Physical Activity and Cardiovascular Profile of Pre-conceptional Women At Risk for GHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: supervised infrared exercise group, supervised non-infrared exercise group, Control group.
- Who it may be relevant to
- Registry conditions: Gestational Hypertension, Cardiovascular Pregnancy Complication. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- 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. - 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. - 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.
Primary outcome measures
- Change in cardiac output level from Baseline at week 12 visit [Time frame: Baseline and week 12]
Secondary outcome measures (4)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Belgium · 1 center
- Hasselt University — Diepenbeek
Identifiers
NCT: NCT05888467 · SPORTY-01