Ignite Creation Date:
2024-05-05 @ 11:34 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01364506
Status:
COMPLETED
Last Update Posted:
2011-06-02
First Post:
2011-05-31
Brief Title:
The Effects of Aerobic Water Exercise on Pregnancy
Sponsor:
UPECLIN HC FM Botucatu Unesp
Organization:
UPECLIN HC FM Botucatu Unesp
Study Overview
Official Title:
Randomized Clinical Study of the Effects of Aerobic Water Exercise on Maternal Cardiovascular Adaptation to Pregnancy
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 infants hospitalization were assessed Means were evaluated by dependent and independent t-tests and proportions by the chi-square method p005 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 womens 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 infants 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 sessionsmonth These data were stored in a specific database Statistical analysis was performed with SPSS software version 1007 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 p0005
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 womens 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 infants 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 sessionsmonth These data were stored in a specific database Statistical analysis was performed with SPSS software version 1007 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 p0005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None