An interventional study of Exercise Modes in Pre-Eclampsia, sponsored by East Carolina University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by East Carolina University · Not applicable, Interventional, and Prevention
The purpose of this study is to compare the effects of aerobic (AE), resistance (RE), and combination (AERE) exercise throughout pregnancy on selected maternal and fetal/neonatal physiological variables in women at-risk for preeclampsia. The central hypothesis of this project is that exercise will decrease severity and occurrence of preeclampsia symptoms, thus improving maternal, pregnancy, and birth outcomes.
Aim 1. Determine the influence of different exercise modes during pregnancy at risk of preeclampsia on maternal cardiometabolic health.
Aim 2. Determine the most effective exercise mode in pregnancy at risk of preeclampsia on improving birth and infant health outcomes.
Approximately 5% of pregnancies worldwide and in the United States were complicated by preeclampsia. Women who develop Preeclampsia in Pregnancy go on to develop Cardiovascular issues (Catov and other studies). Further, infants from preeclamptic pregnancies are at increased risk of mortality and co-morbid conditions (hypertension, excessive weight gain, increased BMI). However, preliminary data suggests that exercise will attenuate or prevent the severity and risk of preeclampsia; thus improving health for women and children. The purpose of this study is to compare the effects of aerobic (AE), resistance (RE), and combination (AERE) exercise throughout pregnancy on selected maternal and fetal/neonatal physiological variables in women at-risk for preeclampsia. The investigators hypothesize that following changes will occur:(1) improvements in the measurements of maternal resting heart rate, blood pressure, cardiometabolic risk (CMR) score, placental growth factor (PlGF), preeclampsia severity, onset of preeclampsia of symptoms at each time point (once per visit); and (2) improvements in birth and infant measurements of decreased C-sections, preterm deliveries, hospital stay, birth weight, placental efficiency at birth when exposed to different modes of maternal exercise compared no exercise (usual care) with greatest differences in AERE trained group. Ultimately, our goal is to determine which exercise program is most effective at attenuating or preventing preeclampsia and thus improving health outcomes for mother and child.
Exclusion Criteria:
The AE group will exercise on aerobic machines (i.e. treadmill, elliptical, bicycle) All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.
Behavioral: Exercise Modes
The RE group will perform 12-15 repetitions of 10-12 resistance exercises in a circuit, for 3 sets, with a rest period of 30-60 seconds between sets as needed.\[172\] Seated isokinetic exercise using resistance machines will target all major muscle groups. Light dumbbells and resistance bands will be used if the participant is unable to lift the minimal load on machines. Core exercises will be performed at the end of the session (i.e. seated side bends) All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.
Behavioral: Exercise Modes
AERE group will alternate between AE exercise and RE; for this group, RE exercises will consist of 1 set of 12-15 repetitions of 4 resistance exercises, then 5 minutes of AE, then repeat this cycle with different exercises. All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.
Behavioral: Exercise Modes
The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.
Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise
Systolic Blood Pressure (16wks)
resting SBP
Time frame: 16 weeks gestation
Systolic Blood Pressure (20wks)
resting SBP
Time frame: 20 weeks gestation
Systolic Blood Pressure (24wks)
resting SBP
Time frame: 24 weeks gestation
Systolic Blood Pressure (28wks)
resting SBP
Time frame: 28 weeks gestation
Systolic Blood Pressure (32wks)
resting SBP
Time frame: 32 weeks gestation
Systolic Blood Pressure (36wks)
resting SBP
Time frame: 36 weeks gestation
Maternal Cardiometabolic Risk (CMR) Score
summation of age- and sexstandardized z-scores for waist circumference (or BMI), triglycerides, systolic blood pressure (SBP), glucose (insulin or HOMA-IR), and inverse HDL, with a lower CMR score indicating lower risk
Time frame: during pregnancy
Symptom Occurrence
maternal medical record and questionnaire data for occurrence, signs, and symptoms of hypertension/pre-eclampsia
Time frame: at delivery
Placental Efficiency
placental weight gain and birth weight will be used to calculate placental efficiency
Time frame: at delivery
Birth Weight
infant birth weight
Time frame: at delivery
Infant Cardiometabolic Risk (CMR) Score
The CMR score will be a summation of age- and sex-standardized z-scores for abdominal circumference (or BMI),systolic blood pressure (SBP), glucose, and inverse HDL, with a lower CMR score indicating lower risk.
Time frame: at delivery
Maternal Heart Rate (16wks)
resting heart rate
Time frame: 16 weeks gestation
Maternal Heart Rate (20wks)
resting heart rate
Time frame: 20 weeks gestation
Maternal Heart Rate (24wks)
resting heart rate
Time frame: 24 weeks gestation
Maternal Heart Rate (28wks)
resting heart rate
Time frame: 28 weeks gestation
Maternal Heart Rate (32wks)
resting heart rate
Time frame: 32 weeks gestation
Maternal Heart Rate (36wks)
resting heart rate
Time frame: 36 weeks gestation
Maternal Blood Pressure (16wks)
resting bp
Time frame: 16 weeks gestation
Maternal Blood Pressure (20wks)
resting bp
Time frame: 20 weeks gestation
Maternal Blood Pressure (24wks)
resting bp
Time frame: 24 weeks gestation
Maternal Blood Pressure (28wks)
resting bp
Time frame: 28 weeks gestation
Maternal Blood Pressure (32wks)
resting bp
Time frame: 32 weeks gestation
Maternal Blood Pressure (36wks)
resting bp
Time frame: 36 weeks gestation
Maternal Body Fat % (16wks)
estimated body fat %
Time frame: 16 weeks gestation
Maternal Body Fat % (20wks)
estimated body fat %
Time frame: 20 weeks gestation
Maternal Body Fat % (24wks)
estimated body fat %
Time frame: 24 weeks gestation
Maternal Body Fat % (28wks)
estimated body fat %
Time frame: 28 weeks gestation
Maternal Body Fat % (32wks)
estimated body fat %
Time frame: 32 weeks gestation
Maternal Body Fat % (36wks)
estimated body fat %
Time frame: 36 weeks gestation
Maternal Circumferences (16wks)
measurements will be assessed using a 3D Scanner and Gulick measuring tape
Time frame: 16 weeks gestation
Maternal Circumferences (20wks)
measurements will be assessed using a 3D Scanner and Gulick measuring tape
Time frame: 20 weeks gestation
Maternal Circumferences (24wks)
measurements will be assessed using a 3D Scanner and Gulick measuring tape
Time frame: 24 weeks gestation
Maternal Circumferences (28wks)
measurements will be assessed using a 3D Scanner and Gulick measuring tape
Time frame: 28 weeks gestation
Maternal Circumferences (32wks)
measurements will be assessed using a 3D Scanner and Gulick measuring tape
Time frame: 32 weeks gestation
Maternal Circumferences (36wks)
measurements will be assessed using a 3D Scanner and Gulick measuring tape
Time frame: 36 weeks gestation
Gestational Weight Gain
weight at delivery minus pre-pregnancy weight
Time frame: at delivery
Delivery Mode
mode of delivery (i.e. vaginal, C-section, instrumentation) will be taken from EHR
Time frame: at delivery
Maternal Blood Glucose (16wks)
blood glucose measured from venipuncture
Time frame: 16 weeks gestation
Maternal Blood Glucose (20wks)
blood glucose measured from venipuncture
Time frame: 20 weeks gestation
Maternal Blood Glucose (24wks)
blood glucose measured from venipuncture
Time frame: 24 weeks gestation
Maternal Blood Glucose (28wks)
blood glucose measured from venipuncture
Time frame: 28 weeks gestation
Maternal Blood Glucose (32wks)
blood glucose measured from venipuncture
Time frame: 32 weeks gestation
Maternal Blood Glucose (36wks)
blood glucose measured from venipuncture
Time frame: 36 weeks gestation
Maternal Blood Lipids (16wks)
blood lipids measured from venipuncture
Time frame: 16 weeks gestation
Maternal Blood Lipids (20wks)
blood lipids measured from venipuncture
Time frame: 20 weeks gestation
Maternal Blood Lipids (24wks)
blood lipids measured from venipuncture
Time frame: 24 weeks gestation
Maternal Blood Lipids (28wks)
blood lipids measured from venipuncture
Time frame: 28 weeks gestation
Maternal Blood Lipids (32wks)
blood lipids measured from venipuncture
Time frame: 32 weeks gestation
Maternal Blood Lipids (36wks)
blood lipids measured from venipuncture
Time frame: 36 weeks gestation
Maternal Plasma Inflammatory Markers (16wks)
inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)
Time frame: 16 weeks gestation
Maternal Plasma Inflammatory Markers (20wks)
inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)
Time frame: 20 weeks gestation
Maternal Plasma Inflammatory Markers (24wks)
inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)
Time frame: 24 weeks gestation
Maternal Plasma Inflammatory Markers (28wks)
inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)
Time frame: 28 weeks gestation
Maternal Plasma Inflammatory Markers (32wks)
inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)
Time frame: 32 weeks gestation
Maternal Plasma Inflammatory Markers (36wks)
inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)
Time frame: 36 weeks gestation
-omics Metabolites (16wks)
MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses
Time frame: 16 weeks gestation
-omics Metabolites (20wks)
MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses
Time frame: 20 weeks gestation
-omics Metabolites (24wks)
MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses
Time frame: 24 weeks gestation
-omics Metabolites (28wks)
MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses
Time frame: 28 weeks gestation
-omics Metabolites (32wks)
MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses
Time frame: 32 weeks gestation
-omics Metabolites (36wks)
MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses
Time frame: 36 weeks gestation
Cord Blood and Placental Inflammatory Markers
inflammatory markers (i.e., IL-1b, IL-6, IL-8,TNF-a, CRP)
Time frame: at delivery
Cord Blood and Placental -omics Metabolites
MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses
Time frame: at delivery
Infant Body Morphometric Measures
circumferences and weight/length
Time frame: at delivery
Plan to share: No — de-identified data can be shared upon request to researchers
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