Physical Activity to Mitigate PreEclampsia Risk

Part of paid clinical trials in Greenville, North Carolina.

Sponsor
East Carolina University
Study ID
NCT06319014
Status
Recruiting
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Conditions

  • Pre-Eclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Exercise Modes — BEHAVIORAL
    Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise

Study Details

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.

Key Dates

Start date
Jun 24, 2024
Status verified
Jun 2024
Primary completion
Apr 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Systolic Blood Pressure (16wks) [ Time Frame: 16 weeks gestation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
East Carolina UniversityGreenvilleNorth Carolina27834
Linda E May, MS, PhD
[email protected]
252-737-7072
James DeVente, MD
[email protected]

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By research site
East Carolina University· Greenville, NC

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