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The Effect of Circuit Exercise Program in Gestational Diabetes

Primary Purpose

Gestational Diabetes

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Diet
Exercise
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring Gestational diabetes, Circuit Exercise, Cognition

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diet Group

Exercise Group

Arm Description

Individuals will receive only dietary treatment that the dietitian deems appropriate for 6 weeks.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Montreal Cognitive Assessment Scale
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.
WMS Number Range Test
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.

Full Information

First Posted
October 15, 2021
Last Updated
March 29, 2022
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05096078
Brief Title
The Effect of Circuit Exercise Program in Gestational Diabetes
Official Title
The Effect of Circuit Exercise Program on Cognitive Function, Functional Exercise Capacity, Mobility, Depression and Quality of Life in Women With Gestational Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Gestational diabetes, Circuit Exercise, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diet Group
Arm Type
Active Comparator
Arm Description
Individuals will receive only dietary treatment that the dietitian deems appropriate for 6 weeks.
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
Special diet program for gestational diabetes
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood count test 1
Description
Fasting blood glucose (FBG) value will be recorded.
Time Frame
6 weeks after baseline
Title
Blood count test 2
Description
Postprandial blood glucose (PBG) value will be recorded.
Time Frame
6 weeks after baseline
Title
Blood count test 3
Description
HbA1c value will be recorded.
Time Frame
6 weeks after baseline
Title
Blood count test 4
Description
Total cholesterol (T-col) value will be recorded.
Time Frame
6 weeks after baseline
Title
Blood count test 5
Description
High-density lipoprotein cholesterol (HDL) value will be recorded.
Time Frame
6 weeks after baseline
Title
Blood count test 6
Description
Low-density lipoprotein cholesterol (LDL) value will be recorded.
Time Frame
6 weeks after baseline
Title
Blood count test 7
Description
Insulin value will be recorded.
Time Frame
6 weeks after baseline
Title
Blood count test 8
Description
Triglyceride (TG) value will be recorded.
Time Frame
6 weeks after baseline
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment Scale
Description
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.
Time Frame
6 weeks after baseline
Title
WMS Number Range Test
Description
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.
Time Frame
6 weeks after baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miray BUDAK, PhD
Organizational Affiliation
Medipol University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Saadet Turhan
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34815
Country
Turkey

12. IPD Sharing Statement

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The Effect of Circuit Exercise Program in Gestational Diabetes

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