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

Trial Summary

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

Research shows that exercise during pregnancy can reduce the risk of excessive weight gain, high blood pressure, and diabetes in mothers, and it can also lower the risk of having a large baby and childhood obesity. Exercise is safe and helps mothers return to their pre-pregnancy weight more easily. ^{1 2 3 4 5}

Is exercise safe during pregnancy?

Exercise during pregnancy is generally safe for healthy women without contraindications (medical reasons to avoid it). Studies show a low risk of serious adverse events, with only 1.4 serious events per 10,000 hours of exercise. Mild events and changes in fetal heart rate are slightly more common, but overall, exercise is considered low-risk and can even reduce pregnancy discomforts. ^{1 3 6 7 8}

How does the exercise treatment for a healthy pregnancy differ from other treatments?

The exercise treatment for a healthy pregnancy is unique because it combines aerobic and resistance exercises, which are shown to be safe and beneficial for pregnant women. This approach not only helps in maintaining physical fitness but also reduces the risk of complications like gestational diabetes and hypertensive disorders, unlike traditional advice of rest during pregnancy. ^{6 9 10 11 12}

What is the purpose of this trial?

The overall objective of this proposal is to conduct a longitudinal prospective study of healthy pregnant women and their offspring to determine which antenatal maternal exercise mode(s) will have the greatest impact on maternal and infant cardiometabolic health. This information may lead to modified clinical practice recommendations that improve health in childhood and possibly beyond. This randomized controlled trial will recruit 268 healthy pregnant women randomized to an exercise intervention (aerobic exercise, resistance exercise, aerobic and resistance exercise) or to no exercise (usual care); their infants will be measured at 1, 6, and 12 months of age. This rigorous design will test our central hypothesis that aerobic and resistance exercise and resistance exercise training during pregnancy will, in healthy weight BMI (HW) women, improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. We will test this hypothesis with two specific aims: Aim 1. Determine the influence of different exercise modes during HW pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by HW pregnant women will improve offspring neuromotor and cardiometabolic measures at 1, 6, and 12 months postpartum (e.g. decreased % body fat, BMI z-score, heart rate, non-HDL, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of HW pregnant women that do not exercise; AERE and RE will have the greatest impact on improving infant measures. Aim 2. Determine the most effective exercise mode in HW pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by HW pregnant women will improve both maternal cardiometabolic health measures (e.g. decreased BMI z-score, non-HDL, % body fat, HR, weight gain) across pregnancy (16 to 36 weeks gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestation) compared to HW pregnant women that do not exercise; AERE and RE will have the greatest impact on improving maternal health measures, with the AERE group having the highest compliance. The proposed innovative study will be the first to provide a critical understanding of the influence of antenatal exercise modes upon the cardiometabolic health and growth trajectories of offspring who may be at increased risk of poor outcomes. This work will have a significant impact on reducing the cycle of OB and CVD, potentially providing the earliest and most efficacious intervention to attenuate or prevent OB and CVD in the next generation.

Research Team

Linda May, MS, PhD

Principal Investigator

East Carolina University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

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

The efficacy of moderate-to-vigorous resistance exercise during pregnancy: a randomized controlled trial. [2022]

2. England 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. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Benefits of aerobic or resistance training during pregnancy on maternal health and perinatal outcomes: A systematic review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Does exercise during pregnancy impact on maternal weight gain and fetal cardiac function? A randomized controlled trial. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Gestational Exercise and Maternal and Child Health: Effects until Delivery and at Post-Natal Follow-up. [2020]

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

Resistance Exercise in Pregnancy and Outcome. [2017]

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

Exercise during pregnancy and pregnancy outcome. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: pregnancy. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Supervised Exercise on the Development of Hypertensive Disorders of Pregnancy: A Systematic Review and Meta-Analysis. [2022]

10. France pubmed.ncbi.nlm.nih.gov

[International recommandations on physical exercise for pregnant women]. [2022]

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

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

12. Brazil pubmed.ncbi.nlm.nih.gov

[Recommendations for physical exercise practice during pregnancy: a critical review]. [2019]