protocolSection identificationModule nctId: NCT06319014, orgStudyIdInfo id: 23-001568, briefTitle: Physical Activity to Mitigate PreEclampsia Risk, acronym: PAMPER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: East Carolina University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Pre-Eclampsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 224, type: ESTIMATED, armsInterventionsModule interventions name: Exercise Modes, outcomesModule primaryOutcomes measure: Systolic Blood Pressure (16wks), primaryOutcomes measure: Systolic Blood Pressure (20wks), primaryOutcomes measure: Systolic Blood Pressure (24wks), primaryOutcomes measure: Systolic Blood Pressure (28wks), primaryOutcomes measure: Systolic Blood Pressure (32wks), primaryOutcomes measure: Systolic Blood Pressure (36wks), primaryOutcomes measure: Maternal Cardiometabolic Risk (CMR) Score, primaryOutcomes measure: Symptom Occurrence, primaryOutcomes measure: Placental Efficiency, primaryOutcomes measure: Birth Weight, primaryOutcomes measure: Infant Cardiometabolic Risk (CMR) Score, secondaryOutcomes measure: Maternal Heart Rate (16wks), secondaryOutcomes measure: Maternal Heart Rate (20wks), secondaryOutcomes measure: Maternal Heart Rate (24wks), secondaryOutcomes measure: Maternal Heart Rate (28wks), secondaryOutcomes measure: Maternal Heart Rate (32wks), secondaryOutcomes measure: Maternal Heart Rate (36wks), secondaryOutcomes measure: Maternal Blood Pressure (16wks), secondaryOutcomes measure: Maternal Blood Pressure (20wks), secondaryOutcomes measure: Maternal Blood Pressure (24wks), secondaryOutcomes measure: Maternal Blood Pressure (28wks), secondaryOutcomes measure: Maternal Blood Pressure (32wks), secondaryOutcomes measure: Maternal Blood Pressure (36wks), secondaryOutcomes measure: Maternal Body Fat % (16wks), secondaryOutcomes measure: Maternal Body Fat % (20wks), secondaryOutcomes measure: Maternal Body Fat % (24wks), secondaryOutcomes measure: Maternal Body Fat % (28wks), secondaryOutcomes measure: Maternal Body Fat % (32wks), secondaryOutcomes measure: Maternal Body Fat % (36wks), secondaryOutcomes measure: Maternal Circumferences (16wks), secondaryOutcomes measure: Maternal Circumferences (20wks), secondaryOutcomes measure: Maternal Circumferences (24wks), secondaryOutcomes measure: Maternal Circumferences (28wks), secondaryOutcomes measure: Maternal Circumferences (32wks), secondaryOutcomes measure: Maternal Circumferences (36wks), secondaryOutcomes measure: Gestational Weight Gain, secondaryOutcomes measure: Delivery Mode, secondaryOutcomes measure: Maternal Blood Glucose (16wks), secondaryOutcomes measure: Maternal Blood Glucose (20wks), secondaryOutcomes measure: Maternal Blood Glucose (24wks), secondaryOutcomes measure: Maternal Blood Glucose (28wks), secondaryOutcomes measure: Maternal Blood Glucose (32wks), secondaryOutcomes measure: Maternal Blood Glucose (36wks), secondaryOutcomes measure: Maternal Blood Lipids (16wks), secondaryOutcomes measure: Maternal Blood Lipids (20wks), secondaryOutcomes measure: Maternal Blood Lipids (24wks), secondaryOutcomes measure: Maternal Blood Lipids (28wks), secondaryOutcomes measure: Maternal Blood Lipids (32wks), secondaryOutcomes measure: Maternal Blood Lipids (36wks), secondaryOutcomes measure: Maternal Plasma Inflammatory Markers (16wks), secondaryOutcomes measure: Maternal Plasma Inflammatory Markers (20wks), secondaryOutcomes measure: Maternal Plasma Inflammatory Markers (24wks), secondaryOutcomes measure: Maternal Plasma Inflammatory Markers (28wks), secondaryOutcomes measure: Maternal Plasma Inflammatory Markers (32wks), secondaryOutcomes measure: Maternal Plasma Inflammatory Markers (36wks), secondaryOutcomes measure: -omics Metabolites (16wks), secondaryOutcomes measure: -omics Metabolites (20wks), secondaryOutcomes measure: -omics Metabolites (24wks), secondaryOutcomes measure: -omics Metabolites (28wks), secondaryOutcomes measure: -omics Metabolites (32wks), secondaryOutcomes measure: -omics Metabolites (36wks), secondaryOutcomes measure: Cord Blood and Placental Inflammatory Markers, secondaryOutcomes measure: Cord Blood and Placental -omics Metabolites, secondaryOutcomes measure: Infant Body Morphometric Measures, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False