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

Trial Summary

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.

What data supports the effectiveness of the treatment Exercise Modes, Physical Activity, Aerobic Exercise, Resistance Exercise, Aerobic+Resistance Exercise for Preeclampsia?

Research suggests that regular physical activity, including aerobic exercise, may help reduce the risk of preeclampsia by improving blood vessel function and reducing oxidative stress (damage caused by free radicals). Studies have shown that women who engage in physical activity during pregnancy have a lower incidence of preeclampsia. ^{1 2 3 4 5}

Is exercise safe for pregnant women, including those at risk for preeclampsia?

Research shows that exercise during pregnancy, including aerobic and resistance exercises, is generally safe for pregnant women, even those at risk for preeclampsia. Studies found no increase in adverse events or risks to mothers and babies, and exercise did not affect delivery methods or lead to health complications. ^{6 7 8 9 10}

How does exercise differ from other treatments for preeclampsia?

Exercise as a treatment for preeclampsia is unique because it focuses on physical activity to potentially reduce the risk and effects of the condition, unlike other treatments that may involve medication or early delivery. Studies suggest that exercise can have a protective effect against preeclampsia, offering a non-invasive and natural approach to managing the condition. ^{4 7 9 11 12}

What is the purpose of 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.

Research Team

Linda E May, MS, PhD

Principal Investigator

East Carolina University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Does physical activity in leisure time early in pregnancy reduce the incidence of preeclampsia or gestational hypertension? [2010]

2. United States pubmed.ncbi.nlm.nih.gov

The role of regular physical activity in preeclampsia prevention. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Cardiorespiratory fitness in women after severe pre-eclampsia. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of exercise training on preeclampsia: potential preventive mechanisms. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Response of endothelial function and oxidative stress after supervised aerobic exercise training in formerly preeclamptic women. [2023]

6. Switzerland 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. [2023]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Exercise and physical activity in the prevention of pre-eclampsia: systematic review. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. Netherlands pubmed.ncbi.nlm.nih.gov

Increased physical activity is correlated with improved pregnancy outcomes in women with preeclampsia: A retrospective study. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular effects of aerobic exercise training in formerly preeclamptic women and healthy parous control subjects. [2022]