NCT01723293

Brief Summary

The purpose of this study was to examine the behavior of the fetal heart rate in response to different intensities of acute maternal exercise in training and non-training pregnant women

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 14, 2014

Status Verified

August 1, 2012

Enrollment Period

3.2 years

First QC Date

November 5, 2012

Last Update Submit

November 13, 2014

Conditions

Keywords

Fetal heart rate, pregnancy, fetus, cardiovascular system

Outcome Measures

Primary Outcomes (1)

  • Fetal heart rate

    Fetal heart rate was measured before and after maternal walking exercise at 40 and 60% MaxHR

    Up to 34 weeks

Secondary Outcomes (2)

  • Fetal outcomes

    After labor

  • Maternal outcomes

    During labor

Study Arms (2)

Control

NO INTERVENTION

Sedentary pregnant women

Exercise group

EXPERIMENTAL
Behavioral: Exercise group

Interventions

Exercise groupBEHAVIORAL

The physical conditioning program included a total of three 55-60 minute sessions per week. Pregnant women started in 9-12 weeks and finished in 38-40 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate. Each session included a 25-minutes of aerobic exercise, 10-minutes of strength exercise and balance exercise as well, and 10-minutes of pelvic floor muscles training.

Exercise group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
  • Being able to communicate in spanish
  • Giving birth at Hospital Universitario de Fuenlabrada

You may not qualify if:

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not being regular in physical exercise program
  • Younger than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Politecnica de Madrid

Madrid, Madrid, 28040, Spain

RECRUITING

Study Officials

  • Rubén Barakat, PhD

    Universidad Politecnica de Madrid

    STUDY DIRECTOR

Central Study Contacts

Maria Perales, PhD student

CONTACT

Ruben Barakat, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 7, 2012

Study Start

March 1, 2010

Primary Completion

May 1, 2013

Study Completion

June 1, 2015

Last Updated

November 14, 2014

Record last verified: 2012-08

Locations