Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development
Primary Purpose
Pre-eclampsia, Hypertension, Pregnancy-Induced, Pregnancy, High-Risk
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Exercise using stationary bicycle
Sponsored by
About this trial
This is an interventional prevention trial for Pre-eclampsia focused on measuring Pregnant women, Pre-eclampsia, Exercise, Hypertension, Pregnancy-Induced, Parturition
Eligibility 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
Sites / Locations
- Hospital da Mulher Professor Doutor José Aristodemo Pinotti - CAISM/UNICAMP
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
blood pressure and heart rate data
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Types of birth
Parturition data will be analyzed.
Perinatal outcomes
Number of participants with adverse events. Prematurity by CAPURRO method, APGAR score to measure the health of newborn.
Full Information
NCT ID
NCT01395342
First Posted
July 4, 2011
Last Updated
July 11, 2012
Sponsor
University of Campinas, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT01395342
Brief Title
Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development
Official Title
Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Significance was assumed as p<.5%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-eclampsia, Hypertension, Pregnancy-Induced, Pregnancy, High-Risk
Keywords
Pregnant women, Pre-eclampsia, Exercise, Hypertension, Pregnancy-Induced, Parturition
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
blood pressure and heart rate data
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Exercise using stationary bicycle
Other Intervention Name(s)
incidence of pre-eclampsia, types of birth, perinatal outcomes, blood pressure, heart rate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Risk to development pre-eclampsia
Description
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.
Time Frame
up to 28 weeks
Secondary Outcome Measure Information:
Title
Types of birth
Description
Parturition data will be analyzed.
Time Frame
up to 28 weeks
Title
Perinatal outcomes
Description
Number of participants with adverse events. Prematurity by CAPURRO method, APGAR score to measure the health of newborn.
Time Frame
up to 28 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Luiz C Pinto e Silva
Organizational Affiliation
University of Campinas (Unicamp)
Official's Role
Study Director
Facility Information:
Facility Name
Hospital da Mulher Professor Doutor José Aristodemo Pinotti - CAISM/UNICAMP
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083-881
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23997960
Citation
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.
Results Reference
derived
Learn more about this trial
Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development
We'll reach out to this number within 24 hrs