Physical Exercise Cardiovascular Adaptation Monitoring in Pregnancy (PE-CAMP Study)
- Conditions
- Pregnancy RelatedMaternal-Fetal RelationsPregnant Women
- Interventions
- Behavioral: Exercise group
- Registration Number
- NCT03748888
- Lead Sponsor
- Swansea University
- Brief 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 138
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise group Exercise group An antenatal physical activity (APA) programme will be designed for participants in the exercise group.
- Primary Outcome Measures
Name Time Method Changes in maternal cardiac output during and after pregnancy. 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. 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.
Foetal heart rate 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.
Changes in maternal heart rate variability during and after pregnancy 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.
- Secondary Outcome Measures
Name Time Method Changes in active pregnant women energy expenditure 18 and 36 weeks pregnancy. Data obtained from accelerometer devices worn by exercise group participants.
Changes in sedentary pregnant women energy expenditure 18 and 36 weeks pregnancy. Data obtained from accelerometer devices worn by control group participants.
Energy expenditure during the early postpartum period. 12 weeks postpartum. Data obtained from accelerometer devices worn by all participants in the study.
Gestational weight gain. 36 weeks pregnancy. Weight gain during pregnancy measured in kilograms would be recorded to be compared in between study groups.
Changes in maternal body fat percentage during pregnancy. 18 and 36 weeks pregnancy. Body fat percentage calculated from skinfold-thickness measures would be compared in between study groups.
Birth weight Second week after birth. Birth weight from new borns recorded in kilograms would be collected from maternal records. It would be analysed and compared between groups.
Results from Qol-Grav questionnaire during second and third trimester of pregnancy. 18 and 36 weeks 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.Pre-pregnancy physical activity levels recorded by the modified physical activity questionnaire. 12 weeks pregnancy. 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.
Changes in quality of sleep during pregnancy. 18 and 36 weeks of 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.
Sleep patterns in the three months old infant 12 weeks postpartum. 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.
Pregnancy physical activity levels during first trimester recorded by the modified physical activity questionnaire. 12 weeks pregnancy. 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.
Pregnancy physical activity levels during second and third trimester recorded by the modified physical activity questionnaire. 36 weeks pregnancy. 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.
Quality of sleep during postpartum. 12 weeks 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.
Trial Locations
- Locations (1)
Singleton Hospital, Maternity Unit
🇬🇧Swansea, United Kingdom