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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

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 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

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

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,543 Previous Clinical Trials
4,248,818 Total Patients Enrolled
65 Trials studying Obesity
58,198 Patients Enrolled for Obesity
National Institute of Nursing Research (NINR)NIH
598 Previous Clinical Trials
10,377,938 Total Patients Enrolled
16 Trials studying Obesity
3,146 Patients Enrolled for Obesity
SeonAe Yeo, PhD, FAANPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Media Library

Stretching Exercise Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04291560 — N/A
Obesity Research Study Groups: Usual Care (Control), Prenatal Heart Smart Intervention
Obesity Clinical Trial 2023: Stretching Exercise Intervention Highlights & Side Effects. Trial Name: NCT04291560 — N/A
Stretching Exercise Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04291560 — N/A
~0 spots leftby Oct 2024
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