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Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension

NCT ID: NCT01885234

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Pregnancy Gestational Diabetes Mellitus Chronic Hypertension in Obstetric Context

Keywords

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Glycated hemoglobin HOMA Pregnancy aerobic exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type OTHER

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

Stretch exercise

Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week

Group Type PLACEBO_COMPARATOR

Stretch exercise

Intervention Type OTHER

Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week

Interventions

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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

Intervention Type OTHER

Stretch exercise

Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Weeks

Maximum Eligible Age

27 Weeks

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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José Geraldo L Ramos, MD

Role: PRINCIPAL_INVESTIGATOR

HC Porto Alegre

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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GDM-HAS120008

Identifier Type: -

Identifier Source: org_study_id