Exercise in Pregnancy Evaluative Controlled Study

Pregnancy Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503995
• Other study ID #: 12/WA/0081
• Status: Completed
• Phase: N/A
• First received: July 10, 2015
• Last updated: July 20, 2015
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2015
• Source: Swansea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pregnancy

Intervention

Behavioral:
• Physical Exercise Participation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Swansea University

References & Publications (2)

Carpenter RE, D'Silva LA, Emery SJ, Uzun O, Rassi D, Lewis MJ. Changes in heart rate variability and QT variability during the first trimester of pregnancy. Physiol Meas. 2015 Mar;36(3):531-45. doi: 10.1088/0967-3334/36/3/531. Epub 2015 Feb 18. — View Citation

D'Silva LA, Davies RE, Emery SJ, Lewis MJ. Influence of somatic state on cardiovascular measurements in pregnancy. Physiol Meas. 2014 Jan;35(1):15-29. doi: 10.1088/0967-3334/35/1/15. Epub 2013 Dec 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability - Time Point 1	Determined from 3-lead ECG, assessed as absolute value	10-12 weeks gestation	No
Primary	Heart Rate Variability - Time Point 2	Determined from 3-lead ECG, assessed as absolute value	24-28 weeks gestation	No
Primary	Heart Rate Variability - Time Point 3	Determined from 3-lead ECG, assessed as absolute value	34-36 weeks gestation	No
Primary	Heart Rate Variability - Time Point 4	Determined from 3-lead ECG, assessed as absolute value	12 weeks post-birth	No
Primary	Cardiac Stroke Volume - Time Point 1	Determined from thoracic impedance cardiogram, assessed as absolute value	10-12 weeks gestation	No
Primary	Cardiac Stroke Volume - Time Point 2	Determined from thoracic impedance cardiogram, assessed as absolute value	24-28 weeks gestation	No
Primary	Cardiac Stroke Volume - Time Point 3	Determined from thoracic impedance cardiogram, assessed as absolute value	34-36 weeks gestation	No
Primary	Cardiac Stroke Volume - Time Point 4	Determined from thoracic impedance cardiogram, assessed as absolute value	12 weeks post-birth	No