Exercise for Preeclampsia

(PAMPER Trial)

Overseen By Linda E May, MS, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: East Carolina University

Must not be taking: Fetal development drugs

Disqualifiers: HIV, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

224 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how different types of exercise during pregnancy can reduce the severity and occurrence of preeclampsia, a condition marked by high blood pressure that can lead to serious complications for both mother and baby. Participants will be divided into groups to try aerobic exercise, resistance training, or a combination of both, with some participants serving as a control group. The goal is to determine which exercise routine best improves health outcomes for both the mother and the infant. The trial seeks healthy, sedentary women who are less than 16 weeks pregnant with a single baby.

As an unphased trial, this study offers participants the chance to contribute to important research that could enhance pregnancy health for many women.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those taking medicines that affect fetal development.

Is there any evidence suggesting that this trial's exercise modes are likely to be safe?

Research shows that exercising during pregnancy is usually safe and beneficial. Studies indicate that women who stay active while pregnant have a lower risk of developing preeclampsia, a condition characterized by high blood pressure. Aerobic exercise, like walking or swimming, is generally safe for most pregnancies, especially at a moderate pace. This type of exercise can help prevent preeclampsia and its complications.

Resistance exercises, such as lifting light weights, also appear safe and may reduce the risk of preeclampsia. Combining aerobic and resistance exercises is considered safe for most pregnancies without complications and can improve heart health.

Overall, exercise during pregnancy carries few risks and offers benefits to most women. This aligns with advice from health organizations that recommend regular moderate exercise during pregnancy. Always consult a healthcare provider before starting any new exercise routine while pregnant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise treatments for preeclampsia because they offer a non-pharmacological approach that could complement or even reduce the need for medication. Unlike traditional treatments that often focus on medication to manage symptoms, these exercise protocols aim to improve cardiovascular and muscular health, potentially mitigating the effects of preeclampsia. The unique aspect is the variety of exercise modes being tested: aerobic exercise, resistance exercise, and a combination of both, which could provide tailored options for expecting mothers based on their needs and capabilities. By following well-established guidelines from reputable health organizations, these exercise routines are designed to be safe and beneficial, offering a holistic way to manage preeclampsia.

What evidence suggests that this trial's exercise modes could be effective for preeclampsia?

This trial will compare different exercise regimens to assess their impact on reducing the risk of preeclampsia during pregnancy. Research has shown that regular exercise during pregnancy can lower the risk of preeclampsia, a condition characterized by high blood pressure. Participants may join the AE Group, which focuses on aerobic exercises like walking or cycling, beneficial for heart health. Alternatively, they might join the RE Group, performing resistance exercises involving weight lifting, which can also reduce the risk of preeclampsia. The AERE Group will alternate between aerobic and resistance exercises, potentially offering the best protection by combining both types. ^{1 6 7 8 9}

Who Is on the Research Team?

Linda E May, MS, PhD

Principal Investigator

East Carolina University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a healthy pregnant woman, aged 18-40, less than 16 weeks along, with a normal pregnancy, and have been cleared by my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in aerobic, resistance, or combination exercise throughout pregnancy to assess effects on maternal and fetal/neonatal physiological variables.

36 weeks

Weekly exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on birth outcomes and infant health.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Modes

Trial Overview 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.

How Is the Trial Designed?

Group I: RE Group Experimental Treatment 1 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 Group Experimental Treatment 1 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 Group Experimental Treatment 1 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: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

East Carolina University

Lead Sponsor

Trials

111

Recruited

42,400+

Published Research Related to This Trial

A systematic review of 17 studies found that physical activity has a protective effect against the development of pre-eclampsia, with a significant odds ratio of 0.77, indicating a reduced risk for those who exercise.

While case-control studies showed a clear benefit, prospective cohort studies did not find a significant difference, suggesting that more research is needed to fully understand the relationship between physical activity and pre-eclampsia prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and physical activity in the prevention of pre-eclampsia: systematic review. Kasawara, KT., do Nascimento, SL., Costa, ML., et al.[2018]

The study investigates the effects of a walking intervention compared to stretching exercises on sedentary pregnant women at risk for preeclampsia, focusing on safety and efficacy from 18 weeks gestation until birth.

The walking intervention involves moderate-intensity exercise, which is designed to monitor safety closely and aims to reduce the incidence of preeclampsia, while also assessing physiological effects and birth outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized comparative trial of the efficacy and safety of exercise during pregnancy: design and methods. Yeo, S.[2006]

In a study of 3,679 nulliparous women in Amsterdam, physical activity during leisure time early in pregnancy was not linked to a reduced risk of preeclampsia or gestational hypertension, with incidences of 3.5% and 4.4% respectively.

The findings suggest that engaging in leisure-time physical activity does not impact the likelihood of developing these pregnancy-related conditions, indicating that other factors may play a more significant role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does physical activity in leisure time early in pregnancy reduce the incidence of preeclampsia or gestational hypertension? Vollebregt, KC., Wolf, H., Boer, K., et al.[2010]

In a randomized controlled trial involving 116 pregnant women with chronic hypertension and/or previous preeclampsia, supervised physical exercise on a stationary bicycle once a week did not negatively impact maternal or neonatal outcomes.

The study found no significant differences in delivery methods, maternal morbidity, or neonatal health indicators between the exercise group and the control group, suggesting that this form of exercise is safe for these high-risk pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal and Perinatal Outcomes of Exercise in Pregnant Women with Chronic Hypertension and/or Previous Preeclampsia: A Randomized Controlled Trial. Kasawara, KT., Burgos, CS., do Nascimento, SL., et al.[2022]

In a study of 124 sedentary pregnant women, those who engaged in stretching exercises showed better adherence to the exercise program compared to those who walked, especially as pregnancy progressed.

