exercise group | Active comparator | supervised non-infrared exercise group Receives: Other: supervised infrared exercise group |
| Intervention: supervised infrared exercise group | Active comparator | supervised infrared exercise group Receives: Other: supervised non-infrared exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac output level from Baseline at week 12 visit
Cardiac Output assessed via the NICCOMO
Measured: Baseline and week 12
Secondary outcomes (4)
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
Measured: 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)
Measured: 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)
Measured: 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
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start15 May 2023
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, monocentric, interventional, randomized-controlled trial
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Dorien Lanssens, Hasselt University
- Investigators
- Dorien Lanssens, Principal investigator, UHasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888467
- Sponsor's protocol ID
- SPORTY-01
- Acronym
- SPORTY
- Status last verified
- Mar 2025
- First submitted
- 16 May 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05888467
- Acronym / sponsor ID
- SPORTY / SPORTY-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective, monocentric, interventional, randomized-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Control groupnon-supervised exercise group |
| Intervention: supervised non-infrared exercise group | Active comparator | Other: supervised infrared exercise groupsupervised non-infrared exercise group |
| Intervention: supervised infrared exercise group | Active comparator | Other: supervised non-infrared exercise groupsupervised infrared exercise group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women at risk for the development of GHD in subsequent pregnancy based on the presence of at least one of the following risk factors:
- Non-pregnant (as confirmed by a negative pregnancy urine dipstick test)
- Age ≥ 18 years
- Being able to understand the Dutch language
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supervised infrared exercise groupParticipants 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. | Other | Intervention: supervised non-infrared exercise group |
| supervised non-infrared exercise groupParticipants 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. | Other | Intervention: supervised infrared exercise group |
| Control groupAlso: non-supervised exercise groupParticipants 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 | Control group |
Primary outcome
Change in cardiac output level from Baseline at week 12 visit
Time frame: Baseline and week 12
Cardiac Output assessed via the NICCOMO
4 secondary outcomes
Change in arterial parameters from Baseline at week 12 visit
Time frame: Baseline and week 12
Change in venous parameters from Baseline at week 12 visit
Time frame: Baseline and week 12
Change in cardiac parameters from Baseline at week 12 visit
Time frame: Baseline and week 12
Change in body water volumes from Baseline at week 12 visit
Time frame: Baseline and week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorien Lanssens principal investigator
UHasselt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supervised infrared exercise group and supervised non-infrared exercise group in people with Gestational Hypertension and Cardiovascular Pregnancy Complication, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline Dreesen (089212030 ext. +32, pauline.dreesen@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac output level from Baseline at week 12 visit (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.