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

Study Description

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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