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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jose Luiz Pinto e Silva, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01395342
First received: July 4, 2011
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Pre-eclampsia
Hypertension, Pregnancy-Induced
Pregnancy, High-Risk
 Other: Exercise using stationary bicycle
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Risk to development pre-eclampsia [ Time Frame: up to 28 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Types of birth [ Time Frame: up to 28 weeks ] [ Designated as safety issue: Yes ]
    Parturition data will be analyzed.

  • Perinatal outcomes [ Time Frame: up to 28 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events. Prematurity by CAPURRO method, APGAR score to measure the health of newborn.


Enrollment: 116
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Significance was assumed as p<.5%.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

No publications provided

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
Study First Received: July 4, 2011
Last Updated: July 11, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Campinas, Brazil:
Pregnant women
Pre-eclampsia
Exercise
Hypertension, Pregnancy-Induced
Parturition

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

ClinicalTrials.gov processed this record on May 23, 2013