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

Study Overview
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Brief Summary
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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
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Significance was assumed as p<.5%.

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

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

Intervention / Treatment
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* Other: Exercise using stationary bicycle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: blood pressure and heart rate data<br> | Other: Exercise using stationary bicycle<br>* 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.<br>* Other names: heart rate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk to development pre-eclampsia | 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 | Parturition data will be analyzed. | up to 28 weeks | 
| Perinatal outcomes | Number of participants with adverse events. Prematurity by CAPURRO method, APGAR score to measure the health of newborn. | up to 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnant women, Pre-eclampsia, Exercise, Hypertension, Pregnancy-Induced, Parturition