Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development

July 11, 2012 updated by: Jose Luiz Pinto e Silva, University of Campinas, Brazil

Introduction:

Hypertensive disorders during pregnancy are an important issue in global public health. It is current the leading cause of maternal mortality in Brazil.

Objective:

To assess the effect of physical exercise using stationary bicycle through blood pressure and heart rate measurements, incidence of pre-eclampsia and quality of life survey in pregnant women with chronic high blood pressure, previous preeclampsia pregnancies or both factors associated comparing to a group with no intervention. Verify the type of births, maternal and perinatal outcomes in both groups. Methodology: This randomized clinical trial enrolled pregnant women presenting chronic hih blood pressure, previous pre-eclampsia experience or both. Women from 12 to 20 gestational weeks were selected from the prenatal outpatient clinic and randomly allocated to the study or non-interventional group. Women at the study group performed physical exercise using stationary bicycle (horizontal bench model) during 20 minutes, once a week. The heart rate was maintained at 20% above resting heart rate and up to 140 bpm. Blood pressure and heart rate measurements were evaluated before and after exercise. The non-intervention group followed regular prenatal routine with weekly returns for heart rate and blood pressure measurements. Both groups fulfilled the quality of life survey (SF-36 questionnaire) at three times: between 12 and 20 weeks; 28 and 32 weeks and 36 and 41 weeks of gestation. After that data of parturition will be analyzed to compare the incidence of pre-eclampsia, types of birth, maternal and perinatal outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Significance was assumed as p<.5%.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-881
        • Hospital da Mulher Professor Doutor José Aristodemo Pinotti - CAISM/UNICAMP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant with 12 to 20 weeks gestational
  • have chronic blood pressure, previous pre-eclampsia or both
  • able to perform a exercise

Exclusion Criteria:

  • multiple pregnancy
  • Systemic lupus erythematosus
  • heart disease
  • neurological disease
  • renal failure
  • persistent vaginal bleeding
  • isthmic-cervical insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: blood pressure and heart rate data
Other: Exercise using stationary bicycle

Before exercise, blood pressure and heart rate are measured in the sitting position.

Exercise is realized using stationary bicycle (horizontal bench mode) once at week, during 20 minutes under physiotherapist supervision.

The heart rate was maintained at 20% above resting heart rate and up to 140 bpm.

After exercise is performed a leg stretching and a low back stretching. The blood pressure and heart rate are measured in the sitting position.

Other Names:
  • blood pressure
  • heart rate
  • incidence of pre-eclampsia
  • types of birth
  • perinatal outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk to development pre-eclampsia
Time Frame: up to 28 weeks
The comparison between groups will be by the diagnosis of pre-eclampsia. Pre-eclampsia is diagnosed after 20 week of gestation with systolic blood pressure equal to or greater than 140 mmHg, diastolic blood pressure equal to or greater than 90 mmHg and proteinuria greater than or equal 0.3 g/d by 24 hour urine collection.
up to 28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Types of birth
Time Frame: up to 28 weeks
Parturition data will be analyzed.
up to 28 weeks
Perinatal outcomes
Time Frame: up to 28 weeks
Number of participants with adverse events. Prematurity by CAPURRO method, APGAR score to measure the health of newborn.
up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Investigators

  • Study Director: João Luiz C Pinto e Silva, University of Campinas (UNICAMP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

July 4, 2011

First Submitted That Met QC Criteria

July 13, 2011

First Posted (Estimate)

July 15, 2011

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/2011/PC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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