Pregnancy RelatedNCT06565182
The Acute Effect of Physical Exercise in Pregnancy
A study testing Exercise in people with Pregnancy Related, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2021to 26 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effect of Physical Exercise in Pregnancy on the Fetoplacental Unit: A Randomized Crossover Trial Comparing Aerobic Versus Resistance Exercise
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?
Read more
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.
- Conditions
- Pregnancy Related
- Being tested
- Exercise
- Keywords
- blood flow, pregnancy, aerobic exercise, resistance exercise, doppler ultrasound, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The intervention consists of two different types of moderate intensity exercise: Continuous aerobic and resistance exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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'.
Measured: Physical activity levels were assessed at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start15 Nov 2021
- Primary completion6 May 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565182
- Sponsor's protocol ID
- EDGE002233
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Physical Exercise in Pregnancy on the Fetoplacental Unit: A Randomized Crossover Trial Comparing Aerobic Versus Resistance Exercise
- ClinicalTrials.gov ID
- NCT06565182
- Acronym / sponsor ID
- EDGE002233
- Conditions
- Pregnancy Related
- Keywords
- blood flow, pregnancy, aerobic exercise, resistance exercise, doppler ultrasound, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous aerobic exercise | Experimental | Other: ExerciseThe 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. |
| Resistance exercise | Experimental | Other: ExerciseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe intervention consists of two different types of moderate intensity exercise: Continuous aerobic and resistance exercise. | Other | Continuous aerobic exercise, Resistance exercise |
Primary outcome
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.
1 secondary outcome
Physical activity levels
Time frame: Physical activity levels were assessed at baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Pregnancy Related, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.