Exercise for Healthy Pregnancy

Overseen By Linda E May, MS, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: East Carolina University

Must not be taking: Oral hypertensives, Insulin

Disqualifiers: BMI ≥25, Multi fetal pregnancy, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

Duration: 20 weeks

268 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of exercise during pregnancy can benefit heart and metabolic health for both mothers and their babies. The study compares aerobic exercise (such as treadmill use), resistance exercise (such as weight lifting), a combination of both, and no exercise. Healthy pregnant women with a single baby and a normal body weight may be suitable participants, especially if their doctor has cleared them to exercise. The goal is to determine which type of exercise best improves health outcomes for mothers and their infants. As an unphased trial, this study provides a unique opportunity to enhance understanding of optimal exercise practices for pregnant women and their babies.

Will I have to stop taking my current medications?

The trial requires that participants do not use certain medications, such as oral hypertensive drugs and insulin. If you are taking these medications, you may need to stop them to participate in the study.

What prior data suggests that these exercise modes are safe for healthy pregnant women?

Research has shown that exercising during pregnancy is generally safe for both the mother and the baby. Studies indicate that aerobic exercises, such as walking or using a treadmill, carry minimal risks and can benefit pregnancy by lowering the chances of complications like early birth and high blood pressure.

Resistance exercises, such as lifting weights or using resistance bands, are also safe for pregnant women. Research suggests they do not harm the mother or baby and can support a healthy pregnancy.

Exercises that combine aerobic and resistance activities are considered safe as well. Studies have found that these do not increase the risk of negative outcomes for the baby.

Overall, these types of exercises are safe and beneficial for most pregnant women. They adhere to safety guidelines set by major health organizations, ensuring both safety and health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of different exercise modes on a healthy pregnancy, something not commonly emphasized in standard prenatal care. While traditional advice for pregnant women often includes general guidelines for staying active, this trial specifically examines aerobic, resistance, and combination exercise routines, each tailored to meet established guidelines by major health organizations. By comparing these exercise modes, researchers hope to uncover how each approach uniquely benefits maternal and fetal health, potentially leading to more personalized and effective exercise recommendations for expectant mothers.

What evidence suggests that this trial's exercise modes could be effective for improving maternal and infant cardiometabolic health?

Research has shown that exercising during pregnancy benefits both mothers and babies. In this trial, participants may join different exercise groups. Aerobic exercises, such as walking or swimming, improve overall health and reduce the risk of early birth or the need for a C-section. Strength exercises, like lifting light weights, help control weight gain, reduce pain, and enhance mood. Combining both exercise types can improve heart and lung health and provide general health benefits. These findings suggest that staying active during pregnancy leads to better health for both mothers and their babies. ^{1 2 5 6 7}

Who Is on the Research Team?

Linda May, MS, PhD

Principal Investigator

East Carolina University

Are You a Good Fit for This Trial?

This trial is for healthy pregnant women interested in how different types of exercise might affect their and their baby's heart health and growth. Women must have a normal weight before pregnancy to join. Details on who can't participate are not provided.

Inclusion Criteria

I am pregnant with one baby and less than 16 weeks along.

BMI: 18.5 to 24.4

Clearance by Obstetric provider for exercise

Exclusion Criteria

BMI ≥25

Unable or Unwilling to provide consent

Multi fetal pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pregnant women are randomized to an exercise intervention (aerobic exercise, resistance exercise, aerobic and resistance exercise) or to no exercise (usual care) from 16 to 36 weeks gestation

20 weeks

Weekly sessions

Follow-up

Participants and their infants are monitored for cardiometabolic health and growth trajectories at 1, 6, and 12 months postpartum

12 months

3 visits (in-person) at 1, 6, and 12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Modes

Trial Overview

The study is testing the effects of three kinds of exercise routines during pregnancy: aerobic, resistance, and a combination of both compared to no exercise. It will look at how these exercises impact the mother's and infant's health right after birth up until the baby turns one year old.

How Is the Trial Designed?

Group I: Resistance Exercise (RE) Experimental Treatment 1 Intervention

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. The RE group will perform 12-15 repetitions of 10-12 resistance exercises in a circuit, for 3 sets with rest period of 30-60 seconds between sets as needed.\[100\] Seated isokinetic exercise using Cybex 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 Cybex machines. Core exercises will be performed at the end of the session (i.e. seated side bends).

Group II: Combination Exercise (AERE) Experimental Treatment 1 Intervention

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. The AERE group will switch 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 repeated repeat with different exercises.\[106-108\] The investigators will also calculate the metabolic minutes per week (METmin/wk) of all participants in order to account for potential differences in energy expenditure based on activity, though the dose of 150 min/wk at moderate intensity is held constant between exercise groups.

Group III: Aerobic Exercise (AE) Experimental Treatment 1 Intervention

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. The AE group will exercise on aerobic machines (i.e. treadmill, elliptical, bicycle) for all of their sessions.

Group IV: Control (no exercise) 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

Recent research supports a shift from traditional rest during pregnancy to encouraging active lifestyles, highlighting the health benefits of exercise for pregnant women.

While the specific benefits of combining resistance and aerobic exercises during pregnancy are still being studied, existing evidence shows that resistance training programs do not lead to adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise in Pregnancy and Outcome. Barakat, R., Perales, M.[2017]

A study involving 92 healthy pregnant women showed that moderate-to-vigorous resistance exercise during pregnancy is safe and does not negatively impact the health of the mother or fetus.

