Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01261884
First received: December 16, 2010
Last updated: October 9, 2014
Last verified: October 2014

December 16, 2010
October 9, 2014
November 2010
July 2014   (final data collection date for primary outcome measure)
Change in mean arterial blood pressure [ Time Frame: <13 weeks gestation-postpartum visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01261884 on ClinicalTrials.gov Archive Site
  • Hypertension of pregnancy or preeclampsia [ Designated as safety issue: No ]
  • Gestational weight gain [ Designated as safety issue: No ]
  • Neonatal weight [ Designated as safety issue: No ]
  • Proteinuria [ Designated as safety issue: No ]
  • Serum markers for hypertension risk [ Designated as safety issue: No ]
  • Activity level [ Designated as safety issue: No ]
    Measured with activity logos
  • Number of steps per week [ Designated as safety issue: No ]
    Pedometer measurement
  • Weight retention at postpartum visit [ Designated as safety issue: No ]
  • Mode of delivery [ Designated as safety issue: No ]
    Vaginal versus cesarean
Same as current
Not Provided
Not Provided
 
Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients
Exercise Intervention in Pregnancy for Reduction of Blood Pressure in Obese Gravidas

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hypertension
  • Pregnancy
  • Preeclampsia
  • Exercise
  • Behavioral: Exercise 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.
  • Behavioral: Exercise 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.
  • No Intervention: Routine prenatal care
  • Experimental: Exercise support
    Intervention: Behavioral: Exercise support
  • Experimental: Exercise intervention
    Intervention: Behavioral: Exercise intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
66
February 2015
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01261884
33905
No
Richard S. Legro, M.D., Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Not Provided
Not Provided
Milton S. Hershey Medical Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP