Recruiting

Physical Activity

Sponsor:

East Carolina University

Code:

NCT06319014

Conditions

Pre-Eclampsia

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Exercise Modes

Study Details

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.

Conditions

Pre-Eclampsia

Study ID

NCT06319014

Start date

Jun 24, 2024

Status verified date

Sep, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

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 Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

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.

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.

no intervention: Control

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

Interventions

Exercise Modes

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

Primary outcome measure

  • Systolic Blood Pressure (16wks) [ Time Frame: 16 weeks gestation ]
  • Systolic Blood Pressure (20wks) [ Time Frame: 20 weeks gestation ]
  • Systolic Blood Pressure (24wks) [ Time Frame: 24 weeks gestation ]
  • Systolic Blood Pressure (28wks) [ Time Frame: 28 weeks gestation ]
  • Systolic Blood Pressure (32wks) [ Time Frame: 32 weeks gestation ]
  • Systolic Blood Pressure (36wks) [ Time Frame: 36 weeks gestation ]
  • Maternal Cardiometabolic Risk (CMR) Score [ Time Frame: during pregnancy ]
  • Symptom Occurrence [ Time Frame: at delivery ]
  • Placental Efficiency [ Time Frame: at delivery ]
  • Birth Weight [ Time Frame: at delivery ]
  • Infant Cardiometabolic Risk (CMR) Score [ Time Frame: at delivery ]

Central Contacts and Locations

Central contacts

Linda E May, MS, PhD

2527377072mayl@ecu.edu

James DeVente, MD

deventeja@ecu.edu

Locations

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Linda E May, MS, PhD

2527377072mayl@ecu.edu

James DeVente, MD

deventeja@ecu.edu

More Information

Sponsor

East Carolina University

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by East Carolina University on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.