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

Pre-eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395342
• Other study ID #: 08/2011/PC
• Status: Completed
• Phase: Phase 1
• First received: July 4, 2011
• Last updated: July 11, 2012
• Start date: January 2008
• Est. completion date: November 2011

Study information

• Verified date: July 2012
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Significance was assumed as p<.5%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Eclampsia
• Hypertension, Pregnancy-Induced
• Pre-eclampsia
• Pregnancy, High-Risk

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital da Mulher Professor Doutor José Aristodemo Pinotti - CAISM/UNICAMP	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Types of birth	Parturition data will be analyzed.	up to 28 weeks	Yes
Secondary	Perinatal outcomes	Number of participants with adverse events. Prematurity by CAPURRO method, APGAR score to measure the health of newborn.	up to 28 weeks	Yes