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

University of Campinas, Brazil

Status and phase: Completed; Phase 1

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

Treatments: Other: Exercise using stationary bicycle

Study type: Interventional

Funder types: Other

Identifiers

NCT01395342

08/2011/PC

Details and patient eligibility

About

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.

Full description

Significance was assumed as p<.5%.

Enrollment: 116 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

blood pressure and heart rate data

No Intervention group

Treatment:

Other: Exercise using stationary bicycle