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临床试验/NCT01397318
NCT01397318Unknown不适用

Effects of Modified TaiChi Exercise on Maternal Stress, Fatigue, Sleep Quality, Biomarkers, and Infant Gestational Age and Birthweight

Taipei Medical University WanFang Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1

研究概览

简要总结

Many pregnant women experience stress, fatigue, and poor sleep quality that may influence infant outcomes such as prematurity and low birthweight through immunologic pathway of biomarkers (serum cytokines and c-reactive protein). In contrast, TaiChi exercise, one kind of physical activity, can increase pulmonary and immune functions and reduce stress may therefore prevent pregnancy complications and further prevent adverse pregnancy outcomes; however, its effects has not been explored in studies. Therefore, this study aims to investigate relationships between prenatal stress, fatigue, sleep quality, biomarkers, and infant outcomes; modified a TaiChi exercise program suitable for pregnant women; and test the effects of the exercise on reducing stress and fatigue, promote sleep quality, modulate biomarkers, and prevent adverse infant outcomes. Infant outcomes in the study will be measured with gestational age and birthweight. The study is a three-stage longitudinal interventional design.

详细描述

In the first-stage, patterns of prenatal stress, fatigue, and sleep quality will be investigated by surveying 300 pregnant women who are over 23 weeks of gestation and screen for pregnant women with fatigue and poor sleep quality. In the second-stage, experts in obstetrics and TaiChi will be invited to modify a TaiChi exercise program. Thirty women who experience fatigue and poor sleep quality will be invited to practice the modified TaiChi exercise. Comments from those participants on the program will be used to refine the program and a DVD will be made. After the program is well-designed and recorded, participants recruited for the third-stage study will be randomly assigned to TaiChi or comparison group. They will be asked to complete questionnaires and give blood samples for biomarker tests when they are at 27-29, 31-33, and 35-37 weeks of gestation; in labor; and at 4-6 weeks postpartum. In addition to practice the exercise at home, participants in the TaiChi group will practice TaiChi in groups every month. In contrast, comparison group will be asked to keep on their usual daily activities, no other interventions will be introduced. Phone calls or postcard will be made or sent routinely to participants to ensure their long-term participation. Questionnaires used for the study include 10-item Perceived Stress Scale, Multidimensional Assessment of Fatigue Scale, and Pittsburgh Sleep Quality Index. Descriptive statistics, Pearson correlation, and generalized estimating equations will be applied to understand predictive effects of maternal stress, fatigue, sleep quality, and biomarkers on infant outcomes; and effects of modified TaiChi exercise on maternal stress, fatigue, sleep quality, biomarkers, and infant outcomes. In addition to develop a modified TaiChi exercise program suitable for pregnant women, the study anticipates that maternal stress, fatigue, and poor sleep quality can predict infant outcomes through immunologic pathway, and the modified TaiChi exercise can reduce maternal stress and fatigue, improve sleep quality, modulate biomarkers, and hence prevent adverse infant outcomes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Criteria for participation are women who:
  • are over 17;
  • can read Chinese;
  • are at or over 24 weeks of gestation;
  • pregnant with singleton;
  • are not diagnosed of pregnancy complications such as preeclampsia, preterm labor, preterm rupture of membranes, gestational diabetes, and cervical incompetence before recruitment; and
  • are willing to complete questionnaires and give blood samples.

排除标准

  • pregnant women who do not meet the recruitment criteria will be excluded from the study.

研究者

申办方类型
Other

研究点 (1)

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