Blood PressureEXPREGNCT01383889
Acute Maternal and Fetal Effects of Exercise in Pregnancy
A study testing Physical exercise in people with Blood Pressure and Heart Rate and Rhythm Disorders, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
This will be an open randomized clinical trial involving pregnant women between 35 and 37 weeks randomized to two modalities of exercise: treadmill or stationary bike. The study hypothesis is that exercise on a stationary cycle causes less maternal and fetal effects in relation to treadmill exercise.We will study the… Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Heart Rate and Rhythm Disorders, Hypoglycemia
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2011to Dec 2012
- Phase
- Interventional
- 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 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single pregnancy
- Alive fetus
- Gestational age between 35 and 37 weeks
- Previous sedentarity
Who cannot join
- Smoking
- Chronic maternal illness
- Diseases that affect respiratory capacity
- Physical handicap precluding performing exercise
- Arterial Hypertension
- Diabetes in Pregnancy
Show all 14Show fewer
- Placenta praevia
- Preterm labor
- Bleeding in the third trimester
- Fetal Growth Restriction
- Oligo-hydramnios
- Brain-sparing effect
- Fetal malformations
- Medical contraindications for performing exercise
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Paraibano de Pesquisa Prof. Joaquim Amorim Neto
Campina Grande, Paraíba, 58406120
About this study
Official title: Acute Effects on the Mother and Fetus in Two Modalities of Exercise in Pregnancy: a Randomized Controlled Trial.
This will be an open randomized clinical trial involving pregnant women between 35 and 37 weeks randomized to two modalities of exercise: treadmill or stationary bike. The study hypothesis is that exercise on a stationary cycle causes less maternal and fetal effects in relation to treadmill exercise.We will study the acute effects of exercise for both the mother and the fetus, monitoring the parameters before, during and after exercise for 20 minutes. The exercise intensity will be moderate, remaining between 60% and 80% of maximum heart rate. Women will be monitored with a recording equipment of ABPM (ambulatory blood pressure monitorization) and continuous cardiotocography and blood will be collected to measure blood glucose, total cholesterol and HDL, nitrate and lactate before, during and after exercise. The analysis variables are: maternal heart rate and blood pressure, fetal heart rate, number of fetal movements, transient accelerations, decelerations, short-term variability, episodes of high variability, uterine tone, glucose, lactate, nitrate, total cholesterol and HDL.The analysis will be based on intention to treat, according to the recommendations of the CONSORT (2010).
Read the detailed description
Background: Exercise has been encouraged during pregnancy in order to reduce undesirable outcomes such as pre-eclampsia, excessive weight gain and diabetes. Despite widespread among pregnant women and obstetricians, little is known about the acute effects for both mother and fetus at the time of exercise, with most existing research controlling only the pre-and post-exercise.
Objective: To study the acute effects of two moderate modalities of exercise on the pregnant woman and fetus.
Methods: This will be an open randomized controlled trial to be conducted in Campina Grande, Brazil, from December 2011 to December 2012. The pregnant women with gestational age between 35 and 37 weeks will be randomized into two groups of moderate-intensity exercise: treadmill and stationary bicycle. Pregnant women and fetuses will be monitored for 60 minutes divided in three steps of 20 minutes each: baseline assessment, monitoring during exercise and recovery period. Women will be monitored using a recording equipment of ABPM (ambulatory blood pressure monitorization) and fetal heart rate will be monitored through computerized cardiotocography. Blood will be collected to measure blood glucose, total cholesterol and HDL, nitrate and lactate before, during and after exercise. The intensity of exercise will be maintained between 60% and 80% of maximum heart rate by Karvonen formula, in addition to the subjective perception of exertion on the modified Borg scale (moderate intensity). During the monitoring period (in the three moments mentioned above) blood will be collected for the measurement of glucose, total cholesterol and HDL, nitrate and lactate. The analysis variables are: maternal heart rate and blood pressure, fetal heart rate, number of fetal movements, transient accelerations, decelerations, short-term variability, episodes of high variability, uterine tone, glucose, lactate, nitrate, total cholesterol and HDL
Statistical Analysis: Statistical analysis will be performed using Epi Info 3.5.3 and Medcalc 11.6.6.0 or higher versions available at the time. The analysis will be based on intention to treat, according to the recommendations of the CONSORT (2010). For comparison of levels of glucose, lactate, cholesterol, nitrate, maternal blood pressure, maternal and fetal heart rate, fetal movements, transient accelerations, decelerations, changes in short-term episodes of high variation, and uterine tone in the two groups a parametric test will be used (Student's t) if these variables have normal distribution, otherwise they will be evaluated using the nonparametric test of Mann-Whitney. To determine the association between mode of exercise and frequency of fetal bradycardia the chi-square test of association (Pearson) will be used at a 5% significance level. The risk ratio (RR) will be calculated as a measure of relative risk, as well as its 95% confidence interval. If a significant difference in the rate of bradycardia will be demonstrated between the groups, the NNH (Number Need Harm) will be calculated.
