Effects of an Aquatic Physical Exercise Program on Glycemic Control and Perinatal Outcomes of Gestational Diabetes - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Glycemic control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •GDM diagnosis will be based on International Association of the Diabetes in Pregnancy Study Group (IADPSG), 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;
- •Aging 18 to 35 years;
- •Physically inactive (< 150' per week based on International Physical Activity Questionnaire.
排除标准
- •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;
研究组 & 干预措施
Control
Usual care of service Institute of Medicine Professor Fernando Figueira(IMIP) prenatal
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.
干预措施: Aquatic exercise (Other)
结局指标
主要结局
Glycemic control
时间窗: 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.
次要结局
- Prematurity(one year)
- Intra-uterus growth restriction (fetal ultrasound parameters)(one year)
- Newborns with macrosomia(one year)
- Weight gain in pregnancy(one year)
- Birth injury(one year)
- Cesarean section(one year)
- Systolic and diastolic blood pressure(one year)
- Maternal or neonatal intensive care admission(one year)
- Preeclampsia diagnosis(one year)
研究者
José Roberto da Silva Junior
Physiotherapist. Master in Maternal Health by Institute Medicine Professor Fernando Figueira. Professor of kinesiology at the College IBGM.
Professor Fernando Figueira Integral Medicine Institute