Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients

NCT01261884 | Completed

• 1 other identifier: 33905
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Pregnancy; Preeclampsia; Exercise

Keywords

Pregnancy; Exercise; Hypertension; Preeclampsia; Resistance exercise

Outcome Measures

Primary Outcomes (1)

• Change in mean arterial blood pressure

  <13 weeks gestation-postpartum visit

Secondary Outcomes (9)

• Hypertension of pregnancy or preeclampsia

• Gestational weight gain

• Neonatal weight

• Proteinuria

• Serum markers for hypertension risk

Study Arms (3)

Routine prenatal care

NO INTERVENTION

Exercise support

EXPERIMENTAL

Behavioral: Exercise support

Exercise intervention

EXPERIMENTAL

Behavioral: Exercise intervention

Interventions

Exercise support BEHAVIORAL

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.

Exercise support

Exercise intervention BEHAVIORAL

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.

Exercise intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Hypertension; Pre-Eclampsia; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Obstetrics and Gynecology and Public Health Sciences

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 16, 2015

Record last verified: 2015-01

Locations

US (1)