Ethical issues: The research project was approved by Institutional Review Board under the number CAAE 0195.0.133.000-11 All the participants will be informed about the objectives of the research and only will be included if they agree voluntarily to participate and sign an informed consent term. There are no conflicts of interest.
- Conditions
- Blood Pressure, Heart Rate and Rhythm Disorders, Hypoglycemia, Lactate, Nitrate, Cholesterol (Total and HDL)
- Being tested
- Physical exercise
- Keywords
- Physical exercise, Pregnancy, Fetal well being
- Medical subject headings
- Hypoglycemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
Two modalities of exercise will be compared: treading mill and stationary bicycle. Pregnant women enrolled in the study will perform exercise during 20 minutes and will be monitored 20 minutes before, during and 20 minutes after exercise.
| Study group | Role | What they receive |
|---|---|---|
| Treading mill exercise | Other | Pregnant women in this group will perform treadmill exercise during 20 minutes. The intensity of exercise will be maintained between 60% and 80% of maximum heart rate by Karvonen formula, in addition to the subjective perception of exertion on the modified Borg scale (moderate intensity). Receives: Other: Physical exercise |
| Stationary bicycle exercise | Other | Pregnant women in this group will perform exercise using a stationary bicycle. The intensity of exercise will be maintained between 60% and 80% of maximum heart rate by Karvonen formula, in addition to the subjective perception of exertion on the modified Borg scale (moderate intensity). Receives: Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal bradycardia
Fetal heart rate will be monitored durante 60 minutes, 20 minutes before, 20 minutes during and 20 minutes after two modalities of exercise: treading mill and stationary bicycle. The frequency of fetal bradycardia will be assessed.
Measured: 60 minutes
Secondary outcomes (8)
Maternal blood pressure
Maternal blood pressure will be monitored during 60 minutes (20 minutes before, 20 minutes during and 20 minutes after the exercise)
Measured: 60 minutes
Maternal heart rate
Maternal heart rate will be monitored during 60 minutes (20 minutes before, 20 minutes during and 20 minutes after the exercise)
Measured: 60 minutes
Glycemia
Maternal glycemia will be monitored during 60 minutes (20 minutes before, 20 minutes during and 20 minutes after the exercise)
Measured: 60 minutes
Maternal lactate
Maternal heart rate will be monitored during 60 minutes (20 minutes before, 20 minutes during and 20 minutes after the exercise)
Measured: 60 minutes
Maternal nitrate
Maternal nitrate will be monitored during 60 minutes (20 minutes before, 20 minutes during and 20 minutes after the exercise)
Measured: 60 minutes
Total Cholesterol and HDL
Total Cholesterol and HDL will be monitored during 60 minutes (20 minutes before, 20 minutes during and 20 minutes after the exercise)
Measured: 60 minutes
Fetal heart rate
Fetal heart rate will be monitored during 60 minutes (20 minutes before, 20 minutes during and 20 minutes after the exercise). The following parameters will be assessed: fetal heart rate, bradycardia, fetal movements, transient accelerations, decelerations, changes in short-term episodes of high variation
Measured: 60 minutes
Uterine tone
Uterine tone will be assessed 20 minutes before, 20 minutes during and 20 minutes after exercise
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Collaborators
- Professor Fernando Figueira Integral Medicine Institute, Federal University of Paraíba
- Responsible party
- Principal investigator, Isabela Coutinho, Instituto Materno Infantil Prof. Fernando Figueira
- Investigators
- Melania MR Amorim, MD, PhD, Principal investigator, Instituto Materno Infantil Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383889
- Sponsor's protocol ID
- EXPREG 2011
- Acronym
- EXPREG
- Status last verified
- Mar 2013
- First submitted
- 27 Jun 2011
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects on the Mother and Fetus in Two Modalities of Exercise in Pregnancy: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01383889
- Acronym / sponsor ID
- EXPREG / EXPREG 2011
- Conditions
- Blood Pressure, Heart Rate and Rhythm Disorders, Hypoglycemia, Lactate, Nitrate, Cholesterol (Total and HDL)
- Keywords
- Physical exercise, Pregnancy, Fetal well being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Collaborators
- Professor Fernando Figueira Integral Medicine Institute, Federal University of Paraíba
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jun 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.
This will be an open randomized clinical trial involving pregnant women between 35 and 37 weeks randomized to two modalities of exercise: treadmill or stationary bike. The study hypothesis is that exercise on a stationary cycle causes less maternal and fetal effects in relation to treadmill exercise.We will study the acute effects of exercise for both the mother and the fetus, monitoring the parameters before, during and after exercise for 20 minutes. The exercise intensity will be moderate, remaining between 60% and 80% of maximum heart rate. Women will be monitored with a recording equipment of ABPM (ambulatory blood pressure monitorization) and continuous cardiotocography and blood will be collected to measure blood glucose, total cholesterol and HDL, nitrate and lactate before, during and after exercise. The analysis variables are: maternal heart rate and blood pressure, fetal heart rate, number of fetal movements, transient accelerations, decelerations, short-term variability, episodes of high variability, uterine tone, glucose, lactate, nitrate, total cholesterol and HDL.The analysis will be based on intention to treat, according to the recommendations of the CONSORT (2010).
Detailed description
Background: Exercise has been encouraged during pregnancy in order to reduce undesirable outcomes such as pre-eclampsia, excessive weight gain and diabetes. Despite widespread among pregnant women and obstetricians, little is known about the acute effects for both mother and fetus at the time of exercise, with most existing research controlling only the pre-and post-exercise.
Objective: To study the acute effects of two moderate modalities of exercise on the pregnant woman and fetus.
Methods: This will be an open randomized controlled trial to be conducted in Campina Grande, Brazil, from December 2011 to December 2012. The pregnant women with gestational age between 35 and 37 weeks will be randomized into two groups of moderate-intensity exercise: treadmill and stationary bicycle. Pregnant women and fetuses will be monitored for 60 minutes divided in three steps of 20 minutes each: baseline assessment, monitoring during exercise and recovery period. Women will be monitored using a recording equipment of ABPM (ambulatory blood pressure monitorization) and fetal heart rate will be monitored through computerized cardiotocography. Blood will be collected to measure blood glucose, total cholesterol and HDL, nitrate and lactate before, during and after exercise. The intensity of exercise will be maintained between 60% and 80% of maximum heart rate by Karvonen formula, in addition to the subjective perception of exertion on the modified Borg scale (moderate intensity). During the monitoring period (in the three moments mentioned above) blood will be collected for the measurement of glucose, total cholesterol and HDL, nitrate and lactate. The analysis variables are: maternal heart rate and blood pressure, fetal heart rate, number of fetal movements, transient accelerations, decelerations, short-term variability, episodes of high variability, uterine tone, glucose, lactate, nitrate, total cholesterol and HDL
Statistical Analysis: Statistical analysis will be performed using Epi Info 3.5.3 and Medcalc 11.6.6.0 or higher versions available at the time. The analysis will be based on intention to treat, according to the recommendations of the CONSORT (2010). For comparison of levels of glucose, lactate, cholesterol, nitrate, maternal blood pressure, maternal and fetal heart rate, fetal movements, transient accelerations, decelerations, changes in short-term episodes of high variation, and uterine tone in the two groups a parametric test will be used (Student's t) if these variables have normal distribution, otherwise they will be evaluated using the nonparametric test of Mann-Whitney. To determine the association between mode of exercise and frequency of fetal bradycardia the chi-square test of association (Pearson) will be used at a 5% significance level. The risk ratio (RR) will be calculated as a measure of relative risk, as well as its 95% confidence interval. If a significant difference in the rate of bradycardia will be demonstrated between the groups, the NNH (Number Need Harm) will be calculated.
Ethical issues: The research project was approved by Institutional Review Board under the number CAAE 0195.0.133.000-11 All the participants will be informed about the objectives of the research and only will be included if they agree voluntarily to participate and sign an informed consent term. There are no conflicts of interest.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treading mill exercise | Other | Other: Physical exercisePregnant women in this group will perform treadmill exercise during 20 minutes. The intensity of exercise will be maintained between 60% and 80% of maximum heart rate by Karvonen formula, in addition to the subjective perception of exertion on the modified Borg scale (moderate intensity). |
| Stationary bicycle exercise | Other | Other: Physical exercisePregnant women in this group will perform exercise using a stationary bicycle. The intensity of exercise will be maintained between 60% and 80% of maximum heart rate by Karvonen formula, in addition to the subjective perception of exertion on the modified Borg scale (moderate intensity). |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Single pregnancy
- Alive fetus
- Gestational age between 35 and 37 weeks
- Previous sedentarity
Key exclusion criteria (14 listed)
- Smoking
- Chronic maternal illness
- Diseases that affect respiratory capacity
- Physical handicap precluding performing exercise
- Arterial Hypertension
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 |
|---|---|---|
| Physical exerciseTwo modalities of exercise will be compared: treading mill and stationary bicycle. Pregnant women enrolled in the study will perform exercise during 20 minutes and will be monitored 20 minutes before, during and 20 minutes after exercise. | Other | Stationary bicycle exercise, Treading mill exercise |
Primary outcome
Fetal bradycardia
Time frame: 60 minutes
Fetal heart rate will be monitored durante 60 minutes, 20 minutes before, 20 minutes during and 20 minutes after two modalities of exercise: treading mill and stationary bicycle. The frequency of fetal bradycardia will be assessed.
8 secondary outcomes
Maternal blood pressure
Time frame: 60 minutes
Maternal heart rate
Time frame: 60 minutes
Glycemia
Time frame: 60 minutes
Maternal lactate
Time frame: 60 minutes
Maternal nitrate
Time frame: 60 minutes
Total Cholesterol and HDL
Time frame: 60 minutes
Fetal heart rate
Time frame: 60 minutes
Uterine tone
Time frame: 60 minutes
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 5 Mar 2013.
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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.
Melania MR Amorim, MD, PhD principal investigator
Instituto Materno Infantil Prof. Fernando Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Blood Pressure and Heart Rate and Rhythm Disorders, run by Instituto Materno Infantil Prof. Fernando Figueira 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 4 inclusion and 14 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 5 Mar 2013. 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.
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?
Fetal bradycardia (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2013.