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Completed

NCT Number: NCT02503995

Exercise in Pregnancy Evaluative Controlled Study

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.

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Exercise Participation

Behavioral

Primary outcomes

  1. Heart Rate Variability - Time Point 1

    Time frame: 10-12 weeks gestation

    Determined from 3-lead ECG, assessed as absolute value

  2. Heart Rate Variability - Time Point 2

    Time frame: 24-28 weeks gestation

    Determined from 3-lead ECG, assessed as absolute value

  3. Heart Rate Variability - Time Point 3

    Time frame: 34-36 weeks gestation

    Determined from 3-lead ECG, assessed as absolute value

  4. Heart Rate Variability - Time Point 4

    Time frame: 12 weeks post-birth

    Determined from 3-lead ECG, assessed as absolute value

  5. Cardiac Stroke Volume - Time Point 1

    Time frame: 10-12 weeks gestation

    Determined from thoracic impedance cardiogram, assessed as absolute value

  6. Cardiac Stroke Volume - Time Point 2

    Time frame: 24-28 weeks gestation

    Determined from thoracic impedance cardiogram, assessed as absolute value

  7. Cardiac Stroke Volume - Time Point 3

    Time frame: 34-36 weeks gestation

    Determined from thoracic impedance cardiogram, assessed as absolute value

  8. Cardiac Stroke Volume - Time Point 4

    Time frame: 12 weeks post-birth

    Determined from thoracic impedance cardiogram, assessed as absolute value

Sponsors and collaborators

Lead sponsor

Swansea University

Other

Registry information

Official study title

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

Acronym: EXPECT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 21, 2015
Registry last updated
Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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