NCT00815828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2008

Completed
Last Updated

December 31, 2008

Status Verified

November 1, 2008

Enrollment Period

2.1 years

First QC Date

December 30, 2008

Last Update Submit

December 30, 2008

Conditions

Keywords

Gestational DiabetesResistance ExercisePregnancyInsulin

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

    weekly

Study Arms (1)

1

OTHER

Group that don't do the resistance exercises

Other: Resistance exercises

Interventions

Resistance exercises program consisting of 08 different exercises.

1

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine from University of Sao Paulo

São Paulo, São Paulo, 05403900, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 14749658BACKGROUND
  • 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.

    PMID: 10912903BACKGROUND
  • 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.

    PMID: 15451933BACKGROUND
  • 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.

    PMID: 7823386BACKGROUND
  • 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.

    PMID: 12547738BACKGROUND

MeSH Terms

Conditions

Diabetes, GestationalInsulin Resistance

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Marcelo C Barros, Physical Educator

    Faculty of Medicine from University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 30, 2008

First Posted

December 31, 2008

Study Start

October 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 31, 2008

Record last verified: 2008-11

Locations