After Cesarean Time Interval for Exercise (ACTIVE) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in wellness
研究概览
简要总结
The purpose of this study is to test whether or not activity restrictions after a cesarean section are warranted and if exercise can improve postpartum wellness. This research study is being done because there is no science-based evidence to support postpartum activity restrictions after cesarean sections.
Participants will be randomly placed into one of the following study groups:
- Standard postpartum and post-operative instructions group: activity restrictions, including no strenuous exercise, sexual intercourse, or lifting objects greater than 25 pounds for 6 weeks or until evaluation at the 6 week postpartum visit
- Study group: Structured 10 week exercise protocol consisting of core strengthening exercises (concentrating on the abdominal, gluteal, and pelvic areas), breathing exercises, and diaphragm exercises.
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
- None
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 woman at least 18 years of age
- •carrying only one baby at time of delivery
- •delivery planned by scheduled cesarean section
- •baby of gestational age of > 37 weeks
- •no known restrictions to exercise.
排除标准
- •woman with pre-existing post operative complications
- •medical history with exercise limitations/disabilities
- •carrying more than one baby at time of delivery
- •delivery (planned by scheduled or emergent) cesarean section with fetal concerns (anomaly, growth restriction, NICU admission, etc)
研究组 & 干预措施
Standard instructions
Standard instructions: activity restrictions, including no strenuous exercise, sexual intercourse, or lifting objects greater than 25 pounds for 6 weeks or until evaluation at the 6 week postpartum visit
Study Group
Study group: Structured 10 week exercise protocol
干预措施: Structured exercise (Behavioral)
结局指标
主要结局
Change in wellness
时间窗: 2, 6, and 10 weeks
As measured by scores in the completion of the PROMIS GSF assessment. The PROMIS GSF assessment uses a method of scoring requiring responses to each item for each participant. Each question usually has five response options ranging in value from one to five. All questions must be answered in order to produce a valid score using the scoring tables. A score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average. By comparison, an Anxiety T-score of 40 is one SD better than average. However, for positively-worded concepts like Physical Function-Mobility, a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.
次要结局
- Change in incidence of post operative complications(2, 6, and 10 weeks)
- Change in incidence of depression, anxiety, and decreased physical functioning(2, 6, and 10 weeks)