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Behavioural Intervention

Exercise for Preeclampsia (PAMPER Trial)

N/A
Recruiting
Led By Linda E May, MS, PhD
Research Sponsored by East Carolina University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* healthy women, age 18-40 years, \<16 weeks' gestation, with singleton pregnancy; women (BMI:18.5-45.0), sedentary, cleared by their obstetric provider.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at delivery
Awards & highlights

Summary

This trial aims to study the effects of different types of exercise (aerobic, resistance, and combination) during pregnancy on women at risk for preeclampsia. The hypothesis is that exercise

Who is the study for?
This trial is for healthy women aged 18-40, less than 16 weeks pregnant with one baby. Participants should have a BMI between 18.5 and 45.0, lead a sedentary lifestyle, and must be cleared by their obstetric provider to join.
What is being tested?
The study compares the effects of different types of exercise on women at risk for preeclampsia: aerobic (AE), resistance (RE), and a combination of both (AERE). It aims to see which exercise mode best reduces symptoms and improves health outcomes for mother and baby.
What are the potential side effects?
While not explicitly stated, potential side effects may include typical exercise-related risks such as muscle strain or injury. However, these exercises are designed to be safe during pregnancy when performed correctly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during pregnancy
This trial's timeline: 3 weeks for screening, Varies for treatment, and during pregnancy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Birth Weight
Infant Cardiometabolic Risk (CMR) Score
Maternal Cardiometabolic Risk (CMR) Score
+8 more
Secondary study objectives
-omics Metabolites (16wks)
-omics Metabolites (20wks)
-omics Metabolites (24wks)
+50 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: RE GroupExperimental Treatment1 Intervention
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.
Group II: AERE GroupExperimental Treatment1 Intervention
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.
Group III: AE GroupExperimental Treatment1 Intervention
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.
Group IV: ControlActive Control1 Intervention
The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.

Find a Location

Who is running the clinical trial?

East Carolina UniversityLead Sponsor
108 Previous Clinical Trials
38,691 Total Patients Enrolled
Linda E May, MS, PhDPrincipal InvestigatorEast Carolina University
1 Previous Clinical Trials
133 Total Patients Enrolled
~149 spots leftby Apr 2026
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