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Structured Aerobic and Resistance Exercise and Gestational Diabetes

Primary Purpose

Gestational Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Structured Exercise
Sponsored by
Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus focused on measuring GDM, Exercise, Diabetes, Pregnancy

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Association for functional rehabilitation, recreation and applied kinesiology Impuls

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise and lifestyle change

Control

Arm Description

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.

Standard antenatal care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of macrosomic infants
Weight gain in pregnancy
Body mass and percentage of fat measured by caliper

Full Information

First Posted
July 19, 2014
Last Updated
July 16, 2016
Sponsor
Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse
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1. Study Identification

Unique Protocol Identification Number
NCT02196571
Brief Title
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
GDM, Exercise, Diabetes, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise and lifestyle change
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard antenatal care
Intervention Type
Other
Intervention Name(s)
Structured Exercise
Primary Outcome Measure Information:
Title
Number of pregnant women with complications during pregnancy, labour and delivery
Description
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
Time Frame
up to labour
Secondary Outcome Measure Information:
Title
Number of macrosomic infants
Time Frame
delivery
Title
Weight gain in pregnancy
Description
Body mass and percentage of fat measured by caliper
Time Frame
After recruitment and during pregnancy (30, 33 and 36 weeks)
Other Pre-specified Outcome Measures:
Title
Low Back Pain
Description
Visual analogue scale Roland-Morris Low Back Pain and Disability Questionnaire Pelvic Girdle Questionnaire
Time Frame
after recruitment and during pregnancy (30 and 36 weeks)
Title
Physical Activity in Pregnancy
Description
Pregnancy Physical Activity Questionnaire
Time Frame
After recruitment and in 30th and 36th week of pregnancy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iva Sklempe Kokic, PT, PgD Kin
Organizational Affiliation
Association for functional rehabilitation, recreation and applied kinesiology Impuls
Official's Role
Principal Investigator
Facility Information:
Facility Name
Association for functional rehabilitation, recreation and applied kinesiology Impuls
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

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Structured Aerobic and Resistance Exercise and Gestational Diabetes

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