Stretching exercises resulted in lower heart rates and blood pressure compared to walking, suggesting that stretching may be more effective in reducing preeclampsia risk factors for sedentary pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to walking or stretching, and risk of preeclampsia in sedentary pregnant women. Yeo, S.[2021]

Regular prenatal exercise may help prevent or reduce the severity of preeclampsia, a condition affecting 2-7% of pregnancies and linked to serious health risks for mothers and babies.

The protective effects of exercise could be due to mechanisms such as improved placental growth, reduced oxidative stress, and reversal of maternal endothelial dysfunction, highlighting the need for further research to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of regular physical activity in preeclampsia prevention. Weissgerber, TL., Wolfe, LA., Davies, GA.[2019]

Exercise during pregnancy significantly reduces the risk of gestational diabetes mellitus (GDM) by 34%, based on a meta-analysis of 18 studies involving healthy pregnant women.

While exercise did not show a clear effect on reducing preeclampsia overall, mind-body and low-intensity exercises may be beneficial, indicating that certain types of exercise could help lower this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Exercise during Pregnancy on Gestational Diabetes Mellitus, Preeclampsia, and Spontaneous Abortion among Healthy Women-A Systematic Review and Meta-Analysis. Paulsen, CP., Bandak, E., Edemann-Callesen, H., et al.[2023]

Women who experienced severe pre-eclampsia showed significantly lower cardiorespiratory fitness (CRF) and physical activity levels seven years later, with VO2peak values of 31.4 mL·kg-1·min-1 compared to 39.1 mL·kg-1·min-1 in controls.

A substantial portion of these women (34%) did not meet the World Health Organization's physical activity recommendations, indicating a need for targeted clinical follow-up and exercise interventions to improve their long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory fitness in women after severe pre-eclampsia. Gronningsaeter, L., Estensen, ME., Skulstad, H., et al.[2023]

Exercise training may play a protective role against the development of preeclampsia, a serious condition characterized by high blood pressure and protein in the urine during pregnancy.

Recent animal studies suggest that prenatal and gestational exercise can eliminate many features of preeclampsia, indicating potential mechanisms that could be beneficial for pregnant women at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of exercise training on preeclampsia: potential preventive mechanisms. Genest, DS., Falcao, S., Gutkowska, J., et al.[2022]

In a study of 42 women with a history of preeclampsia, 16 weeks of aerobic exercise led to significant improvements in endothelial function and reduced oxidative stress biomarkers.

The improvement in endothelial function was closely linked to increased total antioxidant capacity, suggesting that enhancing antioxidant levels may be a key mechanism through which exercise benefits these women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response of endothelial function and oxidative stress after supervised aerobic exercise training in formerly preeclamptic women. Sun, W., Liu, B., Zheng, H.[2023]

In a study involving 106 pregnant women in Tunisia, those with preeclampsia were found to engage in more sedentary activities compared to healthy controls, suggesting that lower physical activity levels may be linked to the development of this condition.

The research indicates that increased physical activity during pregnancy is associated with longer pregnancy duration, which is a positive indicator of maternal and fetal health, highlighting the importance of exercise in preventing preeclampsia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased physical activity is correlated with improved pregnancy outcomes in women with preeclampsia: A retrospective study. Raguema, N., Benletaifa, D., Mahjoub, T., et al.[2021]

After 12 weeks of exercise training, women who had preeclampsia showed significant improvements in metabolic syndrome components, endothelial function, and vascular health, although they did not fully normalize compared to healthy controls.

Despite the benefits of exercise, women with a history of preeclampsia still exhibited higher cardiovascular risk markers than their healthy counterparts, indicating a need for ongoing monitoring and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular effects of aerobic exercise training in formerly preeclamptic women and healthy parous control subjects. Scholten, RR., Thijssen, DJ., Lotgering, FK., et al.[2022]

Citations

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Exercise or other physical activity for preventing pre ... It has been suggested that exercise may help prevent pre‐eclampsia and its complications. Possible adverse effects of increased physical activity during ...

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Impact of Exercise Training on Preeclampsia | Hypertension A recent animal study demonstrated that many preeclampsia features can be eliminated with prenatal followed by gestational exercise training.

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Physical activity and pregnancy outcomes: An expert review Although physical activity is safe during pregnancy and may reduce excessive gestational weight gain and resultant pregnancy complications, further research is ...

4. nature.com nature.com/articles/s41598-025-94492-2

Physical activity during pregnancy and pregnancy related ... The finding of this study showed that pregnancy-related complications, specifically HDP and GDM, were low in women who had vigorous physical activities during ...

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Aerobic Exercise Training in Formerly Preeclamptic Women These results demonstrate that 12 weeks of aerobic exercise training improve venous reserve in postpartum women. Training normalized plasma ...

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Recreational Physical Activity During Pregnancy and Risk ... Women who engaged in any regular physical activity during early pregnancy, compared with inactive women, experienced a 35% reduced risk of preeclampsia.

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Recreational Physical Activity and the Risk of Preeclampsia A review of the literature on this topic finds that leisure-time physical activity has a clear protective effect on the development of preeclampsia.

8. jacc.org jacc.org/doi/10.1016/j.jacadv.2025.101776

Perinatal Exercise and Cardiovascular Disease Risk Physical activity (PA) or exercise is associated with lower risk of novel and traditional cardiovascular disease (CVD) risk factors in the ...

9. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2020/04/physical-activity-and-exercise-during-pregnancy-and-the-postpartum-period

Physical Activity and Exercise During Pregnancy and the ... Physical activity and exercise in pregnancy are associated with minimal risks and have been shown to benefit most women.