Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01364506
Other study ID # upeclin/HC/FMB-Unesp-54
Secondary ID
Status Completed
Phase N/A
First received May 31, 2011
Last updated June 1, 2011
Start date January 2000
Est. completion date April 2001

Study information

Verified date May 2011
Source UPECLIN HC FM Botucatu Unesp
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date April 2001
Est. primary completion date April 2001
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 26 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Water aerobic exercise
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.

Locations

Country Name City State
Brazil Department of Gynecology and Obstetrics of Botucatu Medical School - São Paulo State University/UNESP Botucatu Sao Paulo

Sponsors (4)

Lead Sponsor Collaborator
UPECLIN HC FM Botucatu Unesp Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil, Federal University of São Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 39 weeks No
Secondary 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. 39 weeks No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Active, not recruiting NCT03903874 - Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt N/A
Recruiting NCT03662438 - HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT) N/A
Withdrawn NCT04540523 - Home-Based Exergaming Intervention N/A
Recruiting NCT03250000 - Changes in Microcirculation and Functional Status During Exacerbation of COPD N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT03430648 - Is Tau Protein Linked to Mobility Function?
Completed NCT05019482 - Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time N/A
Completed NCT03253406 - Health Wearables and College Student Health N/A
Not yet recruiting NCT05985460 - A Very Brief Intervention to Increase the Intention to Practice Physical Activity N/A
Completed NCT03380143 - Whole-of-Community Youth Population Physical Activity N/A
Completed NCT03700736 - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups N/A
Completed NCT03170921 - Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals N/A
Completed NCT04973813 - Active Choice Intervention About Physical Activity for Physically Inactive Adults N/A
Completed NCT03982095 - Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
Completed NCT03271112 - Frailty Prevention in Elders From Reunion Island N/A
Completed NCT05670223 - Healthy Activities Improve Lives N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Recruiting NCT04578067 - Empowering Immigrant Women for Active and Healthy Lifestyle N/A
Completed NCT03297567 - Physical Therapy Guidelines For Hospitalized Elderly N/A