Women who participated in resistance exercise had newborns with a higher average birth weight compared to the control group, although this difference was not significant after adjusting for gestational age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of moderate-to-vigorous resistance exercise during pregnancy: a randomized controlled trial. Petrov Fieril, K., Glantz, A., Fagevik Olsen, M.[2022]

A study involving 1348 women showed that a supervised moderate-intensity exercise program during pregnancy significantly reduced the risk of excessive gestational weight gain, gestational hypertension, and diabetes, while also improving the likelihood of returning to pre-pregnancy weight after delivery.

The exercise program also benefited offspring by reducing the risk of macrosomia (large birth weight) and childhood overweight/obesity, suggesting that maternal exercise during pregnancy can have long-term health benefits for both mothers and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gestational Exercise and Maternal and Child Health: Effects until Delivery and at Post-Natal Follow-up. Perales, M., Valenzuela, PL., Barakat, R., et al.[2020]

Engaging in regular physical activity during pregnancy is beneficial for most women, helping to maintain fitness, manage weight, and reduce the risk of gestational diabetes, with a recommended goal of moderate-intensity exercise for 20-30 minutes most days of the week.

While exercise is generally safe, healthcare providers should evaluate women with complications before recommending physical activity, as bed rest is rarely necessary and ambulation is often encouraged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG Committee Opinion No. 650: Physical Activity and Exercise During Pregnancy and the Postpartum Period. [2022]

A systematic review of 61 randomized controlled trials found strong evidence that combined aerobic and resistance training during pregnancy significantly improves maternal cardiorespiratory fitness and helps prevent urinary incontinence.

The combination of aerobic and resistance exercises is identified as the most beneficial exercise modality for maternal health during pregnancy, while other exercise interventions showed weak or insufficient evidence for their benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of aerobic or resistance training during pregnancy on maternal health and perinatal outcomes: A systematic review. Perales, M., Santos-Lozano, A., Ruiz, JR., et al.[2022]

In a study of 388 women followed from around 16 weeks of pregnancy to delivery, participation in aerobic exercise did not negatively impact birthweight or other maternal and infant outcomes.

Women who engaged in regular aerobic exercise reported fewer pregnancy-related discomforts later in their pregnancy, suggesting that exercise may help alleviate some common pregnancy symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise during pregnancy and pregnancy outcome. Sternfeld, B., Quesenberry, CP., Eskenazi, B., et al.[2022]

A systematic review of 74 studies involving 3766 pregnant women found that the serious adverse event rate during exercise is very low, at 1.4 per 10,000 hours of exercise, indicating that exercise is generally safe for healthy pregnant women.

Even when including mild adverse events and fetal heart rate changes, the overall risk remains low at 6.8 per 10,000 hours, suggesting that both previously inactive and active women can safely engage in regular physical activity during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: pregnancy. Charlesworth, S., Foulds, HJ., Burr, JF., et al.[2018]

Supervised exercise during pregnancy significantly reduces the risk of developing hypertensive disorders of pregnancy (HDP), with a pooled incidence of 3% in the exercise group compared to 5% in the control group, based on a meta-analysis of 16 randomized controlled trials involving 5939 pregnant women.

Combining aerobic and anaerobic exercises or practicing yoga showed even greater benefits in preventing HDP compared to aerobic exercise alone, highlighting the importance of structured physical activity for the health of pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Supervised Exercise on the Development of Hypertensive Disorders of Pregnancy: A Systematic Review and Meta-Analysis. Danielli, M., Gillies, C., Thomas, RC., et al.[2022]

Regular physical exercise during pregnancy is safe and beneficial for both the mother and fetus when performed at mild to moderate intensity, yet many pregnant women remain inactive due to safety concerns.

The study provides comprehensive guidelines for healthcare professionals on exercise recommendations for pregnant women, including specific advice for low-risk and special populations, emphasizing the importance of establishing healthy habits during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recommendations for physical exercise practice during pregnancy: a critical review]. do Nascimento, SL., Godoy, AC., Surita, FG., et al.[2019]

In a study of 82 pregnant women, those who participated in a supervised exercise program gained significantly less weight during pregnancy compared to those who received standard prenatal care, indicating that exercise can help manage weight in overweight pregnant women.

The exercise program did not lead to adverse effects on perinatal outcomes, blood pressure, or quality of life, suggesting it is a safe intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an antenatal physical exercise programme on maternal/perinatal outcomes and quality of life in overweight and obese pregnant women: a randomised clinical trial. Nascimento, SL., Surita, FG., Parpinelli, MÂ., et al.[2022]

Pregnant women are recommended to engage in aerobic exercises, such as walking or biking for 30 minutes, three times a week, and strength training one to two times a week, to promote both physical and psychological health.

Regular physical exercise during pregnancy can help prevent and manage complications like gestational diabetes and excessive weight gain, highlighting the importance of exercise education for pregnant women and their healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[International recommandations on physical exercise for pregnant women]. Filhol, G., Bernard, P., Quantin, X., et al.[2022]

Engaging in a supervised exercise program during pregnancy does not reduce maternal weight gain but is linked to a higher rate of weight loss (68.2% vs 42.8%) at 6 weeks postpartum, suggesting potential long-term benefits for mothers.

Exercise during pregnancy is associated with improved fetal cardiac function, as indicated by higher ductus arteriosus pulsatility index and ejection fraction at specific gestational weeks, which may reflect beneficial adaptations in fetal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does exercise during pregnancy impact on maternal weight gain and fetal cardiac function? A randomized controlled trial. Brik, M., Fernández-Buhigas, I., Martin-Arias, A., et al.[2021]

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