Effect of Group Exercise on Mental Wellbeing Among Pregnant Women at Risk of Perinatal Depression: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- World Health Organisation Five Well-being Index (WHO-5).
研究概览
简要总结
The purpose of this study is to examine the effect of supervised group exercise on mental wellbeing and signs of depression among pregnant women at risk of perinatal depression in a randomized controlled clinical trial.
The investigators hypothesis is that 70 minutes of supervised group exercise twice a week for 12 weeks by pregnant women at risk of perinatal depression, will improve the participants mental wellbeing and reduce their symptoms of depression.
详细描述
Pregnant women with a current or a previous history of depression and/or anxiety have a significantly increased risk of perinatal depression and disruptions in the mother-infant attachment. In addition, pregnant women with anxiety and/or depression are at higher risk of preterm birth, low birth weight, and complications during birth.
It is well described that physical exercise in general is associated with psychological well-being and a reduced risk of morbidity and mortality in non-pregnant women. Several studies have documented that physical exercise during pregnancy is associated with health benefits for both infants and mothers. Physical exercise during pregnancy is associated with a lower risk of pregnancy- and delivery related complications such as preeclampsia, gestational diabetes mellitus, low back pain, preterm delivery, emergency caesarean section and postpartum depression, as well as contributing to improved mood.
Nevertheless, in the existing literature there are few and only small studies which have examined the effect of exercise on depression among mentally vulnerable pregnant women.
The aim of this study is to examine the effect of supervised group training for pregnant women with a current or a previous history of depression and/or anxiety.
Patient enrollment. The participants will be recruited from the Department of Obstetrics, Rigshospitalet, Denmark, from July 2016 to March 2019. Participants will be selected on the basis of 1) the information provided by the participants general practitioner and 2) an electronic questionnaire received by email and completed by all pregnant women registered to give birth at Rigshospitalet. The information from the questionnaire is routinely transferred to the pregnant women´s medical records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with depression and/or anxiety requiring treatment within the last ten years, and/or intake of antidepressants in the last three months before conception and/or during pregnancy.
- •Age ≥18 years
- •Singelton pregnancy
- •17th - 22th week of gestation by intervention start
- •Appropriate Danish language skills
- •Written informed consent
排除标准
- •Age <18 years
- •Multiple pregnancies
- •Abuse problems
- •Eating disorders
- •Women who have been diagnosed with malformations or chromosomal disorder in the fetus
- •Pelvic instability problems in earlier pregnancy (diagnosed by physiotherapist or doctor)
- •Severe obstetric complications.
- •Withdrawal criteria. Participants will be withdrawal from the study after randomization, if one or more of the following criteria are met:
- •Occurred pelvic instability
- •Preeclampsia
- •Vaginal bleeding
- •Other factors indicating an increased risk of preterm birth.
研究组 & 干预措施
control group
Standard care, mentally vulnerable women
group exercise
Supervised Group training
干预措施: group exercise (Behavioral)
结局指标
主要结局
World Health Organisation Five Well-being Index (WHO-5).
时间窗: 29th-34th week of gestation
Psychological well-being will be measured by the World Health Organisation Five Well-being Index (WHO-5) (mean and SD) or (median and range). Please see the published study protocol Broberg et al. Trials (2017) 18:210.
次要结局
- Spielbergers State Anxiety Inventory (STAI)(29th-34th week of gestation and 2 months after delivery)
- Edinburgh Postnatal Depression Scale (EPDS)(29th-34th week of gestation and 2 months after delivery)
- The 12-item General Health Questionnaire (GHQ-12)(29th-34th week of gestation and 2 months after delivery)
- Pittsburgh Sleep Quality Index (PSQI)(29th-34th week of gestation and 2 months after delivery)
- Percentage of participants with sick leave(29th-34th week of gestation)
- Hospitalization, length of stay(2 weeks post partum)
- Duration of labor(2 weeks post partum)
- Birth length in centimeters(2 weeks post partum)
- Antenatal contacts(2 weeks post partum)
- Use of epidural anaesthesia(2 weeks post partum)
- Percentage of participants with respectively spontaneous onset of labor or inducted labor(2 weeks post partum)
- Mode of delivery. Percentage of participants with respectively spontaneous delivery, vacuum extraction or cesarean section(2 weeks post partum)
- Birth weight in kilograms(2 weeks post partum)
- World Health Organisation Five Well-being Index (WHO-5).(2 months after delivery)
- Consultations by telephone(2 weeks post partum)
研究者
Hanne Kristine Hegaard
Midwife, PhD, Associate professor
Rigshospitalet, Denmark