Effects of an Aquatic Physical Exercise Program on Glycaemic Control and Perinatal Outcomes of Gestational Diabetes: Study Protocol for a Randomized Controlled Trial
Condition: Diabetes, Gestational
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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 randomized
      controlled trials (RCT) assessing the effects of aquatic physical exercise on GDM control and
      adverse maternal and fetal outcomes.

      A RCT will be conducted at Institute of Medicine Professor Fernando Figueira (IMIP), Brazil.
      IMIP is a reference hospital in the Northeast Brazil for mother and child care and performed
      about 6,000 deliveries per year. The recruitment of patients will focus on GDM women
      diagnosed at IMIP that referred to this center for treatment. Obstetrical staff will identify
      pregnant women recently diagnosed with GDM. These patients will be approached by a member of
      the study team and ask permission to be forwarded after an explanation of the study goals.
      GDM women will be considered eligible for enrollment if they fulfill all the inclusion
      criteria and none of the exclusion criteria. Interested patients will be invited to sign a
      written informed consent.

      Sample size was calculated with the aim of reducing glucose levels by 20% in intervention
      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 will develop an aquatic physical exercise
      program in a thermal pool, three times per week during two months, and 36 gestational
      diabetics will receive usual care from IMIP.

      To ensure that similar guidelines for GDM clinical treatment are maintained for the two
      groups, IMIP obstetrical staff will undertake the ongoing GDM management of all trial
      participants for the period of the study. Participants are usually clinically evaluated at
      minimum every two weeks depending on GDM control, according to the IMIP guidelines for GDM. A
      capillary glucose test is performed in each clinical visit. It will be analyzed the mean
      capillary glucose profile after intervention (minimum of five determinations per woman).
      Insulin or oral hypoglycemic required will be compared among the two groups.

      All pregnant women will wear a pedometer (Yamax Digi Walker SW-200, Tokyo, Japan) during the
      whole study. Pedometer readings will provide a measure of physical activity to compare both
      groups. All diabetics pregnant women will be recorded of their clinical history and undertake
      a cardiologic evaluation.

      Randomization will be done according to a computed-generated allocation (www.randomized.com).
      Pregnant women will be assigned, in a 1:1 ratio, to exercise intervention or usual care.
      Blinding of the study to the randomization arm is not possible due to the nature of
      intervention.

      Primary endpoint will be glucose levels control (glicemy test) and use of insulin (use or not
      insulin), secondary endpoints will be the following maternal and fetal outcomes: weight gain
      during pregnancy, blood pressure, preeclampsia diagnosis, intra-uterus growth restriction,
      preterm birth, Cesarean section, macrosomia and maternal or neonatal intensive care
      admission. The information will be acquired through the medical records of patients.

      Maternal and fetal characteristics of the study sample will be presented by group,
      intervention and control in terms of mean and SD. For group comparisons of glucose levels and
      perinatal 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 3.1 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. In order to evaluate the criteria for discontinuation of study will be established
      a Committee on External Monitoring (CME).

      The physical proprieties of water provide aquatic exercises as ideal for pregnant women. An
      aquatic physical exercise program developed with GDM 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 GDM control.
    

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: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes, Gestational; Pregnancy Outcome; Exercise; glycemic control