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

Gestational Diabetes Clinical Trial

Official title:

The Effects of Resistance Exercises in Glycemic Control of Women With Gestational Diabetes - A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815828
• Other study ID #: 392/2006
• Status: Completed
• Phase: N/A
• First received: December 30, 2008
• Last updated: December 30, 2008
• Start date: October 2006
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• Resistance exercises
Resistance exercises program consisting of 08 different exercises.

Locations

Country	Name	City	State
Brazil	Faculty of Medicine from University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		weekly	No
Secondary	To verify the impact of the exercise program on the adequacy of capillary glycemic control of the pregnant women		weekly	No