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Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients

Primary Purpose

Hypertension, Pregnancy, Preeclampsia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise support
Exercise intervention
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Pregnancy, Exercise, Hypertension, Preeclampsia, Resistance exercise

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Routine prenatal care

Exercise support

Exercise intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in mean arterial blood pressure

Secondary Outcome Measures

Hypertension of pregnancy or preeclampsia
Gestational weight gain
Neonatal weight
Proteinuria
Serum markers for hypertension risk
Activity level
Measured with activity logos
Number of steps per week
Pedometer measurement
Weight retention at postpartum visit
Mode of delivery
Vaginal versus cesarean

Full Information

First Posted
December 16, 2010
Last Updated
January 15, 2015
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01261884
Brief Title
Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients
Official Title
Exercise Intervention in Pregnancy for Reduction of Blood Pressure in Obese Gravidas
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pregnancy, Preeclampsia, Exercise
Keywords
Pregnancy, Exercise, Hypertension, Preeclampsia, Resistance exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine prenatal care
Arm Type
No Intervention
Arm Title
Exercise support
Arm Type
Experimental
Arm Title
Exercise intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exercise support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean arterial blood pressure
Time Frame
<13 weeks gestation-postpartum visit
Secondary Outcome Measure Information:
Title
Hypertension of pregnancy or preeclampsia
Title
Gestational weight gain
Title
Neonatal weight
Title
Proteinuria
Title
Serum markers for hypertension risk
Title
Activity level
Description
Measured with activity logos
Title
Number of steps per week
Description
Pedometer measurement
Title
Weight retention at postpartum visit
Title
Mode of delivery
Description
Vaginal versus cesarean

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients

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