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Completed

NCT Number: NCT01885234

Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension

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.

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Key information

Conditions

Pregnancy Chronic Hypertension in Obstetric Context Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

20 week–27 week

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

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

Other

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

Primary outcomes

  1. glycated hemoglobin

    Time frame: day 1 and 10 weeks after training

Secondary outcomes

  1. HOMA

    Time frame: day 1 and 10 weeks after training

Other outcomes

  1. First ventilatory threshold

    Time frame: day 1 and 10 weeks after training

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2013
Registry last updated
Dec 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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