Clinical trial NCT02196571: Structured Aerobic and Resistance Exercise and Gestational Diabetes
Official title: The Impact of Structured Aerobic and Resistance Exercise on the Course and Outcome of Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: GDM
Exercise
Diabetes
Pregnancy
Lead sponsor: Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 42
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of pregnant women with complications during pregnancy, labour and delivery
timeFrame: up to labour
Secondary outcomes:
measure: Number of macrosomic infants
timeFrame: delivery
measure: Weight gain in pregnancy
timeFrame: After recruitment and during pregnancy (30, 33 and 36 weeks)
Other outcomes:
measure: Low Back Pain
timeFrame: after recruitment and during pregnancy (30 and 36 weeks)
measure: Physical Activity in Pregnancy
timeFrame: After recruitment and in 30th and 36th week of pregnancy
Locations:
city: Zagreb
country: Croatia
facility: Association for functional rehabilitation, recreation and applied kinesiology Impuls
Study officials:
affiliation: Association for functional rehabilitation, recreation and applied kinesiology Impuls
name: Iva Sklempe Kokic, PT, PgD Kin
role: PRINCIPAL_INVESTIGATOR
References: