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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AE Group | Experimental | 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. |
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| RE Group | Experimental | 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. |
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| AERE Group | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Modes | Behavioral | Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise |
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| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure (16wks) | resting SBP | 16 weeks gestation |
| Systolic Blood Pressure (20wks) | resting SBP | 20 weeks gestation |
| Systolic Blood Pressure (24wks) | resting SBP | 24 weeks gestation |
| Systolic Blood Pressure (28wks) | resting SBP | 28 weeks gestation |
| Systolic Blood Pressure (32wks) | resting SBP | 32 weeks gestation |
| Systolic Blood Pressure (36wks) | resting SBP | 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 | during pregnancy |
| Symptom Occurrence | maternal medical record and questionnaire data for occurrence, signs, and symptoms of hypertension/pre-eclampsia | at delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Heart Rate (16wks) | resting heart rate | 16 weeks gestation |
| Maternal Heart Rate (20wks) | resting heart rate | 20 weeks gestation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda E May, MS, PhD | Contact | 2527377072 | mayl@ecu.edu | |
| James DeVente, MD | Contact | deventeja@ecu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Linda E May, MS, PhD | East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Carolina University | Recruiting | Greenville | North Carolina | 27834 | United States |
de-identified data can be shared upon request to researchers
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Pregnant women will be randomized to one of four groups: aerobic exercise, resistance exercise, combination (aerobic + resistance), or control (no exercise). 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, 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.
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| Control | No Intervention | The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle. |
| Placental Efficiency | placental weight gain and birth weight will be used to calculate placental efficiency | at delivery |
| Birth Weight | infant birth weight | 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. | at delivery |
| Maternal Heart Rate (24wks) | resting heart rate | 24 weeks gestation |
| Maternal Heart Rate (28wks) | resting heart rate | 28 weeks gestation |
| Maternal Heart Rate (32wks) | resting heart rate | 32 weeks gestation |
| Maternal Heart Rate (36wks) | resting heart rate | 36 weeks gestation |
| Maternal Blood Pressure (16wks) | resting bp | 16 weeks gestation |
| Maternal Blood Pressure (20wks) | resting bp | 20 weeks gestation |
| Maternal Blood Pressure (24wks) | resting bp | 24 weeks gestation |
| Maternal Blood Pressure (28wks) | resting bp | 28 weeks gestation |
| Maternal Blood Pressure (32wks) | resting bp | 32 weeks gestation |
| Maternal Blood Pressure (36wks) | resting bp | 36 weeks gestation |
| Maternal Body Fat % (16wks) | estimated body fat % | 16 weeks gestation |
| Maternal Body Fat % (20wks) | estimated body fat % | 20 weeks gestation |
| Maternal Body Fat % (24wks) | estimated body fat % | 24 weeks gestation |
| Maternal Body Fat % (28wks) | estimated body fat % | 28 weeks gestation |
| Maternal Body Fat % (32wks) | estimated body fat % | 32 weeks gestation |
| Maternal Body Fat % (36wks) | estimated body fat % | 36 weeks gestation |
| Maternal Circumferences (16wks) | measurements will be assessed using a 3D Scanner and Gulick measuring tape | 16 weeks gestation |
| Maternal Circumferences (20wks) | measurements will be assessed using a 3D Scanner and Gulick measuring tape | 20 weeks gestation |
| Maternal Circumferences (24wks) | measurements will be assessed using a 3D Scanner and Gulick measuring tape | 24 weeks gestation |
| Maternal Circumferences (28wks) | measurements will be assessed using a 3D Scanner and Gulick measuring tape | 28 weeks gestation |
| Maternal Circumferences (32wks) | measurements will be assessed using a 3D Scanner and Gulick measuring tape | 32 weeks gestation |
| Maternal Circumferences (36wks) | measurements will be assessed using a 3D Scanner and Gulick measuring tape | 36 weeks gestation |
| Gestational Weight Gain | weight at delivery minus pre-pregnancy weight | at delivery |
| Delivery Mode | mode of delivery (i.e. vaginal, C-section, instrumentation) will be taken from EHR | at delivery |
| Maternal Blood Glucose (16wks) | blood glucose measured from venipuncture | 16 weeks gestation |
| Maternal Blood Glucose (20wks) | blood glucose measured from venipuncture | 20 weeks gestation |
| Maternal Blood Glucose (24wks) | blood glucose measured from venipuncture | 24 weeks gestation |
| Maternal Blood Glucose (28wks) | blood glucose measured from venipuncture | 28 weeks gestation |
| Maternal Blood Glucose (32wks) | blood glucose measured from venipuncture | 32 weeks gestation |
| Maternal Blood Glucose (36wks) | blood glucose measured from venipuncture | 36 weeks gestation |
| Maternal Blood Lipids (16wks) | blood lipids measured from venipuncture | 16 weeks gestation |
| Maternal Blood Lipids (20wks) | blood lipids measured from venipuncture | 20 weeks gestation |
| Maternal Blood Lipids (24wks) | blood lipids measured from venipuncture | 24 weeks gestation |
| Maternal Blood Lipids (28wks) | blood lipids measured from venipuncture | 28 weeks gestation |
| Maternal Blood Lipids (32wks) | blood lipids measured from venipuncture | 32 weeks gestation |
| Maternal Blood Lipids (36wks) | blood lipids measured from venipuncture | 36 weeks gestation |
| Maternal Plasma Inflammatory Markers (16wks) | inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP) | 16 weeks gestation |
| Maternal Plasma Inflammatory Markers (20wks) | inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP) | 20 weeks gestation |
| Maternal Plasma Inflammatory Markers (24wks) | inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP) | 24 weeks gestation |
| Maternal Plasma Inflammatory Markers (28wks) | inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP) | 28 weeks gestation |
| Maternal Plasma Inflammatory Markers (32wks) | inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP) | 32 weeks gestation |
| Maternal Plasma Inflammatory Markers (36wks) | inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP) | 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 | 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 | 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 | 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 | 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 | 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 | 36 weeks gestation |
| Cord Blood and Placental Inflammatory Markers | inflammatory markers (i.e., IL-1b, IL-6, IL-8,TNF-a, CRP) | 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 | at delivery |
| Infant Body Morphometric Measures | circumferences and weight/length | at delivery |