Pregnancy RelatedNCT01364506
The Effects of Aerobic Water Exercise on Pregnancy
A study testing Water aerobic exercise in people with Pregnancy Related and Physical Activity, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
Objective: To assess the relationship between maternal cardiovascular capacity and aerobic water exercise during the gestational periods of hemodynamic overload. Study design: randomized clinical trial, with 41 healthy pregnant women assigned to one of two groups: Control and Water exercise. Read more about this study
- Who is it for?
- Ages 15 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Physical Activity
- What is being tested?
- Water aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2000to Apr 2001
- 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 15 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Low-risk (healthy) pregnant women
- At 16-20 weeks of gestation
- Seen at the Prenatal Care Service for Low-risk Pregnancies of Botucatu Medical School-UNESP
Who cannot join
- Twin pregnancy
- Clinical or obstetric disorder contraindicating an exercise program
- Withdrawal from prenatal care at our service
- Loss to follow-up; and failure to attend three (or more) exercise sessions, which was considered non-compliance to the aerobic water exercise program
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Gynecology and Obstetrics of Botucatu Medical School - São Paulo State University/UNESP
Botucatu, São Paulo
About this study
Official title: Randomized Clinical Study of the Effects of Aerobic Water Exercise on Maternal Cardiovascular Adaptation to Pregnancy
Objective: To assess the relationship between maternal cardiovascular capacity and aerobic water exercise during the gestational periods of hemodynamic overload. Study design: randomized clinical trial, with 41 healthy pregnant women assigned to one of two groups: Control and Water exercise. Maternal cardiovascular capacity (maximum oxygen consumption, cardiac output, stroke volume, heart rate and mean arterial pressure), physical performance (relative HR, treadmill speed and self-perceived exertion) and neonatal outcome (gestational age, weight, Apgar index and length of infant's hospitalization) were assessed. Means were evaluated by dependent and independent t-tests, and proportions by the chi-square method (p<0.05). Results: The control variables showed that the groups were homogeneous. Water exercise was associated with maintenance of VO2max, increase in stroke volume and cardiac output, and better performance on stress tests in the third trimester of gestation. No significant difference in neonatal variables was observed. Conclusion: Water exercise maintained cardiovascular capacity and performance under submaximal stress, and did not affect hemodynamic adaptation to gestation or neonatal outcome.
Read the detailed description
INTRODUCTION
Significant hemodynamic changes take place during the short period of pregnancy, very often placing a major burden on the maternal cardiovascular system. Normal pregnancy is characterized by an increase in cardiac output (CO), stroke volume (SV), heart rate (HR) and blood volume, and decrease in arterial pressure and vascular resistance. Classic studies have demonstrated an increase of up to 50% in maternal CO during the second and third trimesters. These circulatory adaptations are responsible for supplying nutrients and oxygen to the placenta and the fetus.
The physiological changes that follow regular exercise improve training efficiency and performance, defining the concept of adaptation to exercise or aerobic training. Exercise causes the heart and lungs to be more efficient by increasing cardiovascular capacity or resistance. CO, SV and maximum oxygen consumption (VO2max) increase while HR and AP decrease. The importance of these effects on overall health has been recognized by the most outstanding medical and scientific groups. Therefore, regular exercise has been widely promoted and a large number of women decide to begin or continue to exercise during pregnancy.
This change in women's behavior has become a matter of concern among obstetricians and has important practical implications - is the maternal body apt to bear the hemodynamic burden of pregnancy in association with exercise stress? Studies on the effects of exercise on pregnancy are scarce and show conflicting results, probably due to differences in exercise frequency, intensity, type, duration, and gestational age at training initiation.
Aiming at standardizing exercise practice and thus promote materno-fetal health, the American College of Obstetricians and Gynecologists (ACOG) issued, in 1985, guidelines for exercise during pregnancy. In subsequent reviews, new recommendations were added, and water exercise during pregnancy was recommended.
Water exercise offers some particular benefits that include the maintenance of body temperature, control of gestational edema, and increase in diuresis. Moreover, it can be easily performed up to the end of pregnancy, which favors compliance. These advantages added to the fact that it has no adverse effect on the fetus explain the preference for this kind of exercise during pregnancy.
