Exercise in Pregnancy Evaluative Controlled Study

NCT ID: NCT02503995

Last Updated: 2015-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-05-31

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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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No intervention

Participants not undertaking any additional exercise

Group Type ACTIVE_COMPARATOR

Physical Exercise Participation

Intervention Type BEHAVIORAL

Water-based exercise group

Participants assigned to a water-based exercise group

Group Type EXPERIMENTAL

Physical Exercise Participation

Intervention Type BEHAVIORAL

Land-based exercise group

Participants assigned to a land-based exercise group

Group Type EXPERIMENTAL

Physical Exercise Participation

Intervention Type BEHAVIORAL

Interventions

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Physical Exercise Participation

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Swansea University

OTHER

Sponsor Role lead

Responsible Party

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Dr Michael Lewis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon J Emery, MB BCh

Role: STUDY_DIRECTOR

Abertawe Bro Morgannwg University Health Board

References

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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.

Reference Type RESULT
PMID: 25690105 (View on PubMed)

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.

Reference Type RESULT
PMID: 24345774 (View on PubMed)

Carpenter RE, Emery SJ, Uzun O, D'Silva LA, Lewis MJ. Influence of antenatal physical exercise on haemodynamics in pregnant women: a flexible randomisation approach. BMC Pregnancy Childbirth. 2015 Aug 22;15:186. doi: 10.1186/s12884-015-0620-2.

Reference Type DERIVED
PMID: 26296647 (View on PubMed)

Other Identifiers

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12/WA/0081

Identifier Type: -

Identifier Source: org_study_id

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