Clinical trial NCT00815828: The Effects of Resistance Exercises in Glycemic Control of Women With Gestational Diabetes
Official title: The Effects of Resistance Exercises in Glycemic Control of Women With Gestational Diabetes - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: Gestational Diabetes
Resistance Exercise
Pregnancy
Insulin
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-12-31
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: weekly
Secondary outcomes:
measure: To verify the impact of the exercise program on the adequacy of capillary glycemic control of the pregnant women
timeFrame: weekly
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Faculty of Medicine from University of Sao Paulo
Study officials:
affiliation: Faculty of Medicine from University of Sao Paulo
name: Marcelo C Barros, Physical Educator
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0002-9378(03)00951-7.
citation: 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. doi: 10.1097/00005768-200007000-00024.
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. doi: 10.2337/diacare.27.10.2518. No abstract available.
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. doi: 10.1001/jama.273.5.402.
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. doi: 10.1136/bjsm.37.1.6. No abstract available.