The Effect of Circuit Exercise Program in Gestational Diabetes

March 29, 2022 updated by: Miray Budak, Istanbul Medipol University Hospital

The Effect of Circuit Exercise Program on Cognitive Function, Functional Exercise Capacity, Mobility, Depression and Quality of Life in Women With Gestational Diabetes

Gestational diabetes (GDM) is defined as 'pregnancy-onset or first noticed glucose intolerance'. The aim of this study is to investigate the effect of circuit exercise program applied in addition to diet therapy on cognitive function, functional exercise capacity, mobility, depression and quality of life in women with gestational diabetes. 60 female participants between the ages of 18-35 who meet the inclusion criteria will be included in the study. Participants will be randomly divided into 2 groups as diet group (n=30) and exercise group (n=30). All participants will receive GDM-specific dietary therapy for 6 weeks. In addition to diet therapy, individuals in the exercise group will be given a circuit exercise program for 6 weeks. Participants will be evaluated for blood values, cognitive status and functionality at the baseline and 6 weeks later.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Beykoz
      • Istanbul, Beykoz, Turkey, 34815
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • being diagnosed with gestational DM
  • being between the ages of 18-35
  • being in 24-32 weeks of pregnancy
  • being inactive physical activity level - (<300 MET weeks/day)

Exclusion Criteria:

  • Diagnosed with diabetes before pregnancy
  • have given birth before
  • Multiple Pregnancy (>2)
  • Intrauterine growth restriction
  • Preeclampsia
  • having high risk of preterm labor and on strict bed rest
  • treatment with insulin or oral hypoglycemic agents during pregnancy
  • Other significant severe or poorly controlled medical conditions (thyroid disease, cardio-respiratory disorders, ...)
  • taking medications that affect cognitive function, including corticosteroids, anti-depressants, or anti-epileptics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diet Group
Individuals will receive only dietary treatment that the dietitian deems appropriate for 6 weeks.
Other: Diet
Special diet program for gestational diabetes
Experimental: Exercise Group
In addition to the 6-week diet program that the dietitian deems appropriate, a circuit exercise program will be applied for 6 weeks. The circuit exercise program will consist of a medium-intensity circuit training for 50 minutes, 3 days a week, detailing the main muscle groups of the patients (chest, back, biceps, triceps, deltoid, quadriceps, thigh and calf muscles). Exercise intensity will be monitored using Borg's scale of perceived exertion, with a target intensity of 12 to 14. 8 exercises will be given in a continuous, circuit-type manner with short 1-minute rests.
Other: Diet
Special diet program for gestational diabetes
Other: Exercise
The circuit exercise program will consist of a medium-intensity circuit training for 50 minutes, 3 days a week, detailing the main muscle groups of the patients (chest, back, biceps, triceps, deltoid, quadriceps, thigh and calf muscles). Exercise intensity will be monitored using Borg's scale of perceived exertion, with a target intensity of 12 to 14. 8 exercises will be given in a continuous, circuit-type manner with short 1-minute rests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood count test 1
Time Frame: 6 weeks after baseline
Fasting blood glucose (FBG) value will be recorded.
6 weeks after baseline
Blood count test 2
Time Frame: 6 weeks after baseline
Postprandial blood glucose (PBG) value will be recorded.
6 weeks after baseline
Blood count test 3
Time Frame: 6 weeks after baseline
HbA1c value will be recorded.
6 weeks after baseline
Blood count test 4
Time Frame: 6 weeks after baseline
Total cholesterol (T-col) value will be recorded.
6 weeks after baseline
Blood count test 5
Time Frame: 6 weeks after baseline
High-density lipoprotein cholesterol (HDL) value will be recorded.
6 weeks after baseline
Blood count test 6
Time Frame: 6 weeks after baseline
Low-density lipoprotein cholesterol (LDL) value will be recorded.
6 weeks after baseline
Blood count test 7
Time Frame: 6 weeks after baseline
Insulin value will be recorded.
6 weeks after baseline
Blood count test 8
Time Frame: 6 weeks after baseline
Triglyceride (TG) value will be recorded.
6 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment Scale
Time Frame: 6 weeks after baseline
It is a screening scale developed to evaluate the early stages of cognitive impairment. Min score is 0, max score is 30. High scores mean a better outcome.
6 weeks after baseline
WMS Number Range Test
Time Frame: 6 weeks after baseline
In the forward number range, the patient is asked to repeat the numbers told to her in the same order, and in the backward number range, the patient is asked to repeat the said numbers from the end to the beginning. High scores mean a better outcome.
6 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: Saadet Turhan, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2020

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GestationalDM.Exer.Cog.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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