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PregnantNCT03079258

Physical Activity and Vascular Health During Pregnancy

A study testing Exercise in people with Pregnant and Sedentary Lifestyle, run by Liverpool John Moores University at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnant, Sedentary Lifestyle
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited Kingdom
Study dates
23 Apr 2017to 3 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 -

Who cannot join

  • 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
Show all 9Show fewer
  • Disability preventing ambulation
  • Currently smoking or smoking within past 6 months prior to pregnancy
  • Non-English speaking women

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Research Institute for Sport and Exercise Sciences (RISES)

    Liverpool, Merseyside, L33AF

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Exercise
Keywords
vascular structure, vascular function, cerebrovascular reactivity, physical activity, sedentary behaviour, offspring health, maternal health
Medical subject headings
Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    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.

Study groups in NCT03079258
Study groupRoleWhat they receive
ExerciseExperimentalParticipants 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.
Receives: Other: Exercise
ControlNo interventionThose randomized to the control group will continue with their standard care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline at week 24 and 36 of pregnancy

Secondary outcomes (3)

  1. 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.

    Measured: Change from baseline at week 24 and 36 of pregnancy

  2. Change in Physical activity

    Physical activity will be monitored for a period of 7 days using accelerometry at the end of each trimester.

    Measured: Change from baseline at week 24 and 36 of pregnancy

  3. 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.

    Measured: Following delivery and within 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2017
  2. Study start23 Apr 2017
  3. Primary completion30 May 2019 (estimated)
  4. Study completion3 Aug 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study comprises of two groups; an exercise and a control group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03079258
Sponsor's protocol ID
17/NW/0056
Status last verified
Feb 2019
First submitted
28 Feb 2017
Last updated
28 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 33258064

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Pregnant and Sedentary Lifestyle, run by Liverpool John Moores University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Vascular Function (time frame: Change from baseline at week 24 and 36 of pregnancy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03079258, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.

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