Exercise Intervention for Pregnancy

Not currently recruiting at 1 trial location

Overseen By Audrey Martinez, MS, RD, LD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Arkansas Children's Hospital Research Institute

Disqualifiers: Recreational drugs, Tobacco, Alcohol, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 28 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a mother's health and exercise during pregnancy might affect her baby's growth and development. Participants will either follow a specific exercise plan (Exercise Intervention) from early pregnancy until delivery or maintain their usual routine. Pregnant women with a BMI over 30 who are not very active are suitable candidates, provided they have their doctor’s approval to exercise. As an unphased study, this trial offers a unique opportunity to contribute to understanding the impact of maternal health on child development.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this exercise intervention is safe for pregnant women?

Research has shown that physical activity is generally safe for pregnant women and can offer benefits such as fewer pregnancy complications and improved delivery outcomes. Specifically, women who exercised had a higher chance of a normal vaginal delivery compared to those who did not. Regular exercise during pregnancy carries minimal risks and benefits most women.

Experts agree that combining aerobic exercises (activities that increase heart rate) and resistance exercises (activities that build strength) can improve heart and lung health. This benefits both mother and baby. Overall, exercising during pregnancy is well-tolerated and can lead to better health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise intervention for pregnancy because it promotes healthier pregnancies through a non-medical approach. Unlike the standard prenatal care, which often focuses on medical monitoring and nutritional guidance, this intervention encourages physical activity from the 12th week of gestation until delivery. The unique aspect of this approach is its potential to improve maternal and fetal outcomes by enhancing cardiovascular health, reducing the risk of gestational diabetes, and possibly easing labor. This proactive method empowers expectant mothers to play an active role in their well-being, offering a promising complement to traditional prenatal care.

What evidence suggests that this exercise intervention is effective for pregnancy?

Research shows that exercise during pregnancy benefits both the mother and the baby. In this trial, participants in the intervention arm will engage in an exercise program from 12 weeks gestation until delivery. Studies have found that active pregnant women tend to experience better physical and mental health. Exercise also increases the likelihood of a normal vaginal delivery. Moreover, exercising while pregnant is generally safe and can enhance the mother's overall well-being. These findings suggest that exercise is a beneficial activity for expecting mothers. ^{2 3 4 6 7}

Who Is on the Research Team?

Aline Andres, Ph.D

Principal Investigator

UAMS

Are You a Good Fit for This Trial?

The Expecting Study is for pregnant women over 18 with a BMI greater than 30, who are less than 12 weeks into their singleton pregnancy and lead a sedentary lifestyle. They must be cleared to exercise by a doctor and have conceived naturally without fertility treatments. Women with health conditions that could affect the study or those using drugs, tobacco, or alcohol during pregnancy cannot participate.

Inclusion Criteria

BMI >30

I am older than 18 years.

I lead a mostly inactive lifestyle.

Exclusion Criteria

Women with existing medical conditions that could impact the study results, as determined by the person in charge of the study.

Pregnant women who use recreational drugs, tobacco, or alcohol are not eligible.

Women with contraindications to exercise during pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Exercise intervention from 12 weeks gestation until delivery

Approximately 28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention

Trial Overview This trial investigates how an exercise intervention during pregnancy can impact the mother's health as well as her child's growth and development. It aims to understand if staying active while expecting can lead to better outcomes for both mother and baby.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Exercise intervention from 12 week gestation until delivery

Group II: Control Active Control 1 Intervention

Standard of care

Who Is Running the Clinical Trial?

Arkansas Children's Hospital Research Institute

Lead Sponsor

Trials

141

Recruited

5,025,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Exercise interventions during pregnancy significantly reduced gestational weight gain (GWG) by an average of 1.19 kg in women with overweight or obesity, based on a review of seven trials involving 1648 participants.

These interventions also led to a lower incidence of gestational diabetes (GD), with a risk ratio of 0.56, indicating a 44% reduction in the likelihood of developing GD compared to usual prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a structured exercise intervention in gestational weight gain in pregnant women with overweight and obesity: A systematic review with meta-analysis. Bernardo, DS., Carvalho, CB., Conde, M., et al.[2023]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6571580/

Effectiveness of Physical Activity Interventions on ... Overall, studies demonstrated a positive effect of physical activity interventions on the well-being and physical and psychological health of pregnant women.

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0326868

Effects of physical exercise during pregnancy on delivery ... Compared to the control group, pregnant women with exercise interventions had a higher rate of normal vaginal delivery (RR = 1.14, 95% CI: 1.08–1.21, I² = 25.6% ...

3. 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.

4. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-022-00524-z

Physical activity during pregnancy: a systematic review for the ... Benefits for pregnant-women health and well-being were reported while performing aerobic exercise, lumbar stabilization and stretching exercise, water exercise.

5. bmjopensem.bmj.com bmjopensem.bmj.com/content/11/3/e002767

the Active Pregnancy trial SPIRIT 2025-based protocol Few studies have been conducted so far showing positive effects on selected pregnancy outcomes, such as birth weight and depression,12 13 but ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9772147/

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 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0378378216000037

Benefits of aerobic or resistance training during pregnancy ... Pregnant women should be encouraged to perform combined (aerobic + resistance) exercise to improve an important health outcome as is cardiorespiratory fitness.