Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension

Study Overview
=================
Brief Summary
-----------------
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
-----------------
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

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

Conditions
-----------------
Pregnancy, Gestational Diabetes Mellitus, Chronic Hypertension in Obstetric Context

Intervention / Treatment
-----------------
* Other: Aerobic exercise
* Other: Stretch exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Weeks
Maximum Age: 27 Weeks

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic exercise<br>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<br>* 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<br>|
| Placebo Comparator: Stretch exercise<br>Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week | Other: Stretch exercise<br>* Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycated hemoglobin |  | day 1 and 10 weeks after training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA |  | day 1 and 10 weeks after training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycated hemoglobin, HOMA, Pregnancy, aerobic exercise