The Effect of Circuit Exercise Program in Gestational Diabetes

Gestational Diabetes Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05096078
• Other study ID #: GestationalDM.Exer.Cog.
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: June 2022

Study information

• Verified date: March 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• Diet
Special diet program for gestational diabetes
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul	Beykoz

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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