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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00815828
First received: December 30, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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 Intervention
Gestational Diabetes
Other: Resistance exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

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 [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To verify the impact of the exercise program on the adequacy of capillary glycemic control of the pregnant women [ Time Frame: weekly ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: October 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Group that don't do the resistance exercises
Other: Resistance exercises
Resistance exercises program consisting of 08 different exercises.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00815828

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

Publications:
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
Study First Received: December 30, 2008
Last Updated: December 30, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Gestational Diabetes
Resistance Exercise
Pregnancy
Insulin

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Pregnancy Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014