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Pregnancy RelatedNCT04291560

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

A study testing Stretching Exercise Intervention in people with Pregnancy Related and Cardiovascular Risk Factor, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Stretching Exercise Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteUnited States
Study dates
1 Mar 2020to 20 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pregnant at less than 24 weeks gestation
  • Singleton pregnancy
  • BMI ≥ 30 kg/m^2 at their first prenatal care visit
  • English or Spanish speaking

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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.

Read the 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

Being tested
Stretching Exercise Intervention
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stretching Exercise InterventionBehavioural

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

Study groups in NCT04291560
Study groupRoleWhat they receive
Prenatal Heart Smart InterventionExperimentalThis 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.
Receives: Behavioral: Stretching Exercise Intervention
Usual Care (Control)No interventionThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

Secondary outcomes (12)
  1. 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.

    Measured: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

  2. 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.

    Measured: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

  3. 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.

    Measured: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

  4. 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.

    Measured: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

  5. Preterm Delivery at End of Pregnancy

    Presence of preterm delivery in the electronic medical record.

    Measured: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

  6. Elective or Emergency Cesarean Section at End of Pregnancy

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

    Measured: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

  7. 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.

    Measured: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

  8. Intrauterine Death at End of Pregnancy

    Presence of an intrauterine death in the electronic medical record.

    Measured: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

  9. 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.

    Measured: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

  10. 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.

    Measured: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

  11. Neonatal Intensive Care Unit Admission at the End of Pregnancy

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

    Measured: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

  12. 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.

    Measured: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start1 Mar 2020
  3. Primary completion23 Oct 2024
  4. Study completion20 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Outcomes assessor
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04291560
Sponsor's protocol ID
18-3091
Other IDs
1R01NR017944-01A1
Status last verified
Jan 2025
First submitted
21 Feb 2020
Last updated
19 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Stretching Exercise Intervention in people with Pregnancy Related and Cardiovascular Risk Factor, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks (time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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