Clinical Trial: Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes

Brief 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 Summary: 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 exerci
Sponsor: Professor Fernando Figueira Integral Medicine Institute

Current Primary Outcome: Change from Glycemic level [ Time Frame: Before and up to 5 minutes after the intervention ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change from Systolic and diastolic blood pressure [ Time Frame: Before and up to 5 minutes after the intervention ]
  Measured in mmHg every medical consultation
• Change from Heart rate (pulse) [ Time Frame: Before and up to 5 minutes after the intervention ]
  number of beats in 60 seconds
• Change from Respiratory rate [ Time Frame: Before and up to 5 minutes after the intervention ]
  number of movements indicative of inspiration and expiration per 60 seconds
• Change from Oxygen saturation [ Time Frame: Before and up to 5 minutes after the intervention ]
  Quantity oxygen is being transported in the blood at the time of measurement
• Change from Fetal heart rate [ Time Frame: Before and up to 5 minutes after the intervention ]
  Heartbeat frequency of the fetus per minute

Original Secondary Outcome: Same as current

Information By: Professor Fernando Figueira Integral Medicine Institute

Dates:
Date Received: September 28, 2016
Date Started: March 2016
Date Completion: November 2016
Last Updated: October 11, 2016
Last Verified: October 2016