NCT01395342

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Pre-eclampsia
• Hypertension, Pregnancy-Induced
• Pregnancy, High-Risk

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-07-15
• Last updated: 2012-07-12

Locations

1 site across 1 country: Brazil