NCT03079258

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 23, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2019

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

2.1 years

First QC Date

February 28, 2017

Last Update Submit

February 27, 2019

Conditions

PregnantSedentary Lifestyle

Keywords

vascular structurevascular functioncerebrovascular reactivityphysical activitysedentary behaviouroffspring healthmaternal health

Outcome Measures

Primary Outcomes (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.

    Change from baseline at week 24 and 36 of pregnancy

Secondary Outcomes (3)

  • Change in Sedentary behaviour

    Change from baseline at week 24 and 36 of pregnancy

  • Change in Physical activity

    Change from baseline at week 24 and 36 of pregnancy

  • Incidence of Pregnancy specific outcomes

    Following delivery and within 4 weeks

Other Outcomes (3)

  • Offspring Vascular Structure

    Assessed within 4 weeks of delivery

  • Change in Cerebrovascular Function

    Change from baseline at week 24 and 36 of pregnancy

  • Change in Vascular Structure

    Change from baseline at week 24 and 36 of pregnancy

Study Arms (2)

Exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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.

Exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsDue to the topic of this study, this study targets female gender.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute for Sport and Exercise Sciences (RISES)

Liverpool, Merseyside, L33AF, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 33258064DERIVED

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nicola Hopkins, PhD

    Dr.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Collected data at each time point will be blinded to the outcome assessor.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study comprises of two groups; an exercise and a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Áine Brislane

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 14, 2017

Study Start

April 23, 2017

Primary Completion

May 30, 2019

Study Completion

August 3, 2019

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)