Physical Exercise Cardiovascular Adaptation Monitoring in Pregnancy (PE-CAMP Study)

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

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-26

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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

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Pregnancy Related Pregnant Women Maternal-Fetal Relations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Exercise group

An antenatal physical activity (APA) programme will be designed for participants in the exercise group.

Group Type EXPERIMENTAL

Exercise group

Intervention Type BEHAVIORAL

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.

Control Group

Sedentary participants.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Women with healthy pregnancy
2. Aged 18-40 years
3. Single pregnancy
4. Pregnancy stage \<= 16 weeks' gestation at the point of consent.
5. Two or fewer previous term pregnancies (as physiology can be altered by multiple pregnancies).

Exclusion Criteria

1. Known complications of pregnancy
2. Known contraindications for physical exercise
3. Known major cardiovascular or respiratory pathology
4. Three or more previous term pregnancies
5. Inability to communicate in English or Welsh.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes