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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ during pregnancy

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met