The Effect of Circuit Exercise Program in Gestational Diabetes

Not Applicable

• Conditions: Gestational Diabetes

• Registration Number: NCT05096078
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-16
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-27
• Status Verified: 2022-03
• Primary Completion: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment Scale	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.
WMS Number Range Test	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.

Trial Locations

Locations (1)

Istanbul Medipol University; 🇹🇷 Istanbul, Beykoz, Turkey