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The Effects of Aerobic Water Exercise on Pregnancy

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Federal University of São Paulo
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01364506
First received: May 31, 2011
Last updated: June 1, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Pregnancy Related
Physical Activity
 Other: Water aerobic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Clinical Study of the Effects of Aerobic Water Exercise on Maternal Cardiovascular Adaptation to Pregnancy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • Cardiovascular capacity [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Assessment of physical performance at stress testing; stress perception during testing [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 41
Study Start Date: January 2000
Study Completion Date: April 2001
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Water exercise 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.
No Intervention: Control

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  Eligibility

Ages Eligible for Study:   15 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364506

Locations
Brazil
Department of Gynecology and Obstetrics of Botucatu Medical School - São Paulo State University/UNESP
Botucatu, Sao Paulo, Brazil
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Fundação de Amparo à Pesquisa do Estado de São Paulo
Federal University of São Paulo
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Investigators
Study Director: Iracema MP Calderon, MD, Phd Department of Gynecology and Obstetrics of Botucatu Medical School - São Paulo State University/UNESP. Botucatu, Brazil
  More Information

No publications provided

Responsible Party: Iracema de Mattos Paranhos Calderon, Department of Gynecology and Obstetrics of Botucatu Medical School - São Paulo State University/UNESP. Botucatu, Brazil
ClinicalTrials.gov Identifier: NCT01364506     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-54
Study First Received: May 31, 2011
Last Updated: June 1, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
Cardiovascular capacity
Water exercise
Hydrokinetic Therapy
Pregnancy
Perinatal outcomes

ClinicalTrials.gov processed this record on June 18, 2013