Physical Activity to Mitigate PreEclampsia Risk
- Conditions
- Pre-Eclampsia
- Interventions
- Behavioral: Exercise Modes
- Registration Number
- NCT06319014
- Lead Sponsor
- East Carolina University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 224
- healthy women, age 18-40 years, <16 weeks' gestation, with singleton pregnancy; women (BMI:18.5-45.0), sedentary, cleared by their obstetric provider.
- pre-existing chronic conditions such as HIV, lupus, etc.; taking medicines that affect fetal development; and/or lack of telephone or email contact information).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RE Group 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. AERE Group 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. AE Group Exercise Modes 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.
- Primary Outcome Measures
Name Time Method Systolic Blood Pressure (16wks) 16 weeks gestation resting SBP
Systolic Blood Pressure (24wks) 24 weeks gestation resting SBP
Maternal Cardiometabolic Risk (CMR) Score during pregnancy 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
Systolic Blood Pressure (28wks) 28 weeks gestation resting SBP
Symptom Occurrence at delivery maternal medical record and questionnaire data for occurrence, signs, and symptoms of hypertension/pre-eclampsia
Systolic Blood Pressure (20wks) 20 weeks gestation resting SBP
Birth Weight at delivery infant birth weight
Infant Cardiometabolic Risk (CMR) Score at delivery 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.
Placental Efficiency at delivery placental weight gain and birth weight will be used to calculate placental efficiency
Systolic Blood Pressure (32wks) 32 weeks gestation resting SBP
Systolic Blood Pressure (36wks) 36 weeks gestation resting SBP
- Secondary Outcome Measures
Name Time Method Maternal Heart Rate (24wks) 24 weeks gestation resting heart rate
Maternal Heart Rate (32wks) 32 weeks gestation resting heart rate
Maternal Body Fat % (24wks) 24 weeks gestation estimated body fat %
Maternal Body Fat % (28wks) 28 weeks gestation estimated body fat %
Maternal Body Fat % (32wks) 32 weeks gestation estimated body fat %
Maternal Body Fat % (36wks) 36 weeks gestation estimated body fat %
Maternal Heart Rate (28wks) 28 weeks gestation resting heart rate
Maternal Blood Pressure (24wks) 24 weeks gestation resting bp
Maternal Heart Rate (36wks) 36 weeks gestation resting heart rate
Maternal Blood Pressure (16wks) 16 weeks gestation resting bp
Maternal Blood Pressure (20wks) 20 weeks gestation resting bp
Maternal Blood Pressure (32wks) 32 weeks gestation resting bp
Maternal Heart Rate (16wks) 16 weeks gestation resting heart rate
Maternal Heart Rate (20wks) 20 weeks gestation resting heart rate
Maternal Blood Pressure (28wks) 28 weeks gestation resting bp
Maternal Blood Pressure (36wks) 36 weeks gestation resting bp
Maternal Body Fat % (16wks) 16 weeks gestation estimated body fat %
Maternal Body Fat % (20wks) 20 weeks gestation estimated body fat %
Maternal Circumferences (20wks) 20 weeks gestation measurements will be assessed using a 3D Scanner and Gulick measuring tape
Maternal Blood Glucose (28wks) 28 weeks gestation blood glucose measured from venipuncture
Maternal Blood Glucose (32wks) 32 weeks gestation blood glucose measured from venipuncture
Maternal Circumferences (24wks) 24 weeks gestation measurements will be assessed using a 3D Scanner and Gulick measuring tape
Delivery Mode at delivery mode of delivery (i.e. vaginal, C-section, instrumentation) will be taken from EHR
Maternal Blood Glucose (20wks) 20 weeks gestation blood glucose measured from venipuncture
Maternal Blood Glucose (36wks) 36 weeks gestation blood glucose measured from venipuncture
Maternal Blood Lipids (20wks) 20 weeks gestation blood lipids measured from venipuncture
Maternal Blood Lipids (28wks) 28 weeks gestation blood lipids measured from venipuncture
Maternal Plasma Inflammatory Markers (16wks) 16 weeks gestation inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)
Maternal Plasma Inflammatory Markers (32wks) 32 weeks gestation inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)
-omics Metabolites (16wks) 16 weeks gestation 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
Maternal Circumferences (36wks) 36 weeks gestation measurements will be assessed using a 3D Scanner and Gulick measuring tape
Maternal Blood Glucose (16wks) 16 weeks gestation blood glucose measured from venipuncture
Maternal Blood Lipids (36wks) 36 weeks gestation blood lipids measured from venipuncture
Maternal Plasma Inflammatory Markers (24wks) 24 weeks gestation inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)
-omics Metabolites (24wks) 24 weeks gestation 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
-omics Metabolites (28wks) 28 weeks gestation 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
-omics Metabolites (36wks) 36 weeks gestation 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
Cord Blood and Placental -omics Metabolites at delivery 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
Maternal Circumferences (16wks) 16 weeks gestation measurements will be assessed using a 3D Scanner and Gulick measuring tape
Maternal Circumferences (28wks) 28 weeks gestation measurements will be assessed using a 3D Scanner and Gulick measuring tape
Maternal Circumferences (32wks) 32 weeks gestation measurements will be assessed using a 3D Scanner and Gulick measuring tape
Gestational Weight Gain at delivery weight at delivery minus pre-pregnancy weight
Maternal Blood Glucose (24wks) 24 weeks gestation blood glucose measured from venipuncture
Maternal Blood Lipids (16wks) 16 weeks gestation blood lipids measured from venipuncture
Maternal Plasma Inflammatory Markers (36wks) 36 weeks gestation inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)
Maternal Blood Lipids (32wks) 32 weeks gestation blood lipids measured from venipuncture
Maternal Plasma Inflammatory Markers (28wks) 28 weeks gestation inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)
Maternal Blood Lipids (24wks) 24 weeks gestation blood lipids measured from venipuncture
Maternal Plasma Inflammatory Markers (20wks) 20 weeks gestation inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)
-omics Metabolites (20wks) 20 weeks gestation 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
-omics Metabolites (32wks) 32 weeks gestation 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
Cord Blood and Placental Inflammatory Markers at delivery inflammatory markers (i.e., IL-1b, IL-6, IL-8,TNF-a, CRP)
Infant Body Morphometric Measures at delivery circumferences and weight/length
Trial Locations
- Locations (1)
East Carolina University
🇺🇸Greenville, North Carolina, United States