Ignite Creation Date:
2024-05-06 @ 3:04 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02196571
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2014-07-19
Brief Title:
Structured Aerobic and Resistance Exercise and Gestational Diabetes
Sponsor:
Association for Functional Rehabilitation Recreation and Applied Kinesiology Impulse
Organization:
Association for Functional Rehabilitation Recreation and Applied Kinesiology Impulse
Study Overview
Official Title:
The Impact of Structured Aerobic and Resistance Exercise on the Course and Outcome of Gestational Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None