Exercise Program "Expecting" for Pregnancy

Overseen By Taren Swindle, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Arkansas Children's Hospital Research Institute

Disqualifiers: Preeclampsia, Illicit drug use, others

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

Compensation: Varies

Number of Visits: 3

Duration: 38 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an exercise program designed for pregnant women to determine its practicality and acceptance in the community. The program includes three weekly sessions of moderate exercise, such as walking or biking, and strength training. Women with a body mass index over 30, who are between 11-15 weeks pregnant, and not currently meeting exercise guidelines might be suitable candidates. Participants in the test group will work with a personal trainer to stay active, while others will follow their usual doctor's advice. The trial aims to ensure the exercise program is easily accessible and beneficial for expecting mothers in their local area.

As an unphased study, this trial provides a unique opportunity for pregnant women to contribute to research that could enhance prenatal health and wellness in their communities.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise program is safe for expecting mothers?

Research has shown that exercise during pregnancy is usually safe and beneficial for most women. Staying active helps manage weight and lowers the risk of pregnancy complications. Studies indicate that exercise does not increase the chances of miscarriage, low birth weight, or early delivery. It might even lead to more normal vaginal births and fewer C-sections. Overall, pregnant women generally tolerate physical activity well, making it a safe option when done correctly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Expecting" exercise program for pregnancy because it offers a structured and community-based approach to prenatal fitness, which is not typically emphasized in standard care. Unlike traditional advice that often leaves pregnant individuals to manage their own exercise, this program provides in-person sessions with personal trainers who tailor the intensity and ensure safety using the Borg scale of exhaustion. Moreover, the program encourages daily activity with a target of 10,000 steps, tracked and reviewed regularly, offering a more engaged and supportive fitness experience for expectant mothers.

What evidence suggests that the "Expecting" exercise program is effective for pregnancy?

This trial will compare an exercise program specifically designed for pregnancy with standard care. Research has shown that exercising during pregnancy can be very beneficial. It can reduce the likelihood of needing a cesarean section (C-section) and help control weight for both mother and baby. Exercise is also associated with a higher chance of normal vaginal delivery and can shorten labor. Additionally, it helps manage gestational diabetes, a type of diabetes that can develop during pregnancy. Overall, regular physical activity during pregnancy is considered safe and beneficial for most women. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for expecting mothers with a single pregnancy, between 11-15 weeks along, who are overweight (BMI > 30) and lead a sedentary lifestyle. They must be cleared by their physician to participate. Women with conditions like preeclampsia or placenta previa, drug use issues, or other health concerns that make exercise unsafe cannot join.

Inclusion Criteria

(b) singleton pregnancy,

I do not engage in physical activity and have a desk job.

(c) between 11-15 weeks of pregnancy (at enrollment),

Exclusion Criteria

(a) contraindications for exercise (preeclampsia-eclampsia, premature rupture of the membranes, antepartum hemorrhage, placenta previa, multiple gestation and other defined conditions)

You use illegal drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Adaptation

Adaptation of the Expecting intervention to community settings using the REP framework

Varies

Treatment

Participants engage in community-adapted exercise sessions, including aerobic and resistance training, with monitoring of daily step count

38 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for changes in BMI, blood pressure, and cholesterol from baseline to delivery and 6 months post-delivery

6 months post-delivery

What Are the Treatments Tested in This Trial?

Interventions

• Exercise in Pregnancy

Trial Overview The study tests the translation of the 'Expecting' intervention from clinical settings to community delivery. It aims to assess if this exercise program can be feasibly and effectively implemented in community settings for pregnant women.

How Is the Trial Designed?

Group I: Exercise in Pregnancy in Community Experimental Treatment 1 Intervention

The Expecting intervention at the ACNC includes three 30-45 minute, in-person exercise sessions per week. The sessions are gradually increased in length over the first weeks of participation, and are comprised of 15-30 minutes of moderate aerobic activity (recumbent bike, walking on a treadmill or on an elliptical machine) as well as 5-10 minutes of resistance training using hydraulic exercise equipment. The sessions conclude with stretching exercises. Throughout the session, a personal trainer assesses the rating of perceived exertion using the 6 to 20 point Borg scale of exhaustion.41 Between sessions, participants are asked to monitor their daily step count with a target of 10,000 steps per day using a pedometer provided to the participant. This number is reported to or downloaded by the personal trainer at each in-person session. These elements will be adapted to provide a similar exercise experience that is accessible to women in their local community.

Group II: Standard Care Active Control 1 Intervention

Participants will receive guidance on exercise from their physician as usual.

Who Is Running the Clinical Trial?

Arkansas Children's Hospital Research Institute

Lead Sponsor

Trials

141

Recruited

5,025,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4622376/

Exercise in Pregnancy: A Clinical Review - PMC Benefits of exercise in pregnancy include reduction in Cesarean section rates, appropriate maternal and fetal weight gain, and managing gestational diabetes.

2. 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.

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

Effects of physical exercise during pregnancy on delivery ... Physical exercise is associated with an increased likelihood of normal vaginal delivery, a reduced rate of cesarean delivery, and a shorter first stage of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0266613825000828

Women's perceptions of maternal and fetal health benefits ... Walking and yoga were perceived as the most beneficial modalities for both maternal and fetal health, with the outcome expectancies being 9.5 ± 2.1 and 8.8 ± 2 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11706359/

Exercise FITT-V During Pregnancy: Association with Birth ... Studies combining metrics of exercise frequency, duration, and intensity confirm there is no increased risk for adverse birth outcomes in women ...

6. acog.org acog.org/womens-health/faqs/exercise-during-pregnancy

Exercise During Pregnancy It is safe to continue or start regular physical activity. Physical activity does not increase your risk of miscarriage, low birth weight, or early delivery.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK430821/

Pregnancy And Exercise - StatPearls - NCBI Bookshelf - NIH Proper exercise during pregnancy will help with weight loss after delivery. Go to: Other Issues. Exercise is considered safe and beneficial in most pregnancies.

8. 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 ...