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The Effects of Resistance Exercises in Glycemic Control of Women With Gestational Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00815828
Recruitment Status : Completed
First Posted : December 31, 2008
Last Update Posted : December 31, 2008
Sponsor:
Information provided by:
University of Sao Paulo

Brief Summary:
The object of this study is to evaluate patients with a diagnosis of GD who are included in a program of RE carried out with rubber tubes, comparing the frequency of women who will use insulin in the group who will participate in the program with the group that won't do the exercises, and to verify the impact of the program on the adequacy of capillary glycemic control of the pregnant women.

Condition or disease Intervention/treatment
Gestational Diabetes Other: Resistance exercises

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Resistance Exercises in Glycemic Control of Women With Gestational Diabetes - A Randomized Clinical Trial
Study Start Date : October 2006
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
1
Group that don't do the resistance exercises
Other: Resistance exercises
Resistance exercises program consisting of 08 different exercises.



Primary Outcome Measures :
  1. To compare the frequency of women who use insulin in the group who participate in the exercise program with the group that don't do the exercises [ Time Frame: weekly ]

Secondary Outcome Measures :
  1. To verify the impact of the exercise program on the adequacy of capillary glycemic control of the pregnant women [ Time Frame: weekly ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational diabetes diagnosis
  • Sedentary
  • Nonsmokers
  • Age between 18 and 45 years old
  • Pre-pregnancy BMI less than 35, without limiting physical factor for conducting exercises
  • With single pregnancy without fetal malformation:gestational age between 24 and 34 weeks, which have no other condition that contraindicate the conduct of exercises, with no risk factors for preterm delivery and who consent to participate in the study

Exclusion Criteria:

  • Patients who develop further clinical or obstetric complications that contraindicate the conducting exercises during pregnancy
  • Patients who start any form of physical activity after being randomized to the control group
  • Patients who start another form of physical activity than the resistance exercises after being randomized to the intervention group
  • Patients who were to use another product than insulin as a form of glycemic control
  • Patients to abandon the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815828


Locations
Brazil
Faculty of Medicine from University of Sao Paulo
Sao Paulo, Brazil, 05403900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Marcelo C Barros, Physical Educator Faculty of Medicine from University of Sao Paulo

Publications:
Responsible Party: Marcelo Costa de Barros, Faculty of Medicine from University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00815828     History of Changes
Other Study ID Numbers: 392/2006
First Posted: December 31, 2008    Key Record Dates
Last Update Posted: December 31, 2008
Last Verified: November 2008

Keywords provided by University of Sao Paulo:
Gestational Diabetes
Resistance Exercise
Pregnancy
Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications