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: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Hypertension
Pregnancy
Preeclampsia
Exercise
Behavioral: Exercise support
Behavioral: Exercise intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Exercise Intervention in Pregnancy for Reduction of Blood Pressure in Obese Gravidas

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Change in mean arterial blood pressure [ Time Frame: <13 weeks gestation-postpartum visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 66
Study Start Date: November 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Routine prenatal care
Experimental: Exercise support 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.
Experimental: Exercise intervention 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261884

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01261884     History of Changes
Other Study ID Numbers: 33905
Study First Received: December 16, 2010
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Pregnancy
Exercise
Hypertension
Preeclampsia
Resistance exercise

Additional relevant MeSH terms:
Hypertension
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on September 16, 2014