Physical Activity and Cardiovascular Profile of Pre-conceptional Women At Risk for GHD
NCT ID: NCT05888467
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2023-05-15
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control group
non-supervised exercise group
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.
Intervention: supervised non-infrared exercise group
supervised non-infrared exercise group
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.
Intervention: supervised infrared exercise group
supervised infrared exercise group
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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Hasselt University
OTHER
Responsible Party
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Dr. Dorien Lanssens
Principal Investigator
Principal Investigators
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Dorien Lanssens
Role: PRINCIPAL_INVESTIGATOR
UHasselt
Locations
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Hasselt University
Diepenbeek, Limburg, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SPORTY-01
Identifier Type: -
Identifier Source: org_study_id
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