Physical Activity to Mitigate PreEclampsia Risk

NCT06319014 | Recruiting

• 1 other identifier: 23-001568
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (53)

• Maternal Heart Rate (16wks)

  16 weeks gestation

• Maternal Heart Rate (20wks)

  20 weeks gestation

• Maternal Heart Rate (24wks)

  24 weeks gestation

• Maternal Heart Rate (28wks)

  28 weeks gestation

• Maternal Heart Rate (32wks)

  32 weeks gestation

Study Arms (4)

AE Group

EXPERIMENTAL

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

RE Group

EXPERIMENTAL

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

AERE Group

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Exercise Modes BEHAVIORAL

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

AE Group; AERE Group; RE Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Linda E May, MS, PhD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda E May, MS, PhD

CONTACT

2527377072; mayl@ecu.edu

James DeVente, MD

CONTACT

deventeja@ecu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: June 24, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)