Effect of a Supervised Exercise Program During Whole Pregnancy on Outcomes and Level of Depression. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change from level of depression at the end of the pregnancy
研究概览
简要总结
Due to physical and physiological changes that occur in pregnant women, depression is very common during this period. Recent research findings indicate that antenatal maternal mood state impacts on babies health. Nowadays, many researchers are focussed on examining the effects of physical exercise on foetal and maternal outcomes.
The main aim of this study was to assess the effectiveness of a supervised exercise program consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvis floor muscles training, on the prevention and treatment of depression in pregnant women. Additionally, the other purpose of the study was to analyze the effects of depression and physical exercise on outcomes.
Hypothesis: Pregnant women who do regular exercise during their pregnancies would have a better mood state than pregnant women who are sedentary, without having any negative effect on outcomes.
详细描述
BACKROUND: Recent studies have estimated the prevalence of depression during pregnancy at between 10% and 30%. This state can produce negative effects on the fetus as:
- Affect cerebral development
- Increase the risk of preterm birth and low birth weight
- Increase the risk of childhood overweight problems
- Adverse impact on the cognitive, emotional, social, and behavioural development of infants
Due to the possible side effect of antidepressants on mother and fetus, its necessary to examine alternative solutions to this state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- •Being able to communicate in spanish
- •Giving birth at Hospital Universitario de Fuenlabrada
排除标准
- •Multiparity
- •Obstetrician complications
- •Being interested in the study after 18 weeks
- •Not being regular in physical exercise program
- •Younger than 18 years old
结局指标
主要结局
Change from level of depression at the end of the pregnancy
时间窗: Up to 36 weeks
The Center for Epidemiological Studies-Depression scale (CES-D) was administered to all pregnant women at the beginning and at the end of their pregnancies
次要结局
- Fetal outcome(1-5 minutes after labor)
- Maternal outcome(Time spending in each stages of labor)
研究者
María Perales Santaella
PhD student
Technical University of Madrid