Physical Activity and Vascular Health During Pregnancy

Sedentary Lifestyle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03079258
• Other study ID #: 17/NW/0056
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 23, 2017
• Est. completion date: August 3, 2019

Study information

• Verified date: February 2019
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 3, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnant
• Sedentary Lifestyle

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Research Institute for Sport and Exercise Sciences (RISES)	Liverpool	Merseyside

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool John Moores University	Liverpool Women's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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