Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes
Condition: Diabetes, Gestational
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      Gestational diabetes mellitus (GDM) is increasing worldwide and has been associated with
      adverse perinatal outcomes and high risk for chronic disease both for the mother and for the
      child. Physical exercise is feasible to diabetic pregnant women and contributes to a better
      glycemic control and to decrease adverse perinatal outcomes. However there are no studies
      assessing the effects of aquatic physical exercise on GDM control.
    

Detailed description: 
      The study will be conducted at Institute of Medicine Professor Fernando Figueira (IMIP),
      Brazil. The patients will be included in the study by consent after an explanation of the
      study goals. Women will be considered eligible for enrollment if they fulfill all the
      inclusion criteria and none of the exclusion criteria. Sample size was calculated with the
      aim of reducing glucose levels by 20% in intervention GDM group. A power of 80% and a level
      of significance of 5% was accepted and the calculated sample size in each arm was 30
      patients. Assuming a drop out of 20%, 72 pregnant women will be included in the study. 36
      gestational diabetics and and 36 normoglycemic pregnant women will develop an aquatic
      physical exercise in a thermal pool, 45 minutes per one time, from rehabilitation center of
      the IMIP. Before to practice the aquatic exercise women will have their physical capacity
      assessed by the Six minutes walk test and fetal conditions will be assessed by ultrasound.
      They will also be submitted to a dermatological examination by specialist. Primary endpoint
      will be glucose levels (glycemic test), secondary endpoints will be the following maternal
      and fetal: blood pressure, heart rate, respiratory rate, oxygen saturation level, fetal
      cardio beat and fetal movement.The variables will be measured before and after the water
      exercise session. Maternal and fetal characteristics of the study sample will be presented by
      group, intervention and control in terms of mean and standard deviation. For group
      comparisons of glucose levels and maternal and fetal variables, continuous and nominal data
      will be analyzed by t test for unpaired data and χ2 tests, respectively. Data will be
      analyzed using the intention-to-treat principle. Statistical analysis will be performed with
      the STATA version 12.0 and the level of significance will set to <0.05. Even in cases where
      there is the appearance of some criterion for discontinuation during the intervention
      (Aquatic physical exercise), the patient will be considered part of the group which was
      initially included in the randomization (intent to treat) and is not excluded from the study.
      The physical proprieties of water provide aquatic exercises as ideal for pregnant women. An
      aquatic physical exercise program developed with pregnant women in a thermal pool and under a
      physiotherapist supervision must ensure compliance. It is expected that this study provide
      evidences to the real role of aquatic physical exercise on glycemic control of GDM.
    

Intervention name(s): Aquatic exercise
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): Water aerobics; Hydrotherapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gestational Diabetes