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

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Primary Purpose

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stretching Exercise Intervention

About this trial

This is an interventional prevention trial for Pregnancy Related

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

The University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prenatal Heart Smart Intervention

Usual Care (Control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

Preterm delivery at end of pregnancy

Presence of preterm delivery in the electronic medical record.

Elective or emergency cesarean section at end of pregnancy

Presence of an elective or emergency cesarean section in the electronic medical record.

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.

Intrauterine death at end of pregnancy

Presence of an intrauterine death in the electronic medical record.

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.

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.

Neonatal intensive care unit admission at the end of pregnancy

Presence of a neonatal intensive care unit admission in the electronic medical record.

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.

Full Information

NCT ID

NCT04291560

First Posted

February 21, 2020

Last Updated

April 17, 2023

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Nursing Research (NINR)

1. Study Identification

Unique Protocol Identification Number

NCT04291560

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

May 31, 2025 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy Related, Cardiovascular Risk Factor, Obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A parallel design will be used, with an equal allocation of 306 obese pregnant women to the two groups: stretching exercise and enhanced usual care.

Masking

Outcomes Assessor

Masking Description

Masking will not be completed in this trial.

Allocation

Randomized

Enrollment

306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prenatal Heart Smart Intervention

Arm Type

Experimental

Arm Description

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.

Arm Title

Usual Care (Control)

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Stretching Exercise Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline to 32 gestational weeks

Title

Change in systolic blood pressure from baseline (27 gestational weeks) to 37 gestational weeks

Description

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.

Time Frame

Baseline to 37 gestational weeks

Title

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

Description

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.

Time Frame

Baseline to 32 gestational weeks

Title

Change in diastolic blood pressure from baseline (27 gestational weeks) to 37 gestational weeks

Description

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.

Time Frame

Baseline to 37 gestational weeks

Title

Change in sympatho-vagal balance projection period (PEP) for sympathetic activity from baseline (27 gestational weeks) to 32 gestational weeks

Description

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.

Time Frame

Baseline to 32 gestational weeks

Title

Change in sympatho-vagal balance projection period (PEP) for sympathetic from baseline (27 gestational weeks) to 37 gestational weeks

Description

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.

Time Frame

Baseline to 37 gestational weeks

Title

Change in high frequency of heart rate variability from baseline (27 gestational weeks) to 32 gestational weeks

Description

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.

Time Frame

Baseline to 32 gestational weeks

Title

Change in high frequency of heart rate variability from baseline (27 gestational weeks) to 37 gestational weeks

Description

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.

Time Frame

Baseline to 37 gestational weeks

Title

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

Description

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

Time Frame

Baseline to 32 gestational weeks

Title

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

Description

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

Time Frame

Baseline to 37 gestational weeks

Secondary Outcome Measure Information:

Title

Onset of preeclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy

Description

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

Time Frame