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RecruitingNCT06319014PAMPERUpdated Sep 11, 2026

Physical Activity to Mitigate PreEclampsia Risk

An interventional study of Exercise Modes in Pre-Eclampsia, sponsored by East Carolina University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by East Carolina University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pre-Eclampsia

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03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 224 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

East Carolina University is the lead sponsor of 84 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pre-existing chronic conditions such as , lupus, etc.; taking medicines that affect fetal development; and/or lack of telephone or email contact information).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
224 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • No intervention
    Control

    The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.

Interventions

  • BehavioralExercise Modes

    Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise

06

What researchers measure

Primary outcomes

  1. Systolic Blood Pressure (16wks)

    resting SBP

    Time frame: 16 weeks gestation

  2. Systolic Blood Pressure (20wks)

    resting SBP

    Time frame: 20 weeks gestation

  3. Systolic Blood Pressure (24wks)

    resting SBP

    Time frame: 24 weeks gestation

  4. Systolic Blood Pressure (28wks)

    resting SBP

    Time frame: 28 weeks gestation

  5. Systolic Blood Pressure (32wks)

    resting SBP

    Time frame: 32 weeks gestation

  6. Systolic Blood Pressure (36wks)

    resting SBP

    Time frame: 36 weeks gestation

  7. 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

    Time frame: during pregnancy

  8. Symptom Occurrence

    maternal medical record and questionnaire data for occurrence, signs, and symptoms of hypertension/pre-eclampsia

    Time frame: at delivery

  9. Placental Efficiency

    placental weight gain and birth weight will be used to calculate placental efficiency

    Time frame: at delivery

  10. Birth Weight

    infant birth weight

    Time frame: at delivery

  11. 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.

    Time frame: at delivery

Secondary outcomes

  1. Maternal Heart Rate (16wks)

    resting heart rate

    Time frame: 16 weeks gestation

  2. Maternal Heart Rate (20wks)

    resting heart rate

    Time frame: 20 weeks gestation

  3. Maternal Heart Rate (24wks)

    resting heart rate

    Time frame: 24 weeks gestation

  4. Maternal Heart Rate (28wks)

    resting heart rate

    Time frame: 28 weeks gestation

  5. Maternal Heart Rate (32wks)

    resting heart rate

    Time frame: 32 weeks gestation

  6. Maternal Heart Rate (36wks)

    resting heart rate

    Time frame: 36 weeks gestation

  7. Maternal Blood Pressure (16wks)

    resting bp

    Time frame: 16 weeks gestation

  8. Maternal Blood Pressure (20wks)

    resting bp

    Time frame: 20 weeks gestation

  9. Maternal Blood Pressure (24wks)

    resting bp

    Time frame: 24 weeks gestation

  10. Maternal Blood Pressure (28wks)

    resting bp

    Time frame: 28 weeks gestation

  11. Maternal Blood Pressure (32wks)

    resting bp

    Time frame: 32 weeks gestation

  12. Maternal Blood Pressure (36wks)

    resting bp

    Time frame: 36 weeks gestation

  13. Maternal Body Fat % (16wks)

    estimated body fat %

    Time frame: 16 weeks gestation

  14. Maternal Body Fat % (20wks)

    estimated body fat %

    Time frame: 20 weeks gestation

  15. Maternal Body Fat % (24wks)

    estimated body fat %

    Time frame: 24 weeks gestation

  16. Maternal Body Fat % (28wks)

    estimated body fat %

    Time frame: 28 weeks gestation

  17. Maternal Body Fat % (32wks)

    estimated body fat %

    Time frame: 32 weeks gestation

  18. Maternal Body Fat % (36wks)

    estimated body fat %

    Time frame: 36 weeks gestation

  19. Maternal Circumferences (16wks)

    measurements will be assessed using a 3D Scanner and Gulick measuring tape

    Time frame: 16 weeks gestation

  20. Maternal Circumferences (20wks)

    measurements will be assessed using a 3D Scanner and Gulick measuring tape

    Time frame: 20 weeks gestation

  21. Maternal Circumferences (24wks)

    measurements will be assessed using a 3D Scanner and Gulick measuring tape

    Time frame: 24 weeks gestation

  22. Maternal Circumferences (28wks)

    measurements will be assessed using a 3D Scanner and Gulick measuring tape

    Time frame: 28 weeks gestation

  23. Maternal Circumferences (32wks)

    measurements will be assessed using a 3D Scanner and Gulick measuring tape

    Time frame: 32 weeks gestation

  24. Maternal Circumferences (36wks)

    measurements will be assessed using a 3D Scanner and Gulick measuring tape

    Time frame: 36 weeks gestation

  25. Gestational Weight Gain

    weight at delivery minus pre-pregnancy weight

    Time frame: at delivery

  26. Delivery Mode

    mode of delivery (i.e. vaginal, C-section, instrumentation) will be taken from EHR

    Time frame: at delivery

  27. Maternal Blood Glucose (16wks)

    blood glucose measured from venipuncture

    Time frame: 16 weeks gestation

  28. Maternal Blood Glucose (20wks)

    blood glucose measured from venipuncture

    Time frame: 20 weeks gestation

  29. Maternal Blood Glucose (24wks)

    blood glucose measured from venipuncture

    Time frame: 24 weeks gestation

  30. Maternal Blood Glucose (28wks)

    blood glucose measured from venipuncture

    Time frame: 28 weeks gestation

  31. Maternal Blood Glucose (32wks)

    blood glucose measured from venipuncture

    Time frame: 32 weeks gestation

  32. Maternal Blood Glucose (36wks)

    blood glucose measured from venipuncture

    Time frame: 36 weeks gestation

  33. Maternal Blood Lipids (16wks)

    blood lipids measured from venipuncture

    Time frame: 16 weeks gestation

  34. Maternal Blood Lipids (20wks)

    blood lipids measured from venipuncture

    Time frame: 20 weeks gestation

  35. Maternal Blood Lipids (24wks)

    blood lipids measured from venipuncture

    Time frame: 24 weeks gestation

  36. Maternal Blood Lipids (28wks)

    blood lipids measured from venipuncture

    Time frame: 28 weeks gestation

  37. Maternal Blood Lipids (32wks)

    blood lipids measured from venipuncture

    Time frame: 32 weeks gestation

  38. Maternal Blood Lipids (36wks)

    blood lipids measured from venipuncture

    Time frame: 36 weeks gestation

  39. Maternal Plasma Inflammatory Markers (16wks)

    inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)

    Time frame: 16 weeks gestation

  40. Maternal Plasma Inflammatory Markers (20wks)

    inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)

    Time frame: 20 weeks gestation

  41. Maternal Plasma Inflammatory Markers (24wks)

    inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)

    Time frame: 24 weeks gestation

  42. Maternal Plasma Inflammatory Markers (28wks)

    inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)

    Time frame: 28 weeks gestation

  43. Maternal Plasma Inflammatory Markers (32wks)

    inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)

    Time frame: 32 weeks gestation

  44. Maternal Plasma Inflammatory Markers (36wks)

    inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)

    Time frame: 36 weeks gestation

  45. -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

    Time frame: 16 weeks gestation

  46. -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

    Time frame: 20 weeks gestation

  47. -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

    Time frame: 24 weeks gestation

  48. -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

    Time frame: 28 weeks gestation

  49. -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

    Time frame: 32 weeks gestation

  50. -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

    Time frame: 36 weeks gestation

  51. Cord Blood and Placental Inflammatory Markers

    inflammatory markers (i.e., IL-1b, IL-6, IL-8,TNF-a, CRP)

    Time frame: at delivery

  52. 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

    Time frame: at delivery

  53. Infant Body Morphometric Measures

    circumferences and weight/length

    Time frame: at delivery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — de-identified data can be shared upon request to researchers

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Dec 2027, 41 months after the start.

Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 41 months is above that.

Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2024
First posted
Mar 19, 2024
StartActual
Jun 24, 2024
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06319014
Lead sponsor
East Carolina University
Responsible party
Linda May (Principal Investigator, East Carolina University) — Principal investigator
First posted
Mar 19, 2024
Start date
Jun 24, 2024
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Sep 11, 2026

Study contacts

Linda E May, MS, PhD
Contact
mayl@ecu.edu
2527377072
James DeVente, MD
Contact
deventeja@ecu.edu
Linda E May, MS, PhD
principal investigator · East Carolina University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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