Clinical trial NCT02931656: Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes
Official title: Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Gestational
Keywords: Gestational Diabetes
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Ciência e Tecnologia de Pernambuco
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2016-10-13
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* GDM Group: GDM diagnosis will be based on International Association of the Diabetes in Pregnancy Study Group (IADPSG) and WHO, 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;
* Control Group: Normal glucose tolerance (IADPSG /WHO)
* 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;

Primary outcomes:
measure: Change from Glycemic level
timeFrame: Before and up to 5 minutes after the intervention
Secondary outcomes:
measure: Change from Systolic and diastolic blood pressure
timeFrame: Before and up to 5 minutes after the intervention
measure: Change from Heart rate (pulse)
timeFrame: Before and up to 5 minutes after the intervention
measure: Change from Respiratory rate
timeFrame: Before and up to 5 minutes after the intervention
measure: Change from Oxygen saturation
timeFrame: Before and up to 5 minutes after the intervention
measure: Change from Fetal heart rate
timeFrame: Before and up to 5 minutes after the intervention
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: José Roberto da Silva Junior
state: Pernambuco
Study officials:
affiliation: Institute of Integrative Medicine Professor Fernando Figueira
name: João Guilherme Bezerra Alves/, Doctor
role: STUDY_DIRECTOR
affiliation: Institute of Integrative Medicine Professor Fernando Figueira
name: Alex Sandro Rolland de Souza, Doctor
role: STUDY_CHAIR
References: