Physical Activity and Cardiovascular Profile of Pre-conceptional Women At Risk for GHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorHasselt University
About this trial
To compare the cardiovascular profile of pre-conceptional women at risk for developing Gestational Hypertensive Disorders in subsequent pregnancy before and after physical activity.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
supervised infrared exercise group
Other interventionParticipants 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
Other interventionParticipants 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
Other interventionParticipants 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.
Treatment groups
140 Participants
are divided into 3 treatment groupsGroup A: Control groupOther 1 intervention
Group B: Intervention: supervised non-infrared exercise groupActive comparator 1 intervention
Group C: Intervention: supervised infrared exercise groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in cardiac output level from Baseline at week 12 visit
Cardiac Output assessed via the NICCOMO
Time frame
Baseline and week 12Secondary outcomes
1
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
Time frame
Baseline and week 122
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)
Time frame
Baseline and week 123
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)
Time frame
Baseline and week 124
Change in body water volumes from Baseline at week 12 visit
total body water (TBW), extracellular water (ECW), intracellular water (ICW), ratio ECW/ICW
Time frame
Baseline and week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov