Structured Aerobic and Resistance Exercise and Gestational Diabetes

Study Overview
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Brief Summary
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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.

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

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Other: Structured Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: established diagnosis of gestational diabetes, age between 20 and 40, otherwise healthy pregnancy Exclusion Criteria: pharmacological treatment with oral hypoglicemics and/or insulin therapy introduced prior to trial enrollment, existing comorbidities and contraindications for exercise

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and lifestyle change<br>Women in the experimental group will be included in structured exercise programme two times per week with duration of 50 minutes.Participants will start with training sessions right after they are diagnosed with GDM and they will exercise until the end of the pregnancy or occurence of contraindications. Programme will consist of aerobic exercises (20 minutes), resistance exercises (20 minutes), plevic floor, stretching and relaxation exercises (10 minutes). Women in control group will receive standard antenatal care. | Other: Structured Exercise<br> <br> |
| No Intervention: Control<br>Standard antenatal care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pregnant women with complications during pregnancy, labour and delivery | 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 | up to labour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of macrosomic infants |  | delivery | 
| Weight gain in pregnancy | Body mass and percentage of fat measured by caliper | After recruitment and during pregnancy (30, 33 and 36 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GDM, Exercise, Diabetes, Pregnancy