Trial record 4 of 204 for:    "Diabetes, Gestational"

Effects of an Aquatic Physical Exercise Program on Glycaemic Control and Perinatal Outcomes of Gestational Diabetes: Study Protocol for a Randomized Controlled Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Professor Fernando Figueira Integral Medicine Institute
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco
Information provided by (Responsible Party):
José Roberto da Silva Junior, Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov Identifier:
NCT01940003
First received: August 23, 2013
Last updated: October 17, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to verify the efficacy of an aquatic physical exercise program on GDM control and adverse maternal and fetal outcomes.


Condition Intervention
Diabetes, Gestational
Other: Aquatic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of an Aquatic Physical Exercise Program on Glycemic Control and Perinatal Outcomes of Gestational Diabetes - a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Professor Fernando Figueira Integral Medicine Institute:

Primary Outcome Measures:
  • Glycemic control [ Time Frame: one year ] [ Designated as safety issue: No ]

    Blood glucose test: maternal glucose levels on third trimester of pregnancy and use of insulin

    Use of insulin: need to use or not of insulin to control gestational diabetes mellitus. Variable nominal dichotomous yes / no.



Secondary Outcome Measures:
  • Intra-uterus growth restriction (fetal ultrasound parameters) [ Time Frame: one year ] [ Designated as safety issue: No ]

    Intra-uterus growth restriction diagnosis will based on the following findings:

    birthweight percentile < 10 for gestational age, morphological ultrasound with Doppler (assessment of umbilical blood flow).


  • Prematurity [ Time Frame: one year ] [ Designated as safety issue: No ]
    Preterm birth (before 37th gestational week).

  • Newborns with macrosomia [ Time Frame: one year ] [ Designated as safety issue: No ]
    Cesarean section Birth injury Macrosomia (birth weight > 4,000g). Nominal variable, dichotomous yes or no.

  • Weight gain in pregnancy [ Time Frame: one year ] [ Designated as safety issue: No ]
    Weight measured at the end of pregnancy minus pre-pregnancy weight informed by pregnant woman (cm)

  • Maternal or neonatal intensive care admission [ Time Frame: one year ] [ Designated as safety issue: No ]
    Nominal variable, dichotomous yes or no.

  • Systolic and diastolic blood pressure [ Time Frame: one year ] [ Designated as safety issue: No ]
    Measured in mmHg every medical consultation

  • Preeclampsia diagnosis [ Time Frame: one year ] [ Designated as safety issue: No ]
    blood hypertension (levels of systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHglevels of systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg) associated with proteinuria

  • Cesarean section [ Time Frame: one year ] [ Designated as safety issue: No ]
    Nominal variable, dichotomous yes or no.

  • Birth injury [ Time Frame: one year ] [ Designated as safety issue: No ]
    Be will considered any kind of injury of the newborn occurred during delivery. Nominal variable, dichotomous yes or no.


Estimated Enrollment: 72
Study Start Date: September 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Usual care of service Institute of Medicine Professor Fernando Figueira(IMIP) prenatal
Experimental: Aquatic exercise
Pool-based exercise classes will be completed in groups of 4 to 6 participants under the instruction of a physiotherapist. The exercise program will be conducted three times per week and each session lasting 45 minute. This will be conducted since GDM diagnosis (26-28th gestational week) to the end of the third trimester (38-39th gestational week). Thus, an average of 30 training sessions will be planned for each pregnant woman.
Other: Aquatic exercise
The aquatic exercise program will be under the professional guidance of a physiotherapist, with water at a temperature of around 26 to 28°C. The exercise sessions will be executed following the steps: 1) Heating (stretching and flexibility, static method, during 5'); 2) Aerobic exercise (running, displacements and combined movements of arms and legs, with 1minute interval, to 1minute activity and of during 20') 3) Spot exercises (strength / endurance of the upper and lower limbs and abdomen, using the resistance of water for 15') 4) Relaxation (slow walks for 5'). During the sessions of exercises the pregnant women will have heart rate monitored by the frequency meter (Polar Electro OY) to control the intensity of the exercises that will focus on the range of moderate intensity.
Other Names:
  • Water aerobics
  • Hydrotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GDM diagnosis will be based on International Association of the Diabetes in Pregnancy Study Group (IADPSG), Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study (2 h 75 g oral glucose tolerance test (OGTT): a fasting glucose ≥ 92 mg/dl or a one hour result of ≥ 80 mg/dl, or a two hour result of ≥ 153 mg/dl;
  • Aging 18 to 35 years;
  • Physically inactive (< 150` per week based on International Physical Activity Questionnaire.

Exclusion Criteria:

  • Kidney disease or collagenosis;
  • Previous history of gestational diabetes;
  • Diabetes type 1 or type 2;
  • Hypertensive disorders related to pregnancy;
  • Hemodynamic instability;
  • Obstetric labor;
  • Vaginal bleeding;
  • Cognitive disorder, auditory, visual or motor severely limiting, attested by a medical specialist;
  • Skin disorders who have a contraindication to the use of a swimming pool;
  • Urinary tract infection;
  • Be inserted in the program of regular exercise;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940003

Contacts
Contact: José Roberto da Silva Junior, Master 55-81-9815-4243 roberto.junior@imip.org.br
Contact: João Guilherme Bezerra Alves, Doctorate 99746351 joaoguilherme@imip.org.br

Locations
Brazil
Instituto de Medicina Integral Prof. Fernando Figueira Recruiting
Recife, Pernambuco, Brazil, 50070-550
Contact: José Roberto da Silva Junior, Master    55-81-9815-4243    roberto.junior@imip.org.br   
Sub-Investigator: Karine Ferreira Agra, Master         
Principal Investigator: José Roberto da Silva Junior, Master         
Sponsors and Collaborators
Professor Fernando Figueira Integral Medicine Institute
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco
Investigators
Principal Investigator: José Roberto da Silva Junior, Master Institute of Medicine Professor Fernando Figueira
Study Director: João Guilherme Bezerra Alves, doctorate Institute of Medicine Professor Fernando Figueira
Study Chair: Paulo Sergio Gomes Nogueira Borges, Master Institute of Medicine Professor Fernando Figueira
Study Chair: Karine Ferreira Agra, Master Institute of Medicine Professor Fernando Figueira
Study Chair: Isabelle Eunice de Albuquerque Pontes, Master Institute of Medicine Professor Fernando Figueira
  More Information

Additional Information:
No publications provided by Professor Fernando Figueira Integral Medicine Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: José Roberto da Silva Junior, Physiotherapist. Master in Maternal Health by Institute Medicine Professor Fernando Figueira. Professor of kinesiology at the College IBGM., Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov Identifier: NCT01940003     History of Changes
Other Study ID Numbers: U1111-1147-1141
Study First Received: August 23, 2013
Last Updated: October 17, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Professor Fernando Figueira Integral Medicine Institute:
Diabetes, Gestational
Pregnancy Outcome
Exercise
glycemic control

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

ClinicalTrials.gov processed this record on September 18, 2014