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The Effect of Circuit Exercise Program in Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT05096078
Recruitment Status : Active, not recruiting
First Posted : October 27, 2021
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Miray Budak, Istanbul Medipol University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Other: Diet Other: Exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Blood count test 1 [ Time Frame: 6 weeks after baseline ]
    Fasting blood glucose (FBG) value will be recorded.

  2. Blood count test 2 [ Time Frame: 6 weeks after baseline ]
    Postprandial blood glucose (PBG) value will be recorded.

  3. Blood count test 3 [ Time Frame: 6 weeks after baseline ]
    HbA1c value will be recorded.

  4. Blood count test 4 [ Time Frame: 6 weeks after baseline ]
    Total cholesterol (T-col) value will be recorded.

  5. Blood count test 5 [ Time Frame: 6 weeks after baseline ]
    High-density lipoprotein cholesterol (HDL) value will be recorded.

  6. Blood count test 6 [ Time Frame: 6 weeks after baseline ]
    Low-density lipoprotein cholesterol (LDL) value will be recorded.

  7. Blood count test 7 [ Time Frame: 6 weeks after baseline ]
    Insulin value will be recorded.

  8. Blood count test 8 [ Time Frame: 6 weeks after baseline ]
    Triglyceride (TG) value will be recorded.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05096078


Locations
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Turkey
Istanbul Medipol University
Istanbul, Beykoz, Turkey, 34815
Sponsors and Collaborators
Istanbul Medipol University Hospital
Investigators
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Study Director: Miray BUDAK, PhD Medipol University
Principal Investigator: Saadet Turhan Medipol University
More Information
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Responsible Party: Miray Budak, Principal Investigator, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT05096078    
Other Study ID Numbers: GestationalDM.Exer.Cog.
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Miray Budak, Istanbul Medipol University Hospital:
Gestational diabetes
Circuit Exercise
Cognition
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications