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Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension

Primary Purpose

Pregnancy, Gestational Diabetes Mellitus, Chronic Hypertension in Obstetric Context

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic exercise
Stretch exercise
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnancy focused on measuring Glycated hemoglobin, HOMA, Pregnancy, aerobic exercise

Eligibility Criteria

20 Weeks - 27 Weeks (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aerobic exercise

Stretch exercise

Arm Description

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

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

Outcomes

Primary Outcome Measures

glycated hemoglobin

Secondary Outcome Measures

HOMA

Full Information

First Posted
June 5, 2013
Last Updated
December 21, 2015
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT01885234
Brief Title
Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension
Official Title
Aerobic Training Effect in Pregnant Women With Gestational Diabetes and Chronic Hypertension: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Gestational Diabetes Mellitus, Chronic Hypertension in Obstetric Context
Keywords
Glycated hemoglobin, HOMA, Pregnancy, aerobic exercise

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
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
Arm Title
Stretch exercise
Arm Type
Placebo Comparator
Arm Description
Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
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
Intervention Name(s)
Stretch exercise
Intervention Description
Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week
Primary Outcome Measure Information:
Title
glycated hemoglobin
Time Frame
day 1 and 10 weeks after training
Secondary Outcome Measure Information:
Title
HOMA
Time Frame
day 1 and 10 weeks after training
Other Pre-specified Outcome Measures:
Title
First ventilatory threshold
Time Frame
day 1 and 10 weeks after training

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Weeks
Maximum Age & Unit of Time
27 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Geraldo L Ramos, MD
Organizational Affiliation
HC Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

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Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension

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