Gestational Diabetes Mellitus
Conditions
Keywords
GDM, Exercise, Diabetes, Pregnancy
Brief summary
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.
Interventions
OTHERStructured Exercise
Sponsors
Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of pregnant women with complications during pregnancy, labour and delivery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of macrosomic infants | delivery | — |
| Weight gain in pregnancy | After recruitment and during pregnancy (30, 33 and 36 weeks) | Body mass and percentage of fat measured by caliper |
Other
| Measure | Time frame | Description |
|---|---|---|
| Low Back Pain | after recruitment and during pregnancy (30 and 36 weeks) | Visual analogue scale Roland-Morris Low Back Pain and Disability Questionnaire Pelvic Girdle Questionnaire |
| Physical Activity in Pregnancy | After recruitment and in 30th and 36th week of pregnancy | Pregnancy Physical Activity Questionnaire |
Countries
Croatia
Outcome results
None listed