Exercise in Pregnancy Evaluative Controlled Study (EXPECT)

July 20, 2015 updated by: Dr Michael Lewis, Swansea University

Influence of Regular Antenatal Physical Exercise on Cardiovascular, Haemodynamic and Autonomic Nervous System (CHANS) Function During and After Pregnancy

This study aimed to investigate whether there are measurable differences in CHANS function in pregnant women who receive only standard antenatal care compared with those who additionally undertake a programme of regular physical exercise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The health benefits of physical exercise in the non-pregnant population are generally appreciated but its influence during pregnancy has not been clearly demonstrated. The focus of this proposal is to obtain for the first time a comprehensive understanding of the influence of regular physical exercise during pregnancy on cardiovascular, haemodynamic and autonomic nervous system (CHANS) parameters during pregnancy and following childbirth. This will involve assessing heart rate variability and cardiac stroke volume. This study will allow the investigators to compare CHANS parameters in pregnant women who are randomly assigned into three groups: a 'standard care' group and two groups who engage in a supervised programme of physical exercise (either land-based or water-based). The investigators will assess CHANS parameters at three stages during pregnancy and on one occasion following childbirth. This will allow the influence of regular (weekly) physical exercise on CHANS physiology to be assessed during advancing gestation. The investigators will thus use this study to provide initial evidence of the health benefits of regular and specific forms of antenatal physical exercise.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Eligible participants were apparently healthy pregnant women aged 18 years or over, with no existing complications of pregnancy at their 12-week dating scan.

Exclusion Criteria:

  • Exclusion criteria were: a history of cardiovascular or chronic respiratory problems, sleep apnoea, or central/peripheral nervous system disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: No intervention
Participants not undertaking any additional exercise
Behavioral: Physical Exercise Participation
Experimental: Water-based exercise group
Participants assigned to a water-based exercise group
Behavioral: Physical Exercise Participation
Experimental: Land-based exercise group
Participants assigned to a land-based exercise group
Behavioral: Physical Exercise Participation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability - Time Point 1
Time Frame: 10-12 weeks gestation
Determined from 3-lead ECG, assessed as absolute value
10-12 weeks gestation
Heart Rate Variability - Time Point 2
Time Frame: 24-28 weeks gestation
Determined from 3-lead ECG, assessed as absolute value
24-28 weeks gestation
Heart Rate Variability - Time Point 3
Time Frame: 34-36 weeks gestation
Determined from 3-lead ECG, assessed as absolute value
34-36 weeks gestation
Heart Rate Variability - Time Point 4
Time Frame: 12 weeks post-birth
Determined from 3-lead ECG, assessed as absolute value
12 weeks post-birth
Cardiac Stroke Volume - Time Point 1
Time Frame: 10-12 weeks gestation
Determined from thoracic impedance cardiogram, assessed as absolute value
10-12 weeks gestation
Cardiac Stroke Volume - Time Point 2
Time Frame: 24-28 weeks gestation
Determined from thoracic impedance cardiogram, assessed as absolute value
24-28 weeks gestation
Cardiac Stroke Volume - Time Point 3
Time Frame: 34-36 weeks gestation
Determined from thoracic impedance cardiogram, assessed as absolute value
34-36 weeks gestation
Cardiac Stroke Volume - Time Point 4
Time Frame: 12 weeks post-birth
Determined from thoracic impedance cardiogram, assessed as absolute value
12 weeks post-birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swansea University

Investigators

  • Study Director: Simon J Emery, MB BCh, Abertawe Bro Morgannwg University Health Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 10, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 12/WA/0081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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