Physical Activity and Vascular Health During Pregnancy

NCT ID: NCT03079258

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-23

Study Completion Date

2019-08-03

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.

Conditions

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Pregnant Sedentary Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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.

Control

Those randomized to the control group will continue with their standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Liverpool Women's NHS Foundation Trust

OTHER

Sponsor Role collaborator

Liverpool John Moores University

OTHER

Sponsor Role lead

Responsible Party

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Áine Brislane

Principal Investigator Áine Brislane

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicola Hopkins, PhD

Role: STUDY_DIRECTOR

Dr.

Locations

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Research Institute for Sport and Exercise Sciences (RISES)

Liverpool, Merseyside, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33258064 (View on PubMed)

Other Identifiers

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17/NW/0056

Identifier Type: -

Identifier Source: org_study_id

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