The Effects of Resistance Exercises in Glycemic Control of Women With Gestational Diabetes
This study has been completed.
Sponsor:
University of Sao Paulo
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
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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
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 Mellitus Diabetes, Gestational Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pregnancy Complications |
ClinicalTrials.gov processed this record on May 19, 2013