Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development
NCT ID: NCT01395342
Last Updated: 2012-07-12
Study Results
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Basic Information
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COMPLETED
PHASE1
116 participants
INTERVENTIONAL
2008-01-31
2011-11-30
Brief Summary
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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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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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blood pressure and heart rate data
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* have chronic blood pressure, previous pre-eclampsia or both
* able to perform a exercise
Exclusion Criteria
* Systemic lupus erythematosus
* heart disease
* neurological disease
* renal failure
* persistent vaginal bleeding
* isthmic-cervical insufficiency
18 Years
45 Years
FEMALE
No
Sponsors
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University of Campinas, Brazil
OTHER
Responsible Party
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Jose Luiz Pinto e Silva
PhD
Principal Investigators
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João Luiz C Pinto e Silva
Role: STUDY_DIRECTOR
University of Campinas (Unicamp)
Locations
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Hospital da Mulher Professor Doutor José Aristodemo Pinotti - CAISM/UNICAMP
Campinas, São Paulo, Brazil
Countries
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References
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Kasawara KT, Burgos CS, do Nascimento SL, Ferreira NO, Surita FG, Pinto E Silva JL. Maternal and Perinatal Outcomes of Exercise in Pregnant Women with Chronic Hypertension and/or Previous Preeclampsia: A Randomized Controlled Trial. ISRN Obstet Gynecol. 2013 Aug 12;2013:857047. doi: 10.1155/2013/857047. eCollection 2013.
Other Identifiers
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08/2011/PC
Identifier Type: -
Identifier Source: org_study_id