Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00815828
Other study ID # 392/2006
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05081037 - Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS) N/A
Active, not recruiting NCT03249896 - Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes N/A
Terminated NCT03749889 - Low Carb vs Normal Carb in Pregnancy N/A
Completed NCT03859193 - Education Nutritional Video for Gestational Diabetics N/A
Recruiting NCT05037526 - Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes N/A
Completed NCT06178250 - Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester N/A
Not yet recruiting NCT06310356 - Continuous Glucose Monitoring for Women With Gestational Diabetes N/A
Not yet recruiting NCT06445530 - Nutrition Optimization and Community Upliftment for Postpartum Recovery N/A
Recruiting NCT02590016 - Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial Phase 4
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
Withdrawn NCT01947699 - Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide Phase 4
Recruiting NCT03008824 - Micronutrients in Pregnancy as a Risk Factor for Diabetes and Effects on Mother and Baby N/A
Active, not recruiting NCT01340924 - Relationship Between Gestational Diabetes and Type 2 Diabetes
Completed NCT00534105 - Lipid Metabolism in Gestational Diabetes N/A
Recruiting NCT00371306 - Comparison of Glucovance to Insulin for Diabetes During Pregnancy N/A
Completed NCT03388723 - Intergenerational Programming of Diabesity in Offspring of Women With Gestational Diabetes Mellitus
Recruiting NCT04521712 - Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia N/A
Enrolling by invitation NCT03307486 - Gestational Diabetes: a Cohort Study N/A
Active, not recruiting NCT03301792 - Group Versus Traditional Prenatal Care for Diabetes N/A
Enrolling by invitation NCT05603793 - YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition