Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension

December 21, 2015 updated by: Hospital de Clinicas de Porto Alegre

Aerobic Training Effect in Pregnant Women With Gestational Diabetes and Chronic Hypertension: Randomized Clinical Trial

The aim of the present study is verify glycated hemoglobin (HbA1c) and HOMA behavior in pregnant women with gestational diabetes or chronic hypertension after an aerobic training in cycle-ergometer. The sample is composed by 64 pregnant and sedentary women, 20 weeks' pregnant.

Two experimental groups (gestational diabetes and chronic hypertension, n = 16 each) will perform a low-intensity aerobic training in cycle-ergometer, three times/week, for 45 minutes each session. Two control groups (gestational diabetes and chronic hypertension, n = 16 each) will perform an unique session/week of relaxation and stretching.

Outcomes: first ventilatory threshold, HbA1c,HOMA, type of delivery, weight and height of the newborn.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The statistical analysis will consist of:

  • descriptive statistic;
  • Levene's test
  • Shapiro Wilk's normality test
  • Parametric or non-parametric test
  • a=0.05
  • SPSS 17.0

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age > 20 years;
  • gestational age between 20 and 27 weeks (date of the last period and confirmed by ultrasound);
  • Only one foetus in the womb;
  • Without orthopedic limitations;
  • Non-smoker;
  • Medical clearance for exercise

Exclusion Criteria:

  • Pre-eclampsia;
  • fetal malformations;
  • Intrauterine fetal death

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic exercise
Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of aerobic exercise in a bicycle, 3 times a week
Other: Aerobic exercise
Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of aerobic exercise in a bicycle, 3 times a week
Placebo Comparator: Stretch exercise
Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week
Other: Stretch exercise
Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glycated hemoglobin
Time Frame: day 1 and 10 weeks after training
day 1 and 10 weeks after training

Secondary Outcome Measures

Outcome Measure
Time Frame
HOMA
Time Frame: day 1 and 10 weeks after training
day 1 and 10 weeks after training

Other Outcome Measures

Outcome Measure
Time Frame
First ventilatory threshold
Time Frame: day 1 and 10 weeks after training
day 1 and 10 weeks after training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: José Geraldo L Ramos, MD, HC Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDM-HAS120008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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