Clinical trial NCT06319014: Physical Activity to Mitigate PreEclampsia Risk
Official title: Physical Activity to Mitigate PreEclampsia Risk (PAMPER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-Eclampsia
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* healthy women, age 18-40 years, \<16 weeks' gestation, with singleton pregnancy; women (BMI:18.5-45.0), sedentary, cleared by their obstetric provider.

Exclusion Criteria:

* pre-existing chronic conditions such as HIV, lupus, etc.; taking medicines that affect fetal development; and/or lack of telephone or email contact information).

Primary outcomes:
measure: Systolic Blood Pressure (16wks)
timeFrame: 16 weeks gestation
measure: Systolic Blood Pressure (20wks)
timeFrame: 20 weeks gestation
measure: Systolic Blood Pressure (24wks)
timeFrame: 24 weeks gestation
measure: Systolic Blood Pressure (28wks)
timeFrame: 28 weeks gestation
measure: Systolic Blood Pressure (32wks)
timeFrame: 32 weeks gestation
measure: Systolic Blood Pressure (36wks)
timeFrame: 36 weeks gestation
measure: Maternal Cardiometabolic Risk (CMR) Score
timeFrame: during pregnancy
measure: Symptom Occurrence
timeFrame: at delivery
measure: Placental Efficiency
timeFrame: at delivery
measure: Birth Weight
timeFrame: at delivery
measure: Infant Cardiometabolic Risk (CMR) Score
timeFrame: at delivery
Secondary outcomes:
measure: Maternal Heart Rate (16wks)
timeFrame: 16 weeks gestation
measure: Maternal Heart Rate (20wks)
timeFrame: 20 weeks gestation
measure: Maternal Heart Rate (24wks)
timeFrame: 24 weeks gestation
measure: Maternal Heart Rate (28wks)
timeFrame: 28 weeks gestation
measure: Maternal Heart Rate (32wks)
timeFrame: 32 weeks gestation
measure: Maternal Heart Rate (36wks)
timeFrame: 36 weeks gestation
measure: Maternal Blood Pressure (16wks)
timeFrame: 16 weeks gestation
measure: Maternal Blood Pressure (20wks)
timeFrame: 20 weeks gestation
measure: Maternal Blood Pressure (24wks)
timeFrame: 24 weeks gestation
measure: Maternal Blood Pressure (28wks)
timeFrame: 28 weeks gestation
measure: Maternal Blood Pressure (32wks)
timeFrame: 32 weeks gestation
measure: Maternal Blood Pressure (36wks)
timeFrame: 36 weeks gestation
measure: Maternal Body Fat % (16wks)
timeFrame: 16 weeks gestation
measure: Maternal Body Fat % (20wks)
timeFrame: 20 weeks gestation
measure: Maternal Body Fat % (24wks)
timeFrame: 24 weeks gestation
measure: Maternal Body Fat % (28wks)
timeFrame: 28 weeks gestation
measure: Maternal Body Fat % (32wks)
timeFrame: 32 weeks gestation
measure: Maternal Body Fat % (36wks)
timeFrame: 36 weeks gestation
measure: Maternal Circumferences (16wks)
timeFrame: 16 weeks gestation
measure: Maternal Circumferences (20wks)
timeFrame: 20 weeks gestation
measure: Maternal Circumferences (24wks)
timeFrame: 24 weeks gestation
measure: Maternal Circumferences (28wks)
timeFrame: 28 weeks gestation
measure: Maternal Circumferences (32wks)
timeFrame: 32 weeks gestation
measure: Maternal Circumferences (36wks)
timeFrame: 36 weeks gestation
measure: Gestational Weight Gain
timeFrame: at delivery
measure: Delivery Mode
timeFrame: at delivery
measure: Maternal Blood Glucose (16wks)
timeFrame: 16 weeks gestation
measure: Maternal Blood Glucose (20wks)
timeFrame: 20 weeks gestation
measure: Maternal Blood Glucose (24wks)
timeFrame: 24 weeks gestation
measure: Maternal Blood Glucose (28wks)
timeFrame: 28 weeks gestation
measure: Maternal Blood Glucose (32wks)
timeFrame: 32 weeks gestation
measure: Maternal Blood Glucose (36wks)
timeFrame: 36 weeks gestation
measure: Maternal Blood Lipids (16wks)
timeFrame: 16 weeks gestation
measure: Maternal Blood Lipids (20wks)
timeFrame: 20 weeks gestation
measure: Maternal Blood Lipids (24wks)
timeFrame: 24 weeks gestation
measure: Maternal Blood Lipids (28wks)
timeFrame: 28 weeks gestation
measure: Maternal Blood Lipids (32wks)
timeFrame: 32 weeks gestation
measure: Maternal Blood Lipids (36wks)
timeFrame: 36 weeks gestation
measure: Maternal Plasma Inflammatory Markers (16wks)
timeFrame: 16 weeks gestation
measure: Maternal Plasma Inflammatory Markers (20wks)
timeFrame: 20 weeks gestation
measure: Maternal Plasma Inflammatory Markers (24wks)
timeFrame: 24 weeks gestation
measure: Maternal Plasma Inflammatory Markers (28wks)
timeFrame: 28 weeks gestation
measure: Maternal Plasma Inflammatory Markers (32wks)
timeFrame: 32 weeks gestation
measure: Maternal Plasma Inflammatory Markers (36wks)
timeFrame: 36 weeks gestation
measure: -omics Metabolites (16wks)
timeFrame: 16 weeks gestation
measure: -omics Metabolites (20wks)
timeFrame: 20 weeks gestation
measure: -omics Metabolites (24wks)
timeFrame: 24 weeks gestation
measure: -omics Metabolites (28wks)
timeFrame: 28 weeks gestation
measure: -omics Metabolites (32wks)
timeFrame: 32 weeks gestation
measure: -omics Metabolites (36wks)
timeFrame: 36 weeks gestation
measure: Cord Blood and Placental Inflammatory Markers
timeFrame: at delivery
measure: Cord Blood and Placental -omics Metabolites
timeFrame: at delivery
measure: Infant Body Morphometric Measures
timeFrame: at delivery
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Linda E May, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: