Structured Aerobic and Resistance Exercise and Gestational Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus
• Intervention / Treatment: Other: Structured Exercise

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Association for functional rehabilitation, recreation and applied kinesiology Impuls

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise and lifestyle change; 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.	Other: Structured Exercise
No Intervention: Control; Standard antenatal care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)

Other Outcome Measures

Outcome Measure	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	Pregnancy Physical Activity Questionnaire	After recruitment and in 30th and 36th week of pregnancy

Collaborators and Investigators

• Sponsor: Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse
• Investigators: Principal Investigator: Iva Sklempe Kokic, PT, PgD Kin, Association for functional rehabilitation, recreation and applied kinesiology Impuls

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: July 19, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Estimate): July 19, 2016
• Last Update Submitted That Met QC Criteria: July 16, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Diabetes; Exercise; Pregnancy; GDM
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: Impuls001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No