Effects of an Aquatic Physical Exercise Program on Glycaemic Control and Perinatal Outcomes of Gestational Diabetes: Study Protocol for a Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT01940003|
Recruitment Status : Recruiting
First Posted : September 11, 2013
Last Update Posted : October 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes, Gestational||Other: Aquatic exercise||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of an Aquatic Physical Exercise Program on Glycemic Control and Perinatal Outcomes of Gestational Diabetes - a Randomized Clinical Trial|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
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.
- Glycemic control [ Time Frame: one year ]
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.
- Intra-uterus growth restriction (fetal ultrasound parameters) [ Time Frame: one year ]
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 ]Preterm birth (before 37th gestational week).
- Newborns with macrosomia [ Time Frame: one year ]Cesarean section Birth injury Macrosomia (birth weight > 4,000g). Nominal variable, dichotomous yes or no.
- Weight gain in pregnancy [ Time Frame: one year ]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 ]Nominal variable, dichotomous yes or no.
- Systolic and diastolic blood pressure [ Time Frame: one year ]Measured in mmHg every medical consultation
- Preeclampsia diagnosis [ Time Frame: one year ]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 ]Nominal variable, dichotomous yes or no.
- Birth injury [ Time Frame: one year ]Be will considered any kind of injury of the newborn occurred during delivery. Nominal variable, dichotomous yes or no.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940003
|Contact: José Roberto da Silva Junior, Masteremail@example.com|
|Contact: João Guilherme Bezerra Alves, Doctoratefirstname.lastname@example.org|
|Instituto de Medicina Integral Prof. Fernando Figueira||Recruiting|
|Recife, Pernambuco, Brazil, 50070-550|
|Contact: José Roberto da Silva Junior, Master 55-81-9815-4243 email@example.com|
|Sub-Investigator: Karine Ferreira Agra, Master|
|Principal Investigator: José Roberto da Silva Junior, Master|
|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|