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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and lifestyle change | Experimental | 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. |
|
| Control | No Intervention | Standard antenatal care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Exercise | Other |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Low Back Pain | Visual analogue scale Roland-Morris Low Back Pain and Disability Questionnaire Pelvic Girdle Questionnaire | after recruitment and during pregnancy (30 and 36 weeks) |
| Physical Activity in Pregnancy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iva Sklempe Kokic, PT, PgD Kin | Association for functional rehabilitation, recreation and applied kinesiology Impuls | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Association for functional rehabilitation, recreation and applied kinesiology Impuls | Zagreb | 10000 | Croatia |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D009043 | Motor Activity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
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Pregnancy Physical Activity Questionnaire
| After recruitment and in 30th and 36th week of pregnancy |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |