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NCT Number: NCT06565182

The Acute Effect of Physical Exercise in Pregnancy

The goal of this crossover clinical trial is to investigate the acute physiological effect of exercise on the uterine and fetal blood flow in pregnancy. The main questions it aims to answer are:

* What is the acute physiological effect of exercise on the uterine and fetal blood flow in pregnancy? * What is the acute physiological effect of continuous aerobic exercise versus resistance exercise on the uterine and fetal blood flow in pregnancy? * What is the effect of physical activity levels on the uterine and fetal blood flow in pregnancy?

Researchers will compare the continuous aerobic exercise to the resistance exercise with a 3-6-week interval to examine the acute physiological effect on the uterine and fetal blood flow.

Participants will:

* Fill in a physical activity level questionnaire at baseline. * Complete either continuous aerobic exercise or resistance exercise and take blood flow measurements. * Complete the remaining type of exercise after a 3-6-week interval and take blood flow measurements.

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Key information

Conditions

Pregnancy Related Behavior Motor Activity

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant, over the age of 18 years, singleton pregnancy, both primigravidas and multigravidas, uncomplicated pregnancy and absence of contra-indications for exercise as per Canadian guidelines (Mottola et al. 2018).

Exclusion criteria

  • smoking, substance abuse, chronic diseases, fetal growth restriction, fetal abnormalities, hypertension, history of premature delivery, vaginal hemorrhage, placenta previa, contractions before/during intervention, diabetes mellitus, preeclampsia and previous pregnancy complications.

Treatment and study plan

Exercise

Other

The intervention consists of two different types of moderate intensity exercise: Continuous aerobic and resistance exercise.

Primary outcomes

  1. Blood flow using doppler ultrasound measurements

    Time frame: The measurements were taken before and after each exercise bout. Participants rested for at least 15 minutes before their baseline measurement was evaluated. Reassessment was done within 15 minutes after the intervention.

    Measurements of the pulsatility index of the left and right uterine artery, umbilical artery and middle cerebral artery were taken using Doppler ultrasound. The pulsatility indexes were determined by taking the average of three waveforms from the Doppler velocity measurements.

Secondary outcomes

  1. Physical activity levels

    Time frame: Physical activity levels were assessed at baseline.

    Physical fitness levels were assessed using the Dutch version of the IPAQ-SF questionnaire. Categorical scores are defined as low, moderate and high physical activity levels. The category labeled 'high' is classified when vigorous-intensity activity on at least 3 days achieves a minimum of at least 1500 MET-minutes/week or 7 or more days of any combination of walking, moderate-intensity or vigorous-intensity activities achieve a minimum of at least 3000 MET-minutes/week on total physical activity. 'Moderate' is classified if vigorous-intensity activity is performed for at least 20 minutes per day on 3 or more days; or moderate-intensity activity and/or walking is performed at least 30 minutes per day for 5 or more days; or 5 or more days of any combination of walking, moderate intensity or vigorous-intensity activities achieve a total physical activity of at least 600 MET minutes/week. All who do not meet the criteria for 'moderate' or 'high' are assigned to the category 'low'.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

The Acute Effect of Physical Exercise in Pregnancy on the Fetoplacental Unit: A Randomized Crossover Trial Comparing Aerobic Versus Resistance Exercise

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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