Clinical trial NCT03079258: Physical Activity and Vascular Health During Pregnancy
Official title: Can Physical Activity During Pregnancy Improve Maternal and Offspring Vascular Health?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnant
Sedentary Lifestyle
Keywords: vascular structure
vascular function
cerebrovascular reactivity
physical activity
sedentary behaviour
offspring health
maternal health
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Liverpool Women's NHS Foundation Trust
First posted: 2017-03-14
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study comprises of two groups; an exercise and a control group.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Vascular Function
timeFrame: Change from baseline at week 24 and 36 of pregnancy
Secondary outcomes:
measure: Change in Sedentary behaviour
timeFrame: Change from baseline at week 24 and 36 of pregnancy
measure: Change in Physical activity
timeFrame: Change from baseline at week 24 and 36 of pregnancy
measure: Incidence of Pregnancy specific outcomes
timeFrame: Following delivery and within 4 weeks
Other outcomes:
measure: Offspring Vascular Structure
timeFrame: Assessed within 4 weeks of delivery
measure: Change in Cerebrovascular Function
timeFrame: Change from baseline at week 24 and 36 of pregnancy
measure: Change in Vascular Structure
timeFrame: Change from baseline at week 24 and 36 of pregnancy
Locations:
city: Liverpool
country: United Kingdom
facility: Research Institute for Sport and Exercise Sciences (RISES)
state: Merseyside
Study officials:
affiliation: Dr.
name: Nicola Hopkins, PhD
role: STUDY_DIRECTOR
References:
citation: Brislane A, Jones H, Holder SM, Low DA, Hopkins ND. The Effect of Exercise During Pregnancy on Maternal and Offspring Vascular Outcomes: a Pilot Study. Reprod Sci. 2021 Feb;28(2):510-523. doi: 10.1007/s43032-020-00302-7. Epub 2020 Nov 30.