Physical Activity to Mitigate PreEclampsia Risk (PAMPER)

Physical Activity to Mitigate PreEclampsia Risk (PAMPER)

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.

Study Overview

• Status: Recruiting
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Behavioral: Exercise Modes

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.

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda E May, MS, PhD; Phone Number: 2527377072; Email: mayl@ecu.edu
• Study Contact Backup: Name: James DeVente, MD; Email: deventeja@ecu.edu

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Recruiting
      • East Carolina University
      • Contact: Linda E May, MS, PhD; Phone Number: 252-737-7072; Email: mayl@ecu.edu
      • Contact: James DeVente, MD; Email: deventeja@ecu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AE Group; 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; Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise
Experimental: RE Group; 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; Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise
Experimental: AERE Group; 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; Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise
No Intervention: Control; The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Heart Rate (16wks)	resting heart rate	16 weeks gestation
Maternal Heart Rate (20wks)	resting heart rate	20 weeks gestation
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

Collaborators and Investigators

• Sponsor: East Carolina University
• Investigators: Principal Investigator: Linda E May, MS, PhD, East Carolina University

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 23-001568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: de-identified data can be shared upon request to researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No