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Exercise in Pregnancy Evaluative Controlled Study (EXPECT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02503995
First Posted: July 21, 2015
Last Update Posted: July 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Michael Lewis, Swansea University
  Purpose
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.

Condition Intervention
Pregnancy Behavioral: Physical Exercise Participation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Influence of Regular Antenatal Physical Exercise on Cardiovascular, Haemodynamic and Autonomic Nervous System (CHANS) Function During and After Pregnancy

Resource links provided by NLM:


Further study details as provided by Dr Michael Lewis, Swansea University:

Primary Outcome Measures:
  • Heart Rate Variability - Time Point 1 [ Time Frame: 10-12 weeks gestation ]
    Determined from 3-lead ECG, assessed as absolute value

  • Heart Rate Variability - Time Point 2 [ Time Frame: 24-28 weeks gestation ]
    Determined from 3-lead ECG, assessed as absolute value

  • Heart Rate Variability - Time Point 3 [ Time Frame: 34-36 weeks gestation ]
    Determined from 3-lead ECG, assessed as absolute value

  • Heart Rate Variability - Time Point 4 [ Time Frame: 12 weeks post-birth ]
    Determined from 3-lead ECG, assessed as absolute value

  • Cardiac Stroke Volume - Time Point 1 [ Time Frame: 10-12 weeks gestation ]
    Determined from thoracic impedance cardiogram, assessed as absolute value

  • Cardiac Stroke Volume - Time Point 2 [ Time Frame: 24-28 weeks gestation ]
    Determined from thoracic impedance cardiogram, assessed as absolute value

  • Cardiac Stroke Volume - Time Point 3 [ Time Frame: 34-36 weeks gestation ]
    Determined from thoracic impedance cardiogram, assessed as absolute value

  • Cardiac Stroke Volume - Time Point 4 [ Time Frame: 12 weeks post-birth ]
    Determined from thoracic impedance cardiogram, assessed as absolute value


Enrollment: 90
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503995


Sponsors and Collaborators
Swansea University
Investigators
Study Director: Simon J Emery, MB BCh Abertawe Bro Morgannwg University Health Board