Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885234
• Other study ID #: GDM-HAS120008
• Status: Completed
• Phase: N/A
• First received: June 5, 2013
• Last updated: December 21, 2015
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à PesquisaBrazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Weeks to 27 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Hypertension in Obstetric Context
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Hypertension
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	First ventilatory threshold		day 1 and 10 weeks after training	Yes
Primary	glycated hemoglobin		day 1 and 10 weeks after training	Yes
Secondary	HOMA		day 1 and 10 weeks after training	Yes