Physical Activity and Vascular Health During Pregnancy

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

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

Study Overview

• Status: Unknown
• Conditions: Sedentary Lifestyle; Pregnant
• Intervention / Treatment: Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L33AF
      • Research Institute for Sport and Exercise Sciences (RISES)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; 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; 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.
No Intervention: Control; Those randomized to the control group will continue with their standard care.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Offspring Vascular Structure	Offspring 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.	Assessed within 4 weeks of delivery
Change in Cerebrovascular Function	Change in cerebrovascular function will be assessed using transcranial Doppler ultrasound to measure brain blood flow velocity.	Change from baseline at week 24 and 36 of pregnancy
Change in Vascular Structure	Vascular 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.	Change from baseline at week 24 and 36 of pregnancy

Collaborators and Investigators

• Sponsor: Liverpool John Moores University
• Collaborators: Liverpool Women's NHS Foundation Trust
• Investigators: Study Director: Nicola Hopkins, PhD, Dr.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2017
• Primary Completion (Anticipated): May 30, 2019
• Study Completion (Anticipated): August 3, 2019

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; sedentary behaviour; vascular function; maternal health; cerebrovascular reactivity; vascular structure; offspring health
• Other Study ID Numbers: 17/NW/0056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No