Exercise in Pregnancy Evaluative Controlled Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Behavioral: Physical Exercise Participation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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