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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 30, 2008 | ||||
| Last Updated Date | December 30, 2008 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effects of Resistance Exercises in Glycemic Control of Women With Gestational Diabetes | ||||
| Official Title ICMJE | The Effects of Resistance Exercises in Glycemic Control of Women With Gestational Diabetes - A Randomized Clinical Trial | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Gestational Diabetes | ||||
| Intervention ICMJE | Other: Resistance exercises
Resistance exercises program consisting of 08 different exercises. |
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| Study Arm (s) | 1
Group that don't do the resistance exercises
Intervention: Other: Resistance exercises |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 64 | ||||
| Completion Date | November 2008 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00815828 | ||||
| Other Study ID Numbers ICMJE | 392/2006 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Marcelo Costa de Barros, Faculty of Medicine from University of Sao Paulo | ||||
| Study Sponsor ICMJE | University of Sao Paulo | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Sao Paulo | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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