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临床试验/NCT02196571
NCT02196571已完成不适用

The Impact of Structured Aerobic and Resistance Exercise on the Course and Outcome of Gestational Diabetes Mellitus

Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Number of pregnant women with complications during pregnancy, labour and delivery

研究概览

简要总结

Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance of various degrees first manifested during pregnancy. The primary aim of treating GDM is to optimize glycaemic control and improve pregnancy outcomes. Also, as part of treatment, it is recommended to continue or initiate exercising with moderate intensity. However, available data on the effects of physical activity on GDM are based on a small number of trials. The aim of the trial is to examine and add new scientific evidence on possible health-related effects of application of structured programme consisting of aerobic and resistance exercises on the course and outcomes of GDM. Primary goal of research is to determine how proposed exercise programme effects glycaemic control, rate of complications during pregnancy, labour, delivery, immediate after delivery and health status of newborn. Main hypothesis is that parameters of glycaemic control, course of GDM, complications during delivery and birth outcomes directly and significantly correlate with participation in structured programme of exercise. Research will be conducted as experimentally designed randomized controlled trial. Participants will be pregnant women diagnosed with GDM, age between 20 and 40, without comorbidities. Women in the experimental group will be included in exercise programme two times per week with duration of 50 minutes. Training sessions will start right after the diagnosis and will be performed until the end of the pregnancy. The training protocol will follow international guidelines (ACOG, 2001; ACOG, 2002; ADA, 2008; NICE, 2008; ADA 2011). Women in the control group will receive standard medical care.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • established diagnosis of gestational diabetes,
  • age between 20 and 40,
  • otherwise healthy pregnancy

排除标准

  • pharmacological treatment with oral hypoglicemics and/or insulin therapy introduced prior to trial enrollment,
  • existing comorbidities and
  • contraindications for exercise

结局指标

主要结局

Number of pregnant women with complications during pregnancy, labour and delivery

时间窗: up to labour

Blood glucose levels, need for insulin and oral hypoglycemic drugs, need for cesarean section and other operative delivery methods, other adverse occurences during pregnancy, labour and delivery

次要结局

  • Weight gain in pregnancy(After recruitment and during pregnancy (30, 33 and 36 weeks))
  • Number of macrosomic infants(delivery)

研究者

发起方
Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse
申办方类型
Other
责任方
Principal Investigator
主要研究者

Iva Sklempe Kokic

PT, PgD Kin

Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse

研究点 (2)

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