Pregnancy RelatedPE-CAMPNCT03748888
Physical Exercise Cardiovascular Adaptation Monitoring in Pregnancy (PE-CAMP Study)
A study testing Exercise group in people with Pregnancy Related and Pregnant Women, run by Swansea University at 1 site in United Kingdom.
Trial summary
The main theme of this study focuses on providing evidence of the impact of antenatal physical activity on maternal/foetal cardiovascular changes during pregnancy and maternal cardiovascular adaptations during the early postpartum period. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Pregnant Women, Maternal-Fetal Relations
- What is being tested?
- Exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2018to 31 Dec 2021
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with healthy pregnancy
- Aged 18-40 years
- Single pregnancy
- Pregnancy stage <= 16 weeks' gestation at the point of consent.
- Two or fewer previous term pregnancies (as physiology can be altered by multiple pregnancies).
Who cannot join
- Known complications of pregnancy
- Known contraindications for physical exercise
- Known major cardiovascular or respiratory pathology
- Three or more previous term pregnancies
- Inability to communicate in English or Welsh.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Singleton Hospital, Maternity Unit
Swansea, SA2 8QA
About this study
Official title: Physical Exercise, Cardiovascular Adaptation Monitoring in Pregnancy
The main theme of this study focuses on providing evidence of the impact of antenatal physical activity on maternal/foetal cardiovascular changes during pregnancy and maternal cardiovascular adaptations during the early postpartum period.
Read the detailed description
Overwhelming research supports the general benefit of antenatal physical activity (APA) for pregnant women, but there is a lack of knowledge about the influence of exercise on cardiovascular physiology in healthy and overweight pregnant women and their foetuses. Also some research supports the theory of foetal programming; which establish that maternal habits during pregnancy will impact in-utero environment, so if this maternal habits are healthy ones they could improve foetal health.
Cardio vascular disease (CVD) was the top cause of death all over the world in 2015. In Wales CVD as cause of death is still one of the top ones. However, these statistics could be improved if people adopt healthier lifestyle habits, since 54% and 45% of Welsh women are overweight/obese or sedentary respectively. Pregnancy seems to be a teachable moment for women and the starting point of adopting healthy life-style habits. Therefore, by introducing Welsh pregnant women to exercise, there is the potential to improve their health and of their foetuses an also exert an exponential impact on future generations.
The main theme of this study focuses on providing evidence of the impact of APA on maternal/foetal cardiovascular changes during pregnancy and maternal cardiovascular adaptations during the early postpartum period.
This is a 3-year study carried out in Swansea University, Singleton Hospital.
The project leading to this application has received funding from the European Union's Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant agreement No 663830.
Healthy pregnant women with no contraindications for exercise will be eligible for the study and those who want to participate in the project will be allocated into an exercise group (EG) or a control group (CG). EG participants will receive an intervention based on an APA during 20-24weeks, CG participants will follow their standard health care during pregnancy.
All participants must attend three cardiovascular assessment protocols (18-22 weeks \& 32-36weeks during pregnancy, 12weeks postpartum). These protocols will involve maternal/foetal electrocardiograph and echocardiograph evaluation, heart-rate monitoring and moderate physical exercise (walking).
- Conditions
- Pregnancy Related, Pregnant Women, Maternal-Fetal Relations
- Being tested
- Exercise group
- Keywords
- Cardiovascular system, Antenatal physical activity, Maternal heart rate, Foetal heart rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupBehavioural
An antenatal physical activity (APA) programme will be designed for participants in the exercise group.
The APA will last for 20-24 weeks. Participants in the EG must enrol in the APA between their 12-16 weeks of gestation.
The APA programme has a frequency of three times a week, which involves aerobic, strength and stretching exercises. The intensity of the APA programme is individually calculated for each participant based on their pre-pregnancy fitness level. Single sessions of the APA programme last 50-60min.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | An antenatal physical activity (APA) programme will be designed for participants in the exercise group. Receives: Behavioral: Exercise group |
| Control Group | No intervention | Sedentary participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in maternal cardiac output during and after pregnancy.
Maternal cardiac output at rest, during exercise and after exercise measured in L/min would be recorded from study participants to analyse and compare potential changes inter and intra group.
Measured: 18 and 36 weeks of gestation, 12 weeks postpartum.
