Structured Aerobic and Resistance Exercise and Gestational Diabetes

NCT02196571 | Completed

• 1 other identifier: Impuls001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus

Keywords

GDM; Exercise; Diabetes; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of macrosomic infants

  delivery

• Weight gain in pregnancy

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

Other Outcomes (2)

• Low Back Pain

  after recruitment and during pregnancy (30 and 36 weeks)

• Physical Activity in Pregnancy

  After recruitment and in 30th and 36th week of pregnancy

Study Arms (2)

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.

Other: Structured Exercise

Control

NO INTERVENTION

Standard antenatal care

Interventions

Structured Exercise OTHER

Exercise and lifestyle change

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• established diagnosis of gestational diabetes,
• age between 20 and 40,
• otherwise healthy pregnancy

You may not qualify if:

• pharmacological treatment with oral hypoglicemics and/or insulin therapy introduced prior to trial enrollment,
• existing comorbidities and
• contraindications for exercise

Sponsors & Collaborators

• Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse: lead

Study Sites (1)

Association for functional rehabilitation, recreation and applied kinesiology Impuls

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Diabetes, Gestational; Motor Activity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Iva Sklempe Kokic, PT, PgD Kin

  Association for functional rehabilitation, recreation and applied kinesiology Impuls

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PgD Kin

Study Record Dates

• First Submitted: July 19, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2016
• Last Updated: July 19, 2016

Record last verified: 2016-07

Locations

CR (1)