Promoting Stretching Exercise to Reduce Cardiovascular Health Risk in Late Pregnant Women With Obesity

University of North Carolina, Chapel Hill224 enrolled

Overview

The purpose of this trial is to determine whether a stretching intervention is superior to a usual care control condition (moderate/vigorous activity 30 minutes daily, 5 days per week) for pregnant women from 27 to 37 gestational weeks.

Although being sedentary can lead to excess risk for maternal and child mortality and morbidity, most pregnant women reduce their physical activity and only 8% meet the recommendations in the 3rd trimester. In a prior randomized control trial, it was found that fewer women who stretched developed preeclampsia than did women who walked (3/60 "stretchers" vs. 10/64 "walkers", p=.05). In this study, participants will either receive a stretching intervention

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

224

Conditions

Interventions

Stretching Exercise InterventionBEHAVIORAL

Sequential static stretching of the large skeletal muscle group 5 days per week. Each skeletal group is stretched for 20 seconds for 3 repetitions.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant at less than 24 weeks gestation * Singleton pregnancy * BMI ≥ 30 kg/m\^2 at their first prenatal care visit * English or Spanish speaking Exclusion Criteria: * Women who expect or are scheduled to deliver prior to 37 weeks gestation * Women who expect to move from the area during their participation in the study * Women who are unable to exercise for 30 or more minutes 3 times per week

Locations (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks

Average systolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 5 weeks after baseline (approximately 32 gestational weeks). Three total measurements will be taken, the first will be removed and the second two averaged.

Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)

Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks

Average systolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 10 weeks after baseline (approximately 37 gestational weeks). Three total measurements will be taken, the first will be removed and the second two averaged.

Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)

Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks

Average diastolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 5 weeks after baseline (approximately 32 gestational weeks) Three total measurements will be taken, the first will be removed and the second two averaged.

Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)

Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks

Average diastolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 10 weeks after baseline (approximately 32 gestational weeks). Three total measurements will be taken, the first will be removed and the second two averaged.

Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)

Data from ClinicalTrials.gov

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Change in Sympatho-vagal Balance Projection Period (PEP) for Sympathetic Activity From Baseline (27 Gestational Weeks) to 32 Gestational Weeks

The time in milliseconds from the ECG R point (left ventricular depolarization) and the B-point on the Dz/dt wave form (opening of the aortic valve), assessed at baseline (27 gestational weeks) and 32 gestational weeks.

Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)

Change in Sympatho-vagal Balance Projection Period (PEP) for Sympathetic From Baseline (27 Gestational Weeks) to 37 Gestational Weeks

Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)

Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 32 Gestational Weeks

High frequency of heart rate variability (log(ms\^2/Hz)) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 32 gestational weeks.

Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)

Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 37 Gestational Weeks

High frequency of heart rate variability (log(ms\^2/Hz)) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 37 gestational weeks.

Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)

Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 32 Gestational Weeks

Carotid-femoral pulse wave velocity (PWV) is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness.

Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)

Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 37 Gestational Weeks

Carotid-femoral pulse wave velocity (PWV) is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness.

Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)

Secondary Outcomes

Onset of Preeclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy

Presence of preeclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record.