Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03517293 |
| Other study ID # |
12-002524 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2015 |
| Est. completion date |
January 30, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
East Carolina University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
AHA and ACSM recognize lack of exercise is a major risk factor for developing cardiovascular
disease (CVD), and other CVD risk factors such as obesity. It is important to note that CVD
is the sixth leading cause of death and children are more likely to be undiagnosed due to
their age and lack of symptoms. Further, according to the CDC, over one-third of children and
adolescents are overweight or obese and at increased risk of CVD. Although many programs for
children aim to decrease CVD risks and obesity few, if any, programs begin the intervention
during prenatal development. Our preliminary findings suggest that regular maternal exercise
improves cardiovascular health (lower heart rate, increased heart rate variability),
normalizes body fat composition, and improves nervous system and motor tone even after birth.
Norepinephrine is essential for fetal development, influences many tissues (heart, nerve
cells, skeletal muscle, and fat cells), and can stimulate growth factors. It is believed that
exercise hormones, such as norepinephrine, released during maternal exercise influence these
growth factors during development.
The central hypothesis of this proposal is that regular maternal exercise during pregnancy
will improve the health of offspring before and after birth as evidenced by lower resting
heart rate, increasing heart rate variability improved neurological maturation, and decreased
adiposity. We have three specific aims to test this hypothesis through the Enhanced Neonatal
Health and Neonatal Cardiovascular Efficiency Developmentally (ENHANCED) by Mom project (IRB
approved #12-002524). Aim 1 will establish the association between maternal exercise during
pregnancy and the heart health of offspring before and after birth. Aim 2 will determine the
relationship between modes of regular maternal exercise and neonate neurological and muscular
maturation as this relates to health of the child after birth. Aim 3 will elucidate the
influence of different modes of maternal exercise during pregnancy on fetal and infant body
composition as this relates to risk of obesity and CVD disease. These studies will provide
novel insight into how different types of maternal exercise during pregnancy influence the
overall health of offspring. Furthermore, these findings may have significant implications on
the public health as it may provide evidence of pregnancy as the earliest intervention for
attenuating cardiovascular disease risk of children.
Description:
Recent studies have shown alarming increases in some of the major modifiable risk factors for
heart disease (cholesterol, blood pressure, adiposity) in young children. We have previously
found an association between self-reported exercise during pregnancy and improved heart
measures of the fetus and neonate. In addition, a limited number of studies in which exercise
was self-reported have demonstrated improved heart and adipose measures in the fetus or
neonate with effects that persist into childhood. Previous prenatal exercise intervention
studies using a prescribed exercise regimen have demonstrated the feasibility of such an
approach; however, these studies have focused on maternal health and pregnancy outcomes such
as birth weight. At this point, there is a gap in our understanding as to how carefully
controlled, regular maternal aerobic exercise programs may lead to improvements in
cardiovascular and adiposity risk factors in utero and in neonates.
The central hypothesis of this project is that maternal exercise during pregnancy will
improve the health of the offspring. Specifically, the objectives of the research proposed in
this application are to determine the effects of regular maternal exercise on heart function,
adiposity, and neur0motor function of offspring
The data gathered will be the first documentation, by direct measurement, of the effects of
maternal aerobic exercise on selected heart and obesity outcomes during the prenatal and
postnatal periods. The potential impact of the proposed research on public health education
regarding heart disease and obesity prevention is of public import.