Considering the lack of scientific evidence of the effects of exercise during pregnancy, and the results obtained in our previous work, the purpose of this study was to assess the relationship of aerobic water exercise during the gestational periods of greater hemodynamic burden with maternal cardiovascular capacity and neonatal outcomes.
METHODS
This study is part of a project approved by the Committee of Research Ethics of the Botucatu Medical School-UNESP on May 10, 1999.
Study design: randomized clinical, without intention to treat. Study subjects: All the eligible women who volunteered to participate were sequentially enrolled and randomized to one of two groups according to a computer-generated randomization list of numbers created with Epi-Info software. Each sequential number corresponded to a sealed opaque envelope containing the information on the randomization group in order to ensure concealment. Group 1 consisted of 29 women engaged in Water Exercise, and group 2 included 31 pregnant women not participating in the program (control). Variables: the independent variable studied was the practice of water exercise. The control variables, which were assessed at baseline, included age, parity, pre-gestational body mass index (BMI), HR and MAP, smoking, sedentarism, and gestational age at baseline and at stress testing. The dependent variables regarding cardiovascular capacity and physical performance at the submaximal stress test were VO2max; SV; CO; HR and MAP, relative HR treadmill speed and scores obtained with the scale of Borg. Neonatal variables included gestational age, weight; Apgar index at minute 1 and at minute 5, and length (days) of infant's hospitalization.
Assessment of cardiovascular capacity: performed during prenatal visits at 16-20, 28-33 and 34-39 weeks. Cardiovascular capacity was evaluated by using a treadmill submaximal stress test, according to the protocol of Balke-Ware \& Bruce that requires five minutes on treadmill at fixed incline and constant individualized speed with AP and HR monitoring. Assessment of physical performance at stress testing - for this purpose, relative HR, treadmill speed and the Borg scale scores, obtained during testing, were used. A specific questionnaire was administered to all subjects in order to quantify stress perception during testing.
Data processing and analyses - given that the aim of this study was to assess the efficacy (exploratory and not intention-to-treat) of water exercise during pregnancy, our analysis included only the subjects who underwent cardiovascular assessment at the three study moments and missed no more than 2 exercise sessions/month. These data were stored in a specific database Statistical analysis was performed with SPSS software version 10.0.7. Means were compared using ANOVA followed by t-tests for independent (between groups) and dependent (within groups) samples. Data were adequately transformed when necessary. Proportions were compared by the chi-square test (X2). Statistical significance was set at 5% (p<0.005).
- Conditions
- Pregnancy Related, Physical Activity
- Being tested
- Water aerobic exercise
- Keywords
- Cardiovascular capacity, Water exercise, Hydrokinetic Therapy, Pregnancy, Perinatal outcomes
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water aerobic exerciseOther
The hydrotherapy program of Prevedel et al.14 was used. One-hour sessions, led by a physiotherapist under the supervision of an obstetrician, were held three times a week in an indoor swimming-pool heated at 28oC-32oC, and consisted of exercises of moderate intensity (60-70% of maximum heart rate). Subgroups of up to 10 subjects participated in each session. Sessions were offered at different times of the day (morning, afternoon, and evening).
The exercises included 5 phases: stretching, warm up, endurance training, strength training and relaxation with breathing exercises, in accordance with the recommendations of ACOG11.
| Study group | Role | What they receive |
|---|---|---|
| Water exercise | Experimental | Not described Receives: Other: Water aerobic exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular capacity
Performed during prenatal visits at 16-20, 28-33 and 34-39 weeks. Cardiovascular capacity was evaluated by using a treadmill submaximal stress test, according to the protocol of Balke-Ware \& Bruce that requires five minutes on treadmill at fixed incline and constant individualized speed with AP and HR monitoring.
Measured: 39 weeks
Secondary outcomes (1)
Assessment of physical performance at stress testing; stress perception during testing
Relative HR, treadmill speed and the Borg scale scores, obtained during testing, were used. A specific questionnaire was administered to all subjects in order to quantify stress perception during testing.
Measured: 39 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJan 2000
- Primary completionApr 2001
- Study completionApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Federal University of São Paulo, Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
- Investigators
- Iracema MP Calderon, MD, Phd, Study director, Department of Gynecology and Obstetrics of Botucatu Medical School - São Paulo State University/UNESP. Botucatu, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364506
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-54
- Status last verified
- May 2011
- First submitted
- 31 May 2011
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study of the Effects of Aerobic Water Exercise on Maternal Cardiovascular Adaptation to Pregnancy
- ClinicalTrials.gov ID
- NCT01364506
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-54
- Conditions
- Pregnancy Related, Physical Activity
- Keywords
- Cardiovascular capacity, Water exercise, Hydrokinetic Therapy, Pregnancy, Perinatal outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Federal University of São Paulo, Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
- Study start
- Jan 2000
- Primary completion
- Apr 2001 (actual)
- Study completion
- Apr 2001 (actual)
- First posted
- 2 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.
Objective: To assess the relationship between maternal cardiovascular capacity and aerobic water exercise during the gestational periods of hemodynamic overload. Study design: randomized clinical trial, with 41 healthy pregnant women assigned to one of two groups: Control and Water exercise. Maternal cardiovascular capacity (maximum oxygen consumption, cardiac output, stroke volume, heart rate and mean arterial pressure), physical performance (relative HR, treadmill speed and self-perceived exertion) and neonatal outcome (gestational age, weight, Apgar index and length of infant's hospitalization) were assessed. Means were evaluated by dependent and independent t-tests, and proportions by the chi-square method (p<0.05). Results: The control variables showed that the groups were homogeneous. Water exercise was associated with maintenance of VO2max, increase in stroke volume and cardiac output, and better performance on stress tests in the third trimester of gestation. No significant difference in neonatal variables was observed. Conclusion: Water exercise maintained cardiovascular capacity and performance under submaximal stress, and did not affect hemodynamic adaptation to gestation or neonatal outcome.
Detailed description
INTRODUCTION
Significant hemodynamic changes take place during the short period of pregnancy, very often placing a major burden on the maternal cardiovascular system. Normal pregnancy is characterized by an increase in cardiac output (CO), stroke volume (SV), heart rate (HR) and blood volume, and decrease in arterial pressure and vascular resistance. Classic studies have demonstrated an increase of up to 50% in maternal CO during the second and third trimesters. These circulatory adaptations are responsible for supplying nutrients and oxygen to the placenta and the fetus.
The physiological changes that follow regular exercise improve training efficiency and performance, defining the concept of adaptation to exercise or aerobic training. Exercise causes the heart and lungs to be more efficient by increasing cardiovascular capacity or resistance. CO, SV and maximum oxygen consumption (VO2max) increase while HR and AP decrease. The importance of these effects on overall health has been recognized by the most outstanding medical and scientific groups. Therefore, regular exercise has been widely promoted and a large number of women decide to begin or continue to exercise during pregnancy.
This change in women's behavior has become a matter of concern among obstetricians and has important practical implications - is the maternal body apt to bear the hemodynamic burden of pregnancy in association with exercise stress? Studies on the effects of exercise on pregnancy are scarce and show conflicting results, probably due to differences in exercise frequency, intensity, type, duration, and gestational age at training initiation.
Aiming at standardizing exercise practice and thus promote materno-fetal health, the American College of Obstetricians and Gynecologists (ACOG) issued, in 1985, guidelines for exercise during pregnancy. In subsequent reviews, new recommendations were added, and water exercise during pregnancy was recommended.
Water exercise offers some particular benefits that include the maintenance of body temperature, control of gestational edema, and increase in diuresis. Moreover, it can be easily performed up to the end of pregnancy, which favors compliance. These advantages added to the fact that it has no adverse effect on the fetus explain the preference for this kind of exercise during pregnancy.
Considering the lack of scientific evidence of the effects of exercise during pregnancy, and the results obtained in our previous work, the purpose of this study was to assess the relationship of aerobic water exercise during the gestational periods of greater hemodynamic burden with maternal cardiovascular capacity and neonatal outcomes.
METHODS
This study is part of a project approved by the Committee of Research Ethics of the Botucatu Medical School-UNESP on May 10, 1999.
