Exercise in Pregnancy Evaluative Controlled Study

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Behavioral: Physical Exercise Participation

• Registration Number: NCT02503995
• Lead Sponsor: Swansea University

Brief Summary

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.

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 Timeline

• Study Start: 2012-03
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-07
• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2015-07-17
• Last Update Submitted: 2015-07-20
• Study First Posted: 2015-07-21
• Last Update Posted: 2015-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Land-based exercise group	Physical Exercise Participation	Participants assigned to a land-based exercise group
No intervention	Physical Exercise Participation	Participants not undertaking any additional exercise
Water-based exercise group	Physical Exercise Participation	Participants assigned to a water-based exercise group

Primary Outcome Measures

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