NCT02503995

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Mar 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

July 10, 2015

Last Update Submit

July 20, 2015

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (3)

No intervention

ACTIVE COMPARATOR

Participants not undertaking any additional exercise

Behavioral: Physical Exercise Participation

Water-based exercise group

EXPERIMENTAL

Participants assigned to a water-based exercise group

Behavioral: Physical Exercise Participation

Land-based exercise group

EXPERIMENTAL

Participants assigned to a land-based exercise group

Behavioral: Physical Exercise Participation

Interventions

Physical Exercise ParticipationBEHAVIORAL
Land-based exercise groupNo interventionWater-based exercise group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Eligible participants were apparently healthy pregnant women aged 18 years or over, with no existing complications of pregnancy at their 12-week dating scan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 25690105RESULT

  • 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.

    PMID: 24345774RESULT

  • 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.

    PMID: 26296647DERIVED

Study Officials

  • Simon J Emery, MB BCh

    Abertawe Bro Morgannwg University Health Board

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 10, 2015

First Posted

July 21, 2015

Study Start

March 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 22, 2015

Record last verified: 2015-07