Study design: randomized clinical, without intention to treat. Study subjects: All the eligible women who volunteered to participate were sequentially enrolled and randomized to one of two groups according to a computer-generated randomization list of numbers created with Epi-Info software. Each sequential number corresponded to a sealed opaque envelope containing the information on the randomization group in order to ensure concealment. Group 1 consisted of 29 women engaged in Water Exercise, and group 2 included 31 pregnant women not participating in the program (control). Variables: the independent variable studied was the practice of water exercise. The control variables, which were assessed at baseline, included age, parity, pre-gestational body mass index (BMI), HR and MAP, smoking, sedentarism, and gestational age at baseline and at stress testing. The dependent variables regarding cardiovascular capacity and physical performance at the submaximal stress test were VO2max; SV; CO; HR and MAP, relative HR treadmill speed and scores obtained with the scale of Borg. Neonatal variables included gestational age, weight; Apgar index at minute 1 and at minute 5, and length (days) of infant's hospitalization.
Assessment of cardiovascular capacity: performed during prenatal visits at 16-20, 28-33 and 34-39 weeks. Cardiovascular capacity was evaluated by using a treadmill submaximal stress test, according to the protocol of Balke-Ware \& Bruce that requires five minutes on treadmill at fixed incline and constant individualized speed with AP and HR monitoring. Assessment of physical performance at stress testing - for this purpose, relative HR, treadmill speed and the Borg scale scores, obtained during testing, were used. A specific questionnaire was administered to all subjects in order to quantify stress perception during testing.
Data processing and analyses - given that the aim of this study was to assess the efficacy (exploratory and not intention-to-treat) of water exercise during pregnancy, our analysis included only the subjects who underwent cardiovascular assessment at the three study moments and missed no more than 2 exercise sessions/month. These data were stored in a specific database Statistical analysis was performed with SPSS software version 10.0.7. Means were compared using ANOVA followed by t-tests for independent (between groups) and dependent (within groups) samples. Data were adequately transformed when necessary. Proportions were compared by the chi-square test (X2). Statistical significance was set at 5% (p<0.005).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water exercise | Experimental | Other: Water aerobic exercise |
| Control | No intervention | – |
Who may qualify
- Ages
- 15 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Low-risk (healthy) pregnant women
- At 16-20 weeks of gestation
- Seen at the Prenatal Care Service for Low-risk Pregnancies of Botucatu Medical School-UNESP
Key exclusion criteria (4 listed)
- Twin pregnancy
- Clinical or obstetric disorder contraindicating an exercise program
- Withdrawal from prenatal care at our service
- Loss to follow-up; and failure to attend three (or more) exercise sessions, which was considered non-compliance to the aerobic water exercise program
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 |
|---|---|---|
| Water aerobic exerciseThe hydrotherapy program of Prevedel et al.14 was used. One-hour sessions, led by a physiotherapist under the supervision of an obstetrician, were held three times a week in an indoor swimming-pool heated at 28oC-32oC, and consisted of exercises of moderate intensity (60-70% of maximum heart rate). Subgroups of up to 10 subjects participated in each session. Sessions were offered at different times of the day (morning, afternoon, and evening). The exercises included 5 phases: stretching, warm up, endurance training, strength training and relaxation with breathing exercises, in accordance with the recommendations of ACOG11. | Other | Water exercise |
Primary outcome
Cardiovascular capacity
Time frame: 39 weeks
Performed during prenatal visits at 16-20, 28-33 and 34-39 weeks. Cardiovascular capacity was evaluated by using a treadmill submaximal stress test, according to the protocol of Balke-Ware \& Bruce that requires five minutes on treadmill at fixed incline and constant individualized speed with AP and HR monitoring.
1 secondary outcome
Assessment of physical performance at stress testing; stress perception during testing
Time frame: 39 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 2 Jun 2011.
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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.
Iracema MP Calderon, MD, Phd study director
Department of Gynecology and Obstetrics of Botucatu Medical School - São Paulo State University/UNESP. Botucatu, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water aerobic exercise in people with Pregnancy Related and Physical Activity, run by UPECLIN HC FM Botucatu Unesp 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 4 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 2 Jun 2011. 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?
Cardiovascular capacity (time frame: 39 weeks). 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 2 Jun 2011.