Structured Aerobic and Resistance Exercise and Gestational Diabetes

Gestational Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196571
• Other study ID #: Impuls001
• Status: Completed
• Phase: N/A
• First received: July 19, 2014
• Last updated: July 16, 2016
• Start date: July 2014
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Croatian Council of Physiotherapists
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Other:
• Structured Exercise

Locations

Country	Name	City	State
Croatia	Association for functional rehabilitation, recreation and applied kinesiology Impuls	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Other	Physical Activity in Pregnancy	Pregnancy Physical Activity Questionnaire	After recruitment and in 30th and 36th week of pregnancy	No
Primary	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	No
Secondary	Number of macrosomic infants		delivery	No
Secondary	Weight gain in pregnancy	Body mass and percentage of fat measured by caliper	After recruitment and during pregnancy (30, 33 and 36 weeks)	No