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临床试验/NCT03688087
NCT03688087已完成不适用

Study of Program Interest "Bouge" to Improve the Daily Physical Activity and Tolerance in Processings Treatment of Pregnant Women

University Hospital, Brest4 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年8月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
4
主要终点
Increased daily physical activity (number of steps) using the smartphone application "BOUGE"

研究概览

简要总结

Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of pregnant patients beguining at 15 SA

详细描述

Controlled, randomized, open, prospective, multicentric study, 250 pregnant patients aged between 18 and more, with 14 weeks of amenorrhea, possessing a smartphone, will be recruited and randomized into two groups:

125 in the control group (smartphone application "placebo" = number of steps) 125 will be equipped with the application "Bouge" = coached group

For three months, the patients do their daily physical activity. The "coached" group, through the smartphone application "Bouge", receives computer coaching to increase their physical activity (no direct medical intervention, only notifications and computer pusch).

The control group is not coached by the application (simple display of the number of step)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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 <14 weeks of amenorrhea Must have a compatible smartphone

排除标准

  • •Multiple pregnancies Pre-existing pregnancy-related diseases Pregnancy complicated History of peripheral arterial disease History of IUGR History of cone biopsy History of delivery hemorrhage

研究组 & 干预措施

placebo

Placebo Comparator

Smartphone application "placebo"

干预措施: Smartphone application "placebo" (Device)

"Bouge"

Active Comparator

Smartphone equipped with the application "Bouge"

干预措施: Smartphone equipped with application "bouge" = Coach group (Device)

结局指标

主要结局

Increased daily physical activity (number of steps) using the smartphone application "BOUGE"

时间窗: 12 Weeks

The objective is an increase of 2000 steps daily between J 1 and J 90 (an increase of 10 000 steps between S1 and S 12)

次要结局

  • - lumbago(12 Weeks)
  • Well being(12 Weeks)
  • sleep,(12 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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