Clinical trial NCT05096078: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Keywords: Gestational diabetes
Circuit Exercise
Cognition
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Blood count test 1
timeFrame: 6 weeks after baseline
measure: Blood count test 2
timeFrame: 6 weeks after baseline
measure: Blood count test 3
timeFrame: 6 weeks after baseline
measure: Blood count test 4
timeFrame: 6 weeks after baseline
measure: Blood count test 5
timeFrame: 6 weeks after baseline
measure: Blood count test 6
timeFrame: 6 weeks after baseline
measure: Blood count test 7
timeFrame: 6 weeks after baseline
measure: Blood count test 8
timeFrame: 6 weeks after baseline
Secondary outcomes:
measure: Montreal Cognitive Assessment Scale
timeFrame: 6 weeks after baseline
measure: WMS Number Range Test
timeFrame: 6 weeks after baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
affiliation: Medipol University
name: Miray BUDAK, PhD
role: STUDY_DIRECTOR
affiliation: Medipol University
name: Saadet Turhan
role: PRINCIPAL_INVESTIGATOR
References: