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Stretching Exercises for Pregnancy and Obesity

N/A

Waitlist Available

Led By SeonAe Yeo, PhD, FAAN

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Women who are unable to exercise for 30 or more minutes 3 times per week

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (27 weeks gestation) through 8 weeks following delivery

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of a stretching intervention versus moderate/vigorous activity on pregnant women.

Who is the study for?

This trial is for pregnant women with obesity, carrying one baby and less than 24 weeks into their pregnancy. They should have a BMI of 30 or higher at their first prenatal visit and must speak English or Spanish. It's not for those who plan to give birth before 37 weeks, move away during the study, or can't exercise regularly.

What is being tested?

The trial is testing if stretching exercises are better than the usual care (moderate to vigorous activity for 30 minutes daily, five days a week) in reducing cardiovascular risks in obese pregnant women between their 27th and 37th gestational weeks.

What are the potential side effects?

Stretching exercises are generally safe but may include muscle soreness or strain. The risk of serious side effects is low compared to more strenuous activities, especially when tailored for late-stage pregnancy.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot exercise for 30 minutes or more three times a week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (27 weeks gestation) through 8 weeks following delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (27 weeks gestation) through 8 weeks following delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (27 weeks gestation) through 8 weeks following delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in arterial stiffness assessed by SphygmoCor XCEL from baseline (27 gestational weeks) to 32 gestational weeks

Change in arterial stiffness assessed by SphygmoCor XCEL from baseline (27 gestational weeks) to 37 gestational weeks

Change in diastolic blood pressure from baseline (27 gestational weeks) to 32 gestational weeks

+7 more

Secondary study objectives

Child being large for gestational age at the end of pregnancy

Child being small for gestational age at the end of pregnancy

Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy.

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prenatal Heart Smart InterventionExperimental Treatment1 Intervention

This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, the group will complete a sequential static stretching exercise 5 days per week for 10 weeks. The stretching exercise consists of 20 seconds of stretching, for 3 repetitions per muscle group.

Group II: Usual Care (Control)Active Control1 Intervention

This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, this group will complete moderate-intensity walking 5 days per week for 10 weeks in accordance to usual care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stretching Exercise Intervention

2013

N/A

~40

0 / 1Eligibility criteria met