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

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ClinicalTrials.gov Identifier: NCT01395342
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : July 12, 2012
Sponsor:
Information provided by (Responsible Party):
Jose Luiz Pinto e Silva, 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.


Condition or disease Intervention/treatment Phase
Pre-eclampsia Hypertension, Pregnancy-Induced Pregnancy, High-Risk Other: Exercise using stationary bicycle Phase 1

Detailed Description:
Significance was assumed as p<.5%.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development
Study Start Date : January 2008
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Types of birth [ Time Frame: up to 28 weeks ]
    Parturition data will be analyzed.

  2. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395342


Locations
Brazil
Hospital da Mulher Professor Doutor José Aristodemo Pinotti - CAISM/UNICAMP
Campinas, São Paulo, Brazil, 13083-881
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Study Director: João Luiz C Pinto e Silva University of Campinas (Unicamp)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jose Luiz Pinto e Silva, PhD, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01395342     History of Changes
Other Study ID Numbers: 08/2011/PC
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012

Keywords provided by Jose Luiz Pinto e Silva, University of Campinas, Brazil:
Pregnant women
Pre-eclampsia
Exercise
Hypertension, Pregnancy-Induced
Parturition

Additional relevant MeSH terms:
Hypertension
Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications