PregnancyEXPECTNCT02503995
Exercise in Pregnancy Evaluative Controlled Study
A study testing Physical Exercise Participation in people with Pregnancy, run by Swansea University.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Physical Exercise Participation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible participants were apparently healthy pregnant women aged 18 years or over, with no existing complications of pregnancy at their 12-week dating scan.
Who cannot join
- Exclusion criteria were: a history of cardiovascular or chronic respiratory problems, sleep apnoea, or central/peripheral nervous system disorder.
About this study
Official title: Influence of Regular Antenatal Physical Exercise on Cardiovascular, Haemodynamic and Autonomic Nervous System (CHANS) Function During and After Pregnancy
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Physical Exercise Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Exercise ParticipationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| No intervention | Active comparator | Participants not undertaking any additional exercise Receives: Behavioral: Physical Exercise Participation |
| Water-based exercise group | Experimental | Participants assigned to a water-based exercise group Receives: Behavioral: Physical Exercise Participation |
| Land-based exercise group | Experimental | Participants assigned to a land-based exercise group Receives: Behavioral: Physical Exercise Participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability - Time Point 1
Determined from 3-lead ECG, assessed as absolute value
Measured: 10-12 weeks gestation
Heart Rate Variability - Time Point 2
Determined from 3-lead ECG, assessed as absolute value
Measured: 24-28 weeks gestation
Heart Rate Variability - Time Point 3
Determined from 3-lead ECG, assessed as absolute value
Measured: 34-36 weeks gestation
Heart Rate Variability - Time Point 4
Determined from 3-lead ECG, assessed as absolute value
Measured: 12 weeks post-birth
Cardiac Stroke Volume - Time Point 1
Determined from thoracic impedance cardiogram, assessed as absolute value
Measured: 10-12 weeks gestation
Cardiac Stroke Volume - Time Point 2
Determined from thoracic impedance cardiogram, assessed as absolute value
Measured: 24-28 weeks gestation
Cardiac Stroke Volume - Time Point 3
Determined from thoracic impedance cardiogram, assessed as absolute value
Measured: 34-36 weeks gestation
Cardiac Stroke Volume - Time Point 4
Determined from thoracic impedance cardiogram, assessed as absolute value
Measured: 12 weeks post-birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Michael Lewis, Swansea University
- Investigators
- Simon J Emery, MB BCh, Study director, Abertawe Bro Morgannwg University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503995
- Sponsor's protocol ID
- 12/WA/0081
- Acronym
- EXPECT
- Status last verified
- Jul 2015
- First submitted
- 10 Jul 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25690105D'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.
PubMed 24345774Carpenter 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.
PubMed 26296647
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Regular Antenatal Physical Exercise on Cardiovascular, Haemodynamic and Autonomic Nervous System (CHANS) Function During and After Pregnancy
- ClinicalTrials.gov ID
- NCT02503995
- Acronym / sponsor ID
- EXPECT / 12/WA/0081
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention | Active comparator | Behavioral: Physical Exercise ParticipationParticipants not undertaking any additional exercise |
| Water-based exercise group | Experimental | Behavioral: Physical Exercise ParticipationParticipants assigned to a water-based exercise group |
| Land-based exercise group | Experimental | Behavioral: Physical Exercise ParticipationParticipants assigned to a land-based exercise group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Eligible participants were apparently healthy pregnant women aged 18 years or over, with no existing complications of pregnancy at their 12-week dating scan.
Key exclusion criteria (1 listed)
- Exclusion criteria were: a history of cardiovascular or chronic respiratory problems, sleep apnoea, or central/peripheral nervous system disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Exercise Participation | Behavioural | Land-based exercise group, No intervention, Water-based exercise group |
Primary outcome
Heart Rate Variability - Time Point 1
Time frame: 10-12 weeks gestation
Determined from 3-lead ECG, assessed as absolute value
Heart Rate Variability - Time Point 2
Time frame: 24-28 weeks gestation
Determined from 3-lead ECG, assessed as absolute value
Heart Rate Variability - Time Point 3
Time frame: 34-36 weeks gestation
Determined from 3-lead ECG, assessed as absolute value
Heart Rate Variability - Time Point 4
Time frame: 12 weeks post-birth
Determined from 3-lead ECG, assessed as absolute value
Cardiac Stroke Volume - Time Point 1
Time frame: 10-12 weeks gestation
Determined from thoracic impedance cardiogram, assessed as absolute value
Cardiac Stroke Volume - Time Point 2
Time frame: 24-28 weeks gestation
Determined from thoracic impedance cardiogram, assessed as absolute value
Cardiac Stroke Volume - Time Point 3
Time frame: 34-36 weeks gestation
Determined from thoracic impedance cardiogram, assessed as absolute value
Cardiac Stroke Volume - Time Point 4
Time frame: 12 weeks post-birth
Determined from thoracic impedance cardiogram, assessed as absolute value
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- Results publication: PubMed 25690105Carpenter 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.
- Results publication: PubMed 24345774D'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.
- Derived from this study: PubMed 26296647Carpenter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon J Emery, MB BCh study director
Abertawe Bro Morgannwg University Health Board
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise Participation in people with Pregnancy, run by Swansea University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability - Time Point 1 (time frame: 10-12 weeks gestation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02503995, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.