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

NCT05888467 | Recruiting

• 1 other identifier: SPORTY-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Hypertension; Cardiovascular Pregnancy Complication

Outcome Measures

Primary Outcomes (1)

• Change in cardiac output level from Baseline at week 12 visit

  Cardiac Output assessed via the NICCOMO

  Baseline and week 12

Secondary Outcomes (4)

• 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

Study Arms (3)

Control group

OTHER

non-supervised exercise group

Other: Control group

Intervention: supervised non-infrared exercise group

ACTIVE COMPARATOR

supervised non-infrared exercise group

Other: supervised infrared exercise group

Intervention: supervised infrared exercise group

ACTIVE COMPARATOR

supervised infrared exercise group

Other: supervised non-infrared exercise group

Interventions

supervised infrared exercise group OTHER

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 non-infrared exercise group

supervised non-infrared exercise group OTHER

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: supervised infrared exercise group

Control group OTHER

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.

Also known as: non-supervised exercise group

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Non-pregnant women at risk for the development of GHD in subsequent pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Participants eligible for this study must not meet any of the following criteria:
• 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

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pregnancy Complications, Cardiovascular

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dorien Lanssens

  UHasselt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline Dreesen

CONTACT

089212030; pauline.dreesen@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, monocentric, interventional, randomized-controlled trial

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 5, 2023
• Study Start: May 15, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

BE (1)