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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01397318
First received: July 15, 2011
Last updated: July 18, 2011
Last verified: July 2011

July 15, 2011
July 18, 2011
September 2010
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Complete list of historical versions of study NCT01397318 on ClinicalTrials.gov Archive Site
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Effects of Modified TaiChi Exercise on Maternal Stress, Fatigue, Sleep Quality, Biomarkers, and Infant Gestational Age and Birthweight
Effects of Modified TaiChi Exercise on Maternal Stress, Fatigue, Sleep Quality, Biomarkers, and Infant Gestational Age and Birthweight

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

pregnant women

  • TaiChi Exercise
  • Pregnant Women
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  • Experimental Group
  • Control Group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
July 2013
Not Provided

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • pregnant women who do not meet the recruitment criteria will be excluded from the study.
Female
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01397318
100005
No
Szu-Yuan Chou, Department of Obsterics & Gynecology, WanFang Hospital
Taipei Medical University WanFang Hospital
Not Provided
Principal Investigator: Szu-Yuan Chou Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP