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NCT Number: NCT02196571

Structured Aerobic and Resistance Exercise and Gestational Diabetes

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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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Association for functional rehabilitation, recreation and applied kinesiology Impuls

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Exercise

Other

Primary outcomes

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

    Time frame: 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 outcomes

  1. Number of macrosomic infants

    Time frame: delivery

  2. Weight gain in pregnancy

    Time frame: After recruitment and during pregnancy (30, 33 and 36 weeks)

    Body mass and percentage of fat measured by caliper

Other outcomes

  1. Low Back Pain

    Time frame: after recruitment and during pregnancy (30 and 36 weeks)

    Visual analogue scale Roland-Morris Low Back Pain and Disability Questionnaire Pelvic Girdle Questionnaire

  2. Physical Activity in Pregnancy

    Time frame: After recruitment and in 30th and 36th week of pregnancy

    Pregnancy Physical Activity Questionnaire

Sponsors and collaborators

Lead sponsor

Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 22, 2014
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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