Changes in maternal heart rate during and after pregnancy.
Maternal heart rate at rest and after exercise would be recorded in beats per minute to be analysed and compared inter and intra group.
Measured: 18 and 36 weeks of gestation, 12 weeks postpartum.
Changes in maternal heart rate variability during and after pregnancy
Maternal heart rate variability at rest, during and after exercise would be measured by r to r interval. It would be recorded and analysed to compare inter and intra group changes.
Measured: 18 and 36 weeks of gestation, 12 weeks postpartum.
Foetal heart rate
Foetal heart rate baseline would be measured at rest, during and after exercise. It would be analysed and compared in between groups.
Measured: 36 weeks pregnancy
Secondary outcomes (13)
Changes in active pregnant women energy expenditure
Data obtained from accelerometer devices worn by exercise group participants.
Measured: 18 and 36 weeks pregnancy.
Changes in sedentary pregnant women energy expenditure
Data obtained from accelerometer devices worn by control group participants.
Measured: 18 and 36 weeks pregnancy.
Energy expenditure during the early postpartum period.
Data obtained from accelerometer devices worn by all participants in the study.
Measured: 12 weeks postpartum.
Gestational weight gain.
Weight gain during pregnancy measured in kilograms would be recorded to be compared in between study groups.
Measured: 36 weeks pregnancy.
Changes in maternal body fat percentage during pregnancy.
Body fat percentage calculated from skinfold-thickness measures would be compared in between study groups.
Measured: 18 and 36 weeks pregnancy.
Birth weight
Birth weight from new borns recorded in kilograms would be collected from maternal records. It would be analysed and compared between groups.
Measured: Second week after birth.
Results from Qol-Grav questionnaire during second and third trimester of pregnancy.
The Qol-Grav questionnaire is a validated questionnaire used to measure quality of life in pregnant women. This questionnaire would be filled in by study participants and analysed to record their quality of life during the current pregnancy. Scores derived from the questionnaire would be analysed and compared between groups.
The following total score scale is presented:
9-18: Excellent quality of life. 19-27: Very good quality of life. 28-36: Good quality of life. 37-45: Not very good quality of life.
Measured: 18 and 36 weeks pregnancy.
Pre-pregnancy physical activity levels recorded by the modified physical activity questionnaire.
Participants' pre-pregnancy physical activity levels would be registered using the modified physical activity questionnaire. This questionnaire records information about activities performed for the three months before pregnancy. Intensity of the activity would be recorded using three different levels of intensity (low, moderate and vigorous). Average time spent in each activity would be recorded in minutes. These values would be used to measure time and intensity spent in physical activity before pregnancy, and would be compared between groups.
Measured: 12 weeks pregnancy.
Pregnancy physical activity levels during first trimester recorded by the modified physical activity questionnaire.
Participants' physical activity levels during the first trimester of pregnancy would be registered using the modified physical activity questionnaire. This questionnaire records information about activities performed during the first three months of pregnancy. Intensity of the activity would be recorded using three different levels of intensity (low, moderate and vigorous). Average time spent in each activity would be recorded in minutes. These values would be used to measure time and intensity spent in physical activity during pregnancy, and would be compared between groups.
Measured: 12 weeks pregnancy.
Pregnancy physical activity levels during second and third trimester recorded by the modified physical activity questionnaire.
Participants' physical activity levels during the second and third trimester of pregnancy would be registered using the modified physical activity questionnaire. This questionnaire records information about activities performed during the second an third trimesters of pregnancy. Intensity of the activity would be recorded using three different levels of intensity (low, moderate and vigorous). Average time spent in each activity would be recorded in minutes. These values would be used to measure time and intensity spent in physical activity during pregnancy, and would be compared between groups.
Measured: 36 weeks pregnancy.
Changes in quality of sleep during pregnancy.
Two questionnaires would be used to measure participants' quality of sleep during their pregnancy. These questionnaires are the Pittsburgh Sleep Quality Index and the Insomnia Severity Index.
Measured: 18 and 36 weeks of pregnancy.
Quality of sleep during postpartum.
Two questionnaires would be used to measure participants' quality of sleep during the postpartum period. These questionnaires are the Pittsburgh Sleep Quality Index and the Insomnia Severity Index.
Measured: 12 weeks postpartum.
