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

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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

Study Description

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	Phase
Gestational Diabetes	Other: Resistance exercises	Not Applicable

Study Design


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
Actual Primary Completion Date :	November 2008
Actual Study Completion Date :	November 2008

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gestational diabetes

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

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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

Contacts and Locations

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

More Information

Publications:

Brankston GN, Mitchell BF, Ryan EA, Okun NB. Resistance exercise decreases the need for insulin in overweight women with gestational diabetes mellitus. Am J Obstet Gynecol. 2004 Jan;190(1):188-93.

Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60.

Sigal RJ, Kenny GP, Wasserman DH, Castaneda-Sceppa C. Physical activity/exercise and type 2 diabetes. Diabetes Care. 2004 Oct;27(10):2518-39. Review.

Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, Bouchard C, Buchner D, Ettinger W, Heath GW, King AC, et al. Physical activity and public health. A recommendation from the Centers for Disease Control and Prevention and the American College of Sports Medicine. JAMA. 1995 Feb 1;273(5):402-7. Review.

Artal R, O'Toole M. Guidelines of the American College of Obstetricians and Gynecologists for exercise during pregnancy and the postpartum period. Br J Sports Med. 2003 Feb;37(1):6-12; discussion 12.


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

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