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

Primary Purpose

Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resistance exercises
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gestational Diabetes focused on measuring Gestational Diabetes, Resistance Exercise, Pregnancy, Insulin

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine from University of Sao Paulo

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Group that don't do the resistance exercises

Outcomes

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

Secondary Outcome Measures

To verify the impact of the exercise program on the adequacy of capillary glycemic control of the pregnant women

Full Information

First Posted
December 30, 2008
Last Updated
December 30, 2008
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00815828
Brief Title
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

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Gestational Diabetes, Resistance Exercise, Pregnancy, Insulin

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Group that don't do the resistance exercises
Intervention Type
Other
Intervention Name(s)
Resistance exercises
Intervention Description
Resistance exercises program consisting of 08 different exercises.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To verify the impact of the exercise program on the adequacy of capillary glycemic control of the pregnant women
Time Frame
weekly

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo C Barros, Physical Educator
Organizational Affiliation
Faculty of Medicine from University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine from University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
14749658
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.
Results Reference
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PubMed Identifier
10912903
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.
Results Reference
background
PubMed Identifier
15451933
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.
Results Reference
background
PubMed Identifier
7823386
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.
Results Reference
background
PubMed Identifier
12547738
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.
Results Reference
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The Effects of Resistance Exercises in Glycemic Control of Women With Gestational Diabetes

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