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Physical Activity and Vascular Health During Pregnancy

Can Physical Activity During Pregnancy Improve Maternal and Offspring Vascular Health?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03079258
Enrollment
20
Registered
2017-03-14
Start date
2017-04-23
Completion date
2019-08-03
Last updated
2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant, Sedentary Lifestyle

Keywords

vascular structure, vascular function, cerebrovascular reactivity, physical activity, sedentary behaviour, offspring health, maternal health

Brief summary

The aim of this study is to determine the effect of aerobic exercise on maternal and offspring vascular health.

Detailed description

The study will comprise of a randomised pilot trial to assess the effect of a moderate intensity exercise intervention on maternal and offspring vascular health. Participants will be recruited in the first trimester (T1, 10-12 weeks' gestation), and will be randomized to either a 24-week, structured and partially supervised, gym-based exercise intervention beginning in trimester 2 (T2) through to trimester 3 (T3), or a non-exercise control group who receive normal clinical care. The inclusion of this non-exercise control group is critical in allowing us to create an understanding of the adaptation of the vascular system during a normal (non-exercising) pregnancy, and also determining the physical activity and sedentary behaviour engaged in during normal healthy pregnancy. All participants will be asked to attend the laboratory at Liverpool John Moores University on 4 separate occasions synchronised with the end point of each trimester and then within four weeks of delivery. Maternal vascular health, physical activity, sedentary behaviour and fitness will be assessed during each time point throughout pregnancy while the fourth visit will comprise of an offspring vascular assessment. The investigators will also gain information on delivery outcomes including pre-term delivery, complications during labour, induction of labour, caesarean sections and post-partum haemorrhage via medical notes at the Liverpool Women's NHS Foundation Trust.

Interventions

OTHERExercise

Previously inactive pregnant women will be asked to complete 3-4 sessions of aerobic exercise each week for 24 weeks of 15-30 minutes in duration.

Sponsors

Liverpool Women's NHS Foundation Trust
CollaboratorOTHER
Liverpool John Moores University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

Collected data at each time point will be blinded to the outcome assessor.

Intervention model description

This study comprises of two groups; an exercise and a control group.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy pregnant female * No history of cardiovascular disease, gestational diabetes or pre-eclampsia * Single gestation * Not on medication affecting cardiovascular health * A non-smoker for at least 6 months * Participating in structured exercise \<twice/week * BMI \<30kg/m\^2 -

Exclusion criteria

* Royal College of Obstetricians and Gynaecologists (RCOG) contraindications for pregnancy * Pregnant by in-vitro fertilisation (IVF)exercise * BMI \>30kg/m\^2 * \>45 years old * Structured exercise \>twice/week * Multiple gestation * Disability preventing ambulation * Currently smoking or smoking within past 6 months prior to pregnancy * Non-English speaking women

Design outcomes

Primary

MeasureTime frameDescription
Change in Vascular FunctionChange from baseline at week 24 and 36 of pregnancyVascular function will be measured via endothelial-dependent flow-mediated dilation (FMD) of the brachial and femoral arteries and reported as percentage change.

Secondary

MeasureTime frameDescription
Change in Sedentary behaviourChange from baseline at week 24 and 36 of pregnancySedentary behaviour will be measured using an inclinometer at the end of each trimester for a period of 7 days in line with the accelerometer monitoring and will be reported in minutes.
Change in Physical activityChange from baseline at week 24 and 36 of pregnancyPhysical activity will be monitored for a period of 7 days using accelerometry at the end of each trimester.
Incidence of Pregnancy specific outcomesFollowing delivery and within 4 weeksFollowing delivery the investigator will obtain information regarding pregnancy specific outcomes including pre-term birth, delivery complications, induction of labour, caesarean section and post-partum haemorrhage via medical notes at the collaborating hospital.

Other

MeasureTime frameDescription
Change in Cerebrovascular FunctionChange from baseline at week 24 and 36 of pregnancyChange in cerebrovascular function will be assessed using transcranial Doppler ultrasound to measure brain blood flow velocity.
Change in Vascular StructureChange from baseline at week 24 and 36 of pregnancyVascular structure will be measured at carotid, femoral and brachial arteries using ultrasound imaging to clearly visualise the artery. The image will be adjusted so that artery wall thickness can be clearly seen and a 30 second recording taken at three different angles. The average of the three angles will be calculated for each artery. Results will be reported as change in millimetres at each time point for each artery assessed.
Offspring Vascular StructureAssessed within 4 weeks of deliveryOffspring vascular structure will be assessed at the abdominal aorta site using ultrasound imaging. Wall thickness will be measured at three different angles of an optimised ultrasound image. The image will be adjusted so that artery wall thickness can be clearly seen and a 30 second recording taken at three different angles. The average of the three angles will be calculated for each artery. Results will be reported as change in millimetres at each time point for each artery assessed.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026