The Effects of Resistance Exercises in Glycemic Control o... | NCT00815828

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

NCT00815828

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Dec 31, 2008Estimated

Enrollment

64Actual

Phase

Not Applicable

Conditions

Gestational Diabetes

Interventions

Resistance exercises

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Dec 30, 2008

First Submission Date that Met QC Criteria

Dec 30, 2008

First Posted Date

Dec 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2008

Last Update Posted Date

Dec 31, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Group that don't do the resistance exercises	Other: Resistance exercises

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resistance exercises	Other	Resistance exercises program consisting of 08 different exercises.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
To verify the impact of the exercise program on the adequacy of capillary glycemic control of the pregnant women		weekly

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcelo C Barros, Physical Educator	Faculty of Medicine from University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine from University of Sao Paulo		São Paulo	São Paulo	05403900	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14749658	Background	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.
10912903	Background	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.

ID	Term
D016640	Diabetes, Gestational
D007333	Insulin Resistance

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus