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

Phase 1

Completed

• Conditions: Pre-eclampsia; Hypertension, Pregnancy-Induced; Pregnancy, High-Risk
• Interventions: Other: Exercise using stationary bicycle

• Registration Number: NCT01395342
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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.

Detailed Description

Significance was assumed as p\<.5%.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2011-07-04
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-15
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-11
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
blood pressure and heart rate data	Exercise using stationary bicycle	-

Primary Outcome Measures

Name	Time	Method
Risk to development pre-eclampsia	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital da Mulher Professor Doutor José Aristodemo Pinotti - CAISM/UNICAMP; 🇧🇷 Campinas, São Paulo, Brazil