Physical Activity and Vascular Health During Pregnancy

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

Detailed Description
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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.

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

Conditions
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Pregnant, Sedentary Lifestyle

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study comprises of two groups; an exercise and a control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Participants randomized to the exercise intervention group will be required to complete a 24-wk partially supervised exercise programme consisting of 3-4 sessions per week of 15 minutes progressing to 30 minutes over time. | Other: Exercise<br>* 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.<br>|
| No Intervention: Control<br>Those randomized to the control group will continue with their standard care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vascular Function | Vascular function will be measured via endothelial-dependent flow-mediated dilation (FMD) of the brachial and femoral arteries and reported as percentage change. | Change from baseline at week 24 and 36 of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sedentary behaviour | Sedentary 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 from baseline at week 24 and 36 of pregnancy | 
| Change in Physical activity | Physical activity will be monitored for a period of 7 days using accelerometry at the end of each trimester. | Change from baseline at week 24 and 36 of pregnancy | 
| Incidence of Pregnancy specific outcomes | Following 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. | Following delivery and within 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular structure, vascular function, cerebrovascular reactivity, physical activity, sedentary behaviour, offspring health, maternal health