Sleep patterns in the three months old infant
The Brief Screening Questionnaire for Infant Sleep Problems would be used to register sleep patterns in the three months old infants born from study participants. Items recorded in the questionnaire are the following: sleep arrangement, time spent sleeping during the day and night, number of wakings per night, mode of falling asleep, time spent in wakefulness and normal time of falling asleep at night.
Measured: 12 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start26 Apr 2018
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Model description
- The present study will involve two study groups. 1. Exercise group (EG). Pregnant women allocated in the EG will receive and intervention based on a supervised antenatal physical activity programme during 20-24 weeks. They must be enrolled in the study between their 12-16 weeks of gestation. 2. Control group (CG). Pregnant women allocated in CG will not receive any intervention. They will maintain standard health care during pregnancy.
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, Olga Roldan-Reoyo, Swansea University
- Investigators
- MICHAEL J LEWIS, Prof, Study chair, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748888
- Sponsor's protocol ID
- 663830-SU-079
- Other IDs
- 17/WA/0414
- Acronym
- PE-CAMP
- Status last verified
- Oct 2022
- First submitted
- 13 Nov 2018
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carpenter RE, Emery SJ, Uzun O, Rassi D, Lewis MJ. Influence of physical exercise on baroreceptor sensitivity during pregnancy. J Matern Fetal Neonatal Med. 2017 Mar;30(5):514-519. doi: 10.1080/14767058.2016.1179275. Epub 2016 May 12.
PubMed 27098455Carpenter 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 25690105
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise, Cardiovascular Adaptation Monitoring in Pregnancy
- ClinicalTrials.gov ID
- NCT03748888
- Acronym / sponsor ID
- PE-CAMP / 663830-SU-079
- Conditions
- Pregnancy Related, Pregnant Women, Maternal-Fetal Relations
- Keywords
- Cardiovascular system, Antenatal physical activity, Maternal heart rate, Foetal heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Nov 2018 (actual)
- 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.
The main theme of this study focuses on providing evidence of the impact of antenatal physical activity on maternal/foetal cardiovascular changes during pregnancy and maternal cardiovascular adaptations during the early postpartum period.
Detailed description
Overwhelming research supports the general benefit of antenatal physical activity (APA) for pregnant women, but there is a lack of knowledge about the influence of exercise on cardiovascular physiology in healthy and overweight pregnant women and their foetuses. Also some research supports the theory of foetal programming; which establish that maternal habits during pregnancy will impact in-utero environment, so if this maternal habits are healthy ones they could improve foetal health.
Cardio vascular disease (CVD) was the top cause of death all over the world in 2015. In Wales CVD as cause of death is still one of the top ones. However, these statistics could be improved if people adopt healthier lifestyle habits, since 54% and 45% of Welsh women are overweight/obese or sedentary respectively. Pregnancy seems to be a teachable moment for women and the starting point of adopting healthy life-style habits. Therefore, by introducing Welsh pregnant women to exercise, there is the potential to improve their health and of their foetuses an also exert an exponential impact on future generations.
The main theme of this study focuses on providing evidence of the impact of APA on maternal/foetal cardiovascular changes during pregnancy and maternal cardiovascular adaptations during the early postpartum period.
This is a 3-year study carried out in Swansea University, Singleton Hospital.
The project leading to this application has received funding from the European Union's Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant agreement No 663830.
Healthy pregnant women with no contraindications for exercise will be eligible for the study and those who want to participate in the project will be allocated into an exercise group (EG) or a control group (CG). EG participants will receive an intervention based on an APA during 20-24weeks, CG participants will follow their standard health care during pregnancy.
All participants must attend three cardiovascular assessment protocols (18-22 weeks \& 32-36weeks during pregnancy, 12weeks postpartum). These protocols will involve maternal/foetal electrocardiograph and echocardiograph evaluation, heart-rate monitoring and moderate physical exercise (walking).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The present study will involve two study groups. 1. Exercise group (EG). Pregnant women allocated in the EG will receive and intervention based on a supervised antenatal physical activity programme during 20-24 weeks. They must be enrolled in the study between their 12-16 weeks of gestation. 2. Control group (CG). Pregnant women allocated in CG will not receive any intervention. They will maintain standard health care during pregnancy.
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Exercise groupAn antenatal physical activity (APA) programme will be designed for participants in the exercise group. |
| Control Group | No intervention | –Sedentary participants. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with healthy pregnancy
- Aged 18-40 years
- Single pregnancy
- Pregnancy stage <= 16 weeks' gestation at the point of consent.
- Two or fewer previous term pregnancies (as physiology can be altered by multiple pregnancies).
Key exclusion criteria (5 listed)
- Known complications of pregnancy
- Known contraindications for physical exercise
- Known major cardiovascular or respiratory pathology
- Three or more previous term pregnancies
- Inability to communicate in English or Welsh.
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 |
|---|---|---|
| Exercise groupAn antenatal physical activity (APA) programme will be designed for participants in the exercise group. The APA will last for 20-24 weeks. Participants in the EG must enrol in the APA between their 12-16 weeks of gestation. The APA programme has a frequency of three times a week, which involves aerobic, strength and stretching exercises. The intensity of the APA programme is individually calculated for each participant based on their pre-pregnancy fitness level. Single sessions of the APA programme last 50-60min. | Behavioural | Exercise group |
Primary outcome
Changes in maternal cardiac output during and after pregnancy.
Time frame: 18 and 36 weeks of gestation, 12 weeks postpartum.
Maternal cardiac output at rest, during exercise and after exercise measured in L/min would be recorded from study participants to analyse and compare potential changes inter and intra group.
Changes in maternal heart rate during and after pregnancy.
Time frame: 18 and 36 weeks of gestation, 12 weeks postpartum.
Maternal heart rate at rest and after exercise would be recorded in beats per minute to be analysed and compared inter and intra group.
Changes in maternal heart rate variability during and after pregnancy
Time frame: 18 and 36 weeks of gestation, 12 weeks postpartum.
Maternal heart rate variability at rest, during and after exercise would be measured by r to r interval. It would be recorded and analysed to compare inter and intra group changes.
Foetal heart rate
Time frame: 36 weeks pregnancy
Foetal heart rate baseline would be measured at rest, during and after exercise. It would be analysed and compared in between groups.
13 secondary outcomes
Changes in active pregnant women energy expenditure
Time frame: 18 and 36 weeks pregnancy.
Changes in sedentary pregnant women energy expenditure
Time frame: 18 and 36 weeks pregnancy.
Energy expenditure during the early postpartum period.
Time frame: 12 weeks postpartum.
Gestational weight gain.
Time frame: 36 weeks pregnancy.
Changes in maternal body fat percentage during pregnancy.
Time frame: 18 and 36 weeks pregnancy.
Birth weight
Time frame: Second week after birth.
Results from Qol-Grav questionnaire during second and third trimester of pregnancy.
Time frame: 18 and 36 weeks pregnancy.
Pre-pregnancy physical activity levels recorded by the modified physical activity questionnaire.
Time frame: 12 weeks pregnancy.
Pregnancy physical activity levels during first trimester recorded by the modified physical activity questionnaire.
Time frame: 12 weeks pregnancy.
Pregnancy physical activity levels during second and third trimester recorded by the modified physical activity questionnaire.
Time frame: 36 weeks pregnancy.
Changes in quality of sleep during pregnancy.
Time frame: 18 and 36 weeks of pregnancy.
Quality of sleep during postpartum.
Time frame: 12 weeks postpartum.
Sleep patterns in the three months old infant
Time frame: 12 weeks postpartum.
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 26 Oct 2022.
- Results publication: PubMed 27098455Carpenter RE, Emery SJ, Uzun O, Rassi D, Lewis MJ. Influence of physical exercise on baroreceptor sensitivity during pregnancy. J Matern Fetal Neonatal Med. 2017 Mar;30(5):514-519. doi: 10.1080/14767058.2016.1179275. Epub 2016 May 12.
- 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.
- Individual participant dataSharing planned: No
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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.
MICHAEL J LEWIS, Prof study chair
Swansea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise group in people with Pregnancy Related and Pregnant Women, run by Swansea University at 1 site in United Kingdom.
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 5 inclusion and 5 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 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Changes in maternal cardiac output during and after pregnancy. (time frame: 18 and 36 weeks of gestation, 12 weeks postpartum.). The study lists 4 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 NCT03748888, which also lists 2 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 26 Oct 2022.