Exercise Intervention for Pregnancy

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 28 weeks

284 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to determine how a mother's health and physical activity may influence her child's growth and 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 data supports the effectiveness of the treatment Exercise Intervention for Pregnancy?

Research shows that group exercise programs, including aerobic and resistance training, can improve health and fitness outcomes for pregnant women and their newborns. These programs help manage weight gain, reduce the risk of gestational diabetes, and improve overall well-being during pregnancy. ^{1 2 3 4 5}

Is exercise during pregnancy safe for mothers and babies?

Exercise during pregnancy is generally safe for both mothers and babies, with a low risk of serious adverse events. Studies show that pregnant women without medical issues can safely engage in physical activity, which may even offer health benefits for both mother and child. ^{1 4 6 7 8}

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

The exercise intervention for pregnancy is unique because it combines aerobic and resistance training specifically designed for pregnant women, aiming to improve both maternal and newborn health outcomes. Unlike other treatments, it focuses on physical activity to enhance fitness, manage weight, and reduce the risk of gestational diabetes, while also providing social support through group exercise programs. ^{1 4 9 10 11}

Research Team

Aline Andres, Ph.D

Principal Investigator

UAMS

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

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

2. United States 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. [2023]

3. 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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Can Group Exercise Programs Improve Health Outcomes in Pregnant Women? An Updated Systematic Review. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Maternal obesity and physical activity and exercise levels as pregnancy advances: an observational study. [2018]

6. Canada pubmed.ncbi.nlm.nih.gov

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

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

The effect of vigorous exercise during pregnancy. [2008]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

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

Committee Opinion No. 650 Summary: Physical Activity and Exercise During Pregnancy and the Postpartum Period. [2021]

11. France pubmed.ncbi.nlm.nih.gov

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