NCT01364506

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
Last Updated

June 2, 2011

Status Verified

May 1, 2011

Enrollment Period

1.2 years

First QC Date

May 31, 2011

Last Update Submit

June 1, 2011

Conditions

Keywords

Cardiovascular capacityWater exerciseHydrokinetic TherapyPregnancyPerinatal outcomes

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Assessment of physical performance at stress testing; stress perception during testing

    39 weeks

Study Arms (2)

Water exercise

EXPERIMENTAL
Other: Water aerobic exercise

Control

NO INTERVENTION

Interventions

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.

Water exercise

Eligibility Criteria

Age15 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynecology and Obstetrics of Botucatu Medical School - São Paulo State University/UNESP

Botucatu, São Paulo, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Iracema MP Calderon, MD, Phd

    Department of Gynecology and Obstetrics of Botucatu Medical School - São Paulo State University/UNESP. Botucatu, Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

January 1, 2000

Primary Completion

April 1, 2001

Study Completion

April 1, 2001

Last Updated

June 2, 2011

Record last verified: 2011-05

Locations