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

NCT01395342 | Completed Phase 1 DMC

• 1 other identifier: 08/2011/PC
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-eclampsia; Hypertension, Pregnancy-Induced; Pregnancy, High-Risk

Keywords

Pregnant women; Pre-eclampsia; Exercise; Hypertension, Pregnancy-Induced; Parturition

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Types of birth

  up to 28 weeks

• Perinatal outcomes

  up to 28 weeks

Study Arms (1)

blood pressure and heart rate data

NO INTERVENTION

Other: Exercise using stationary bicycle

Interventions

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.

Also known as: incidence of pre-eclampsia, types of birth, perinatal outcomes, blood pressure, heart rate

blood pressure and heart rate data

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant with 12 to 20 weeks gestational
• have chronic blood pressure, previous pre-eclampsia or both
• able to perform a exercise

You may not qualify if:

• multiple pregnancy
• Systemic lupus erythematosus
• heart disease
• neurological disease
• renal failure
• persistent vaginal bleeding
• isthmic-cervical insufficiency

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

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

Campinas, São Paulo, 13083-881, Brazil

Location

Related Publications (1)

• 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.

  PMID: 23997960 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Motor Activity

Interventions

Blood Pressure; Heart Rate

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• João Luiz C Pinto e Silva

  University of Campinas (Unicamp)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 4, 2011
• First Posted: July 15, 2011
• Study Start: January 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 12, 2012

Record last verified: 2012-07

Locations

BR (1)