Pre-eclampsiaPhase 1NCT01395342
Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development
A Phase 1 study testing Exercise using stationary bicycle in people with Pre-eclampsia and Hypertension, Pregnancy-Induced, run by University of Campinas, Brazil at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-eclampsia, Hypertension, Pregnancy-Induced, Pregnancy, High-Risk
- What is being tested?
- Exercise using stationary bicycle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant with 12 to 20 weeks gestational
- have chronic blood pressure, previous pre-eclampsia or both
- able to perform a exercise
Who cannot join
- multiple pregnancy
- Systemic lupus erythematosus
- heart disease
- neurological disease
- renal failure
- persistent vaginal bleeding
- isthmic-cervical insufficiency
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital da Mulher Professor Doutor José Aristodemo Pinotti - CAISM/UNICAMP
Campinas, São Paulo, 13083-881
About this study
Introduction:
Hypertensive disorders during pregnancy are an important issue in global public health. It is current the leading cause of maternal mortality in Brazil.
Read more
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.
Read the detailed description
Significance was assumed as p<.5%.
- Being tested
- Exercise using stationary bicycle
- Keywords
- Pregnant women, Pre-eclampsia, Exercise, Hypertension, Pregnancy-Induced, Parturition
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise using stationary bicycleOther
Also called incidence of pre-eclampsia, types of birth, perinatal outcomes, blood pressure
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.
| Study group | Role | What they receive |
|---|---|---|
| blood pressure and heart rate data | No intervention | Not described Receives: Other: Exercise using stationary bicycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 28 weeks
Secondary outcomes (2)
Types of birth
Parturition data will be analyzed.
Measured: up to 28 weeks
Perinatal outcomes
Number of participants with adverse events. Prematurity by CAPURRO method, APGAR score to measure the health of newborn.
Measured: up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJan 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Luiz Pinto e Silva, University of Campinas, Brazil
- Investigators
- João Luiz C Pinto e Silva, Study director, University of Campinas (Unicamp)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395342
- Sponsor's protocol ID
- 08/2011/PC
- Status last verified
- Jul 2012
- First submitted
- 4 Jul 2011
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23997960
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development
- ClinicalTrials.gov ID
- NCT01395342
- Acronym / sponsor ID
- 08/2011/PC
- Keywords
- Pregnant women, Pre-eclampsia, Exercise, Hypertension, Pregnancy-Induced, Parturition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood pressure and heart rate data | No intervention | Other: Exercise using stationary bicycle |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant with 12 to 20 weeks gestational
- have chronic blood pressure, previous pre-eclampsia or both
- able to perform a exercise
Key exclusion criteria (7 listed)
- multiple pregnancy
- Systemic lupus erythematosus
- heart disease
- neurological disease
- renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise using stationary bicycleAlso: incidence of pre-eclampsia, types of birth, perinatal outcomes, blood pressureBefore 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 | blood pressure and heart rate data |
Primary outcome
Risk to development pre-eclampsia
Time frame: up to 28 weeks
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.
2 secondary outcomes
Types of birth
Time frame: up to 28 weeks
Perinatal outcomes
Time frame: up to 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
- Derived from this study: PubMed 23997960Kasawara 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.
Related trials for Pre-eclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João Luiz C Pinto e Silva study director
University of Campinas (Unicamp)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise using stationary bicycle in people with Pre-eclampsia and Hypertension, Pregnancy-Induced, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk to development pre-eclampsia (time frame: up to 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01395342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2012.