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临床试验/NCT04527731
NCT04527731已完成不适用

Fit for Two - A Pilot Study on Physical Activity Levels During Pregnancy

University Medicine Greifswald1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Extent and intensity of physical activity between pregnancy week 9 and 12

研究概览

简要总结

This study examines (1) the extent and intensity of physical activity among women in different phases of their pregnancy and (2) the relationship between patterns of physical activity in pregnancy and well-being.

详细描述

This study examines physical activity in different phases of pregnancy using accelerometry. The recruitment of pregnant women (N=30) in the first or second trimester (until week 23) will be realized over different channels (e.g, local newspapers, facebook, and leaflets in gynecological practices, shopping centers, and nurseries).

Informed consent consists of: (i) activity recording over seven consecutive days using an accelerometer, (ii) completion of standardized questionnaires, (iii) participation in a cardiac ultrasound examination in the German Center for Cardiovascular Research (DZHK) - examination center.

Participants are asked to wear an accelerometer at daytime, and over seven consecutive days, in trimester 1 (week 9-12), trimester 2 (week 23-26), and trimester 3 (week 36-39). Women who are attended the study in the first trimester wear the device up to three time whereas those who are attended the study in their second trimester wear the device up to twice. At the end of each measurement period women are invited to fill in a self-administered questionnaire. Also they are invited to participate in a cardiac ultrasound examination. Optionally, participants may receive feedback on their physical activity measured by accelerometer as well as about results of cardiac ultrasound examination upon completion of the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • current pregnancy, until pregnancy week 23

排除标准

  • cognitive impairment
  • insufficient language skills

结局指标

主要结局

Extent and intensity of physical activity between pregnancy week 9 and 12

时间窗: between pregnancy week 9 and 12

Assessement via accelerometry

Extent and intensity of physical activity between pregnancy week 36 and 39

时间窗: between pregnancy week 36 and 39

Assessement via accelerometry

Extent and intensity of physical activity between pregnancy week 23 and 26

时间窗: between pregnancy week 23 and 26

Assessement via accelerometry

次要结局

  • Left ventricular muscle mass index(Echocardiography between pregnancy week 36 and 39)
  • Echocardiographic global strain, in %(Echocardiography between pregnancy week 36 and 39)
  • Well-being(between pregnancy week 36 and 39)
  • Mother-child bond(between pregnancy week 36 and 39)
  • Sociodemographics(between pregnancy week 9 and 12)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (1)

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