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Physical Activity and Cardiovascular Profile of Pre-conceptional Women at Risk for GHD (SPORTY)

Primary Purpose

Gestational Hypertension, Cardiovascular Pregnancy Complication

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
supervised infrared exercise group
supervised non-infrared exercise group
Control group
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gestational Hypertension

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hasselt UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Control group

Intervention: supervised non-infrared exercise group

Intervention: supervised infrared exercise group

Arm Description

non-supervised exercise group

supervised non-infrared exercise group

supervised infrared exercise group

Outcomes

Primary Outcome Measures

Change in cardiac output level from Baseline at week 12 visit
Cardiac Output assessed via the NICCOMO

Secondary Outcome Measures

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
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)
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)
Change in body water volumes from Baseline at week 12 visit
total body water (TBW), extracellular water (ECW), intracellular water (ICW), ratio ECW/ICW

Full Information

First Posted
May 16, 2023
Last Updated
May 25, 2023
Sponsor
Hasselt University
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1. Study Identification

Unique Protocol Identification Number
NCT05888467
Brief Title
Physical Activity and Cardiovascular Profile of Pre-conceptional Women at Risk for GHD
Acronym
SPORTY
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Hypertension, Cardiovascular Pregnancy Complication

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, monocentric, interventional, randomized-controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
non-supervised exercise group
Arm Title
Intervention: supervised non-infrared exercise group
Arm Type
Active Comparator
Arm Description
supervised non-infrared exercise group
Arm Title
Intervention: supervised infrared exercise group
Arm Type
Active Comparator
Arm Description
supervised infrared exercise group
Intervention Type
Other
Intervention Name(s)
supervised infrared exercise group
Intervention Description
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 Type
Other
Intervention Name(s)
supervised non-infrared exercise group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
non-supervised exercise group
Intervention Description
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 Measure Information:
Title
Change in cardiac output level from Baseline at week 12 visit
Description
Cardiac Output assessed via the NICCOMO
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Change in arterial parameters from Baseline at week 12 visit
Description
arterial pulse transit time (APTT), pulsatility index (PI) and resistivity index (RI) of the left and right arcuate arteries
Time Frame
Baseline and week 12
Title
Change in venous parameters from Baseline at week 12 visit
Description
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 12
Title
Change in cardiac parameters from Baseline at week 12 visit
Description
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 12
Title
Change in body water volumes from Baseline at week 12 visit
Description
total body water (TBW), extracellular water (ECW), intracellular water (ICW), ratio ECW/ICW
Time Frame
Baseline and week 12

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Non-pregnant women at risk for the development of GHD in subsequent pregnancy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline Dreesen
Phone
089212030
Ext
+32
Email
pauline.dreesen@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorien Lanssens
Organizational Affiliation
UHasselt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasselt University
City
Diepenbeek
State/Province
Limburg
ZIP/Postal Code
3590
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marleen Missotten
Phone
011268502
Ext
+32
Email
marleen.missotten@uhasselt.be

12. IPD Sharing Statement

Learn more about this trial

Physical Activity and Cardiovascular Profile of Pre-conceptional Women at Risk for GHD

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