NCT06565182

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 19, 2024

Last Update Submit

August 20, 2024

Conditions

Keywords

blood flowpregnancyaerobic exerciseresistance exercisedoppler ultrasoundphysical activity

Outcome Measures

Primary Outcomes (1)

  • Blood flow using doppler ultrasound measurements

    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.

    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.

Secondary Outcomes (1)

  • Physical activity levels

    Physical activity levels were assessed at baseline.

Study Arms (2)

Continuous aerobic exercise

EXPERIMENTAL

The continuous aerobic intervention was performed on a bicycle in a seated position at a moderate exercise intensity. Heart rate and RPE was implemented to ensure moderate intensity level. The participants were allowed to warm up for 5 minutes before starting to cycle at the predetermined HR ranges for 25 minutes. The total duration of exercise was 30 minutes.

Other: Exercise

Resistance exercise

EXPERIMENTAL

The acute resistance intervention consisted of four exercises performed using Technogym equipment at a moderate intensity. Every exercise consisted of 3 sets of 20 repetitions, with 1 minute rest in between sets, equaling 30 minutes of exercise in total. The four exercises were performed using the following Technogym devices: vertical traction, chest press, low row, leg press. Prior to the start of each exercise, a short maximal resistance test provided by the Technogym equipment was executed to determine moderate intensity.

Other: Exercise

Interventions

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

Continuous aerobic exerciseResistance exercise

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 21, 2024

Study Start

November 15, 2021

Primary Completion

May 6, 2022

Study Completion

May 26, 2022

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations