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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04291560
• Other study ID #: 18-3091
• Secondary ID: 1R01NR017944-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: July 1, 2025

Study information

• Verified date: May 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 306
• Est. completion date: July 1, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Obesity
• Pregnancy Related

Intervention

Behavioral:
• Stretching Exercise Intervention
Sequential static stretching of the large skeletal muscle group 5 days per week. Each skeletal group is stretched for 20 seconds for 3 repetitions.

Locations

Country	Name	City	State
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (27 gestational weeks) and 32 gestational weeks. Three total measurements will be taken, the first will be removed and the second two averaged.	Baseline to 32 gestational weeks
Primary	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 (27 gestational weeks) and 37 gestational weeks. Three total measurements will be taken, the first will be removed and the second two averaged.	Baseline to 37 gestational weeks
Primary	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 (27 gestational weeks) and 32 gestational weeks. Three total measurements will be taken, the first will be removed and the second two averaged.	Baseline to 32 gestational weeks
Primary	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 (27 gestational weeks) and 37 gestational weeks. Three total measurements will be taken, the first will be removed and the second two averaged.	Baseline to 37 gestational weeks
Primary	Change in sympatho-vagal balance projection period (PEP) for sympathetic activity from baseline (27 gestational weeks) to 32 gestational weeks	he 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.	Baseline to 32 gestational weeks
Primary	Change in sympatho-vagal balance projection period (PEP) for sympathetic from baseline (27 gestational weeks) to 37 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 37 gestational weeks.	Baseline to 37 gestational weeks
Primary	Change in high frequency of heart rate variability from baseline (27 gestational weeks) to 32 gestational weeks	High frequency of heart rate variability (reported in absolute value, m^2/Hz) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 32 gestational weeks.	Baseline to 32 gestational weeks
Primary	Change in high frequency of heart rate variability from baseline (27 gestational weeks) to 37 gestational weeks	High frequency of heart rate variability (reported in absolute value, m^2/Hz) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 37 gestational weeks.	Baseline to 37 gestational weeks
Primary	Change in arterial stiffness assessed by SphygmoCor XCEL from baseline (27 gestational weeks) to 32 gestational weeks	Carotid-femoral pulse wave velocity is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness.	Baseline to 32 gestational weeks
Primary	Change in arterial stiffness assessed by SphygmoCor XCEL from baseline (27 gestational weeks) to 37 gestational weeks	Carotid-femoral pulse wave velocity is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness.	Baseline to 37 gestational weeks
Secondary	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.	From baseline (27 weeks gestation) through delivery
Secondary	Onset of eclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy	Presence of eclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record.	From baseline (27 weeks gestation) through delivery
Secondary	Onset of pregnancy induced hypertension anytime between baseline (27 weeks gestation) and the end of pregnancy	Presence of pregnancy induced hypertension anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record.	From baseline (27 weeks gestation) through delivery
Secondary	Onset of gestational diabetes anytime between baseline (27 weeks) and the end of pregnancy	Presence of gestational diabetes anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record.	From baseline (27 weeks gestation) through delivery
Secondary	Preterm delivery at end of pregnancy	Presence of preterm delivery in the electronic medical record.	From baseline (27 weeks gestation) through delivery
Secondary	Elective or emergency cesarean section at end of pregnancy	Presence of an elective or emergency cesarean section in the electronic medical record.	From baseline (27 weeks gestation) through delivery
Secondary	Composite score of Maternal Outcomes at the End of Pregnancy.	The composite score of maternal outcomes (onset of preeclampsia, eclampsia pregnancy induced hypertension, gestational diabetes, preterm delivery, and elective or emergency cesarean section) is obtained at the end of pregnancy. Scores range from 0-6, with higher scores indicating a less healthy pregnancy.	From baseline (27 weeks gestation) through delivery
Secondary	Intrauterine death at end of pregnancy	Presence of an intrauterine death in the electronic medical record.	From baseline (27 weeks gestation) through delivery
Secondary	Child being small for gestational age at the end of pregnancy	Presence of the child being small for gestational age in the electronic medical record.	From baseline (27 weeks gestation) through delivery
Secondary	Child being large for gestational age at the end of pregnancy	Presence of the child being large for gestational age in the electronic medical record.	From baseline (27 weeks gestation) through delivery
Secondary	Neonatal intensive care unit admission at the end of pregnancy	Presence of a neonatal intensive care unit admission in the electronic medical record.	From baseline (27 weeks gestation) through delivery
Secondary	Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy.	The composite score of fetal/neonatal outcomes (intrauterine death, child being small, child being large, neonatal intensive care admission) is obtained at the end of pregnancy. Scores range from 0-4, with higher scores indicating a less healthy fetus/neonate.	From baseline (27 weeks gestation) through delivery