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Completed

NCT Number: NCT01395342

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Hospital da Mulher Professor Doutor José Aristodemo Pinotti - CAISM/UNICAMP

Campinas, São Paulo, 13083-881, Brazil

About this study

Significance was assumed as p<.5%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise using stationary bicycle

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 15, 2011
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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