Physical Activity to Mitigate PreEclampsia Risk
ConditionPre-Eclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorEast Carolina University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
healthy women, age 18-40 years, <16 weeks' gestation, with singleton pregnancy; women (BMI:18.5-45.0), sedentary, cleared by their obstetric provider.
Disqualifiers
pre-existing chronic conditions such as HIV, lupus, etc.; taking medicines that affect fetal development; and/or lack of telephone or email contact information).
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Modes
BehavioralModerate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise
Treatment groups
224 Participants
are divided into 4 treatment groupsGroup A: AE GroupExperimental treatment 1 intervention
Group B: RE GroupExperimental treatment 1 intervention
Group C: AERE GroupExperimental treatment 1 intervention
Group D: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Systolic Blood Pressure (16wks)
resting SBP
Time frame
16 weeks gestation2
Systolic Blood Pressure (20wks)
resting SBP
Time frame
20 weeks gestation3
Systolic Blood Pressure (24wks)
resting SBP
Time frame
24 weeks gestation4
Systolic Blood Pressure (28wks)
resting SBP
Time frame
28 weeks gestationSecondary outcomes
1
Maternal Heart Rate (16wks)
resting heart rate
Time frame
16 weeks gestation2
Maternal Heart Rate (20wks)
resting heart rate
Time frame
20 weeks gestation3
Maternal Heart Rate (24wks)
resting heart rate
Time frame
24 weeks gestation4
Maternal Heart Rate (28wks)
resting heart rate
Time frame
28 weeks gestationSponsors and contacts
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Source ClinicalTrials.gov