The Effect of Circuit Exercise Program on Cognitive Function, Functional Exercise Capacity, Mobility, Depression and Quality of Life in Women With Gestational Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Blood count test 7
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Blood count test 7
时间窗: 6 weeks after baseline
Insulin value will be recorded.
Blood count test 1
时间窗: 6 weeks after baseline
Fasting blood glucose (FBG) value will be recorded.
Blood count test 2
时间窗: 6 weeks after baseline
Postprandial blood glucose (PBG) value will be recorded.
Blood count test 3
时间窗: 6 weeks after baseline
HbA1c value will be recorded.
Blood count test 4
时间窗: 6 weeks after baseline
Total cholesterol (T-col) value will be recorded.
Blood count test 5
时间窗: 6 weeks after baseline
High-density lipoprotein cholesterol (HDL) value will be recorded.
Blood count test 6
时间窗: 6 weeks after baseline
Low-density lipoprotein cholesterol (LDL) value will be recorded.
Blood count test 8
时间窗: 6 weeks after baseline
Triglyceride (TG) value will be recorded.
次要结局
- Montreal Cognitive Assessment Scale(6 weeks after baseline)
- WMS Number Range Test(6 weeks after baseline)
研究者
Miray Budak
Principal Investigator
Istanbul Medipol University Hospital