NCT05888467RecruitingNot Applicable
The Impact of Physical Activity on the Cardiovascular Profile of Pre-conceptional Women At Risk for Developing Gestational Hypertensive Disorders in Subsequent Pregnancy.
Hasselt University2 sites in 1 country140 target enrollmentStarted: May 15, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Change in cardiac output level from Baseline at week 12 visit
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in cardiac output level from Baseline at week 12 visit
Time Frame: Baseline and week 12
Cardiac Output assessed via the NICCOMO
Secondary Outcomes
- Change in arterial parameters from Baseline at week 12 visit(Baseline and week 12)
- Change in venous parameters from Baseline at week 12 visit(Baseline and week 12)
- Change in cardiac parameters from Baseline at week 12 visit(Baseline and week 12)
- Change in body water volumes from Baseline at week 12 visit(Baseline and week 12)
Investigators
Dr. Dorien Lanssens
Principal Investigator
Hasselt University
Study Sites (2)
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