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CompletedNCT01261884Updated Jan 16, 2015

Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients

An interventional study of Exercise support and Exercise intervention in Hypertension, Pregnancy and Preeclampsia, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-16.

Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Preeclampsia and other high blood pressure disorders of pregnancy are a significant cause of both maternal and fetal complications of pregnancy. To date, there is no known "cure" for preeclampsia, but studies have shown that exercise may lower the risk of preeclampsia and high blood pressure disorders in pregnancy. Resistance training also lowers blood pressure, and may be easier to perform in a pregnant population, leading to higher compliance. The investigators propose to perform a novel prospective study of a resistance training regimen on blood pressure in pregnant patients at high risk for developing preeclampsia or high blood pressure.

Read the detailed description

Hypertension affects 5-10 percent of pregnancies, and complications from hypertensive disorders of pregnancy are the third leading cause of maternal death in the United States. Hypertensive disorders of pregnancy, including preeclampsia, lead to preterm delivery, morbidity and mortality of mother, fetus, and neonate, and are a predictor of development of chronic maternal hypertension, cardiovascular disease, and renal disease. Maternal obesity is increasing dramatically in the patient population, and is an independent risk factor for hypertension and preeclampsia, increasing the risk by two- to four-fold. To date, no effective preventative measure has been found to reduce the risk of preeclampsia or hypertension in high risk pregnant patients. However, observational studies have shown that patients who exercise or who have increased physical activity before and during pregnancy have lower rates of preeclampsia, hypertension, and gestational diabetes. Exercise has been shown in numerous studies to be safe in pregnancy, and is recommended by the American College of Obstetrics and Gynecology as part of routine prenatal care. However, aerobic exercise can be viewed by patients to be difficult to perform during pregnancy, particularly when the patient is obese and at later gestations. Adherence to exercise regimens is therefore low in this patient group. Dynamic resistance training has been shown to lower mean blood pressure both acutely and long term in non-pregnant hypertensive patients, and can be performed more easily by patients with mobility issues. This intervention has not been studied in an obese pregnant population for its effects on blood pressure throughout pregnancy.

The long term goal is to develop an intervention that will reduce the barriers to exercise of obese pregnant women that will, in turn, reduce their risk of developing preeclampsia and other hypertensive disorders of pregnancy. The specific objective of this proposal is to study the effect of a structured resistance training exercise intervention on blood pressure in obese pregnant woman, who would be considered high risk for development of hypertensive disorders based on pre-pregnancy BMI. The central hypothesis is that obese pregnant patients who participate in a regular, structured resistance training exercise regimen will have a decrease in mean arterial blood pressure compared to obese pregnant patients who are strongly encouraged to do aerobic exercise (lifestyle intervention) or who participate in routine prenatal care. The investigators formulated this hypothesis, in part, based upon previous studies found in the literature performed in non-pregnant hypertensive patients. The investigators will extrapolate from the experience and methods of the collaborators, who have studied the effects of exercise on gestational diabetes.

02

Conditions studied

  • Hypertension
  • Pregnancy
  • Preeclampsia
  • Exercise

Keywords

  • Pregnancy
  • Exercise
  • Hypertension
  • Preeclampsia
  • Resistance exercise
03

In context

Pre-Eclampsia

883 studies on the registry are indexed under Pre-Eclampsia; 238 are open to participants now.

This study's planned enrollment of 66 is below the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patient's BMI must be ≥ 30 and ≤ 40.
  • Established viable singleton pregnancy \<13 weeks

Exclusion criteria

Exclusion Criteria:

  • Multiple gestations.
  • Maternal diabetes established pre-pregnancy by standard guidelines
  • Congenital or acquired heart disease
  • Use of antihypertensive medication
  • Inability to exercise
  • Restrictive lung disease
  • History of shortened/incompetent cervix
  • History of preterm labor
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • No intervention
    Routine prenatal care
  • Experimental
    Exercise support

    Behavioral: Exercise support

  • Experimental
    Exercise intervention

    Behavioral: Exercise intervention

Interventions

  • BehavioralExercise support

    Group B (exercise support) will be given the ACOG pamphlet on exercise in pregnancy, a daily activity log, and a pedometer. This group will be asked to wear the pedometer for 7 consecutive days between Visits 1 and 2, and record daily activities.

  • BehavioralExercise intervention

    Group C (exercise intervention) will be given the ACOG pamphlet on exercise in pregnancy, a daily activity log, a pedometer, a resistance band, and a handout on specific exercises (type and frequency) to be performed. The study coordinator will demonstrate each exercise and then observe the participant perform each exercise to assure full understanding. In addition to wearing the pedometer for 7 days and completing the activity log, this group will also record compliance with the exercise regimen.

06

What researchers measure

Primary outcomes

  1. Change in mean arterial blood pressure

    Time frame: <13 weeks gestation-postpartum visit

Secondary outcomes

  1. Hypertension of pregnancy or preeclampsia

  2. Gestational weight gain

  3. Neonatal weight

  4. Proteinuria

  5. Serum markers for hypertension risk

  6. Activity level

    Measured with activity logos

  7. Number of steps per week

    Pedometer measurement

  8. Weight retention at postpartum visit

  9. Mode of delivery

    Vaginal versus cesarean

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Study locations

1 site
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01261884
Lead sponsor
Milton S. Hershey Medical Center
Responsible party
Richard S. Legro, M.D. (Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center) — Principal investigator
First posted
Dec 17, 2010
Start date
Nov 2010
Primary completion
Jul 2014
Completion
Jan 2015
Last update
Jan 16, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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