- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01397318
Effects of Modified TaiChi Exercise on Maternal Stress, Fatigue, Sleep Quality, Biomarkers, and Infant Gestational Age and Birthweight
July 18, 2011 updated by: Taipei Medical University WanFang Hospital
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.
Study Overview
Status
Unknown
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan
- Taipei Medical University-WanFang Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
pregnant women
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control Group
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Experimental Group
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Szu-Yuan Chou, Taipei Medical University WanFang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Study Completion (Anticipated)
July 1, 2013
Study Registration Dates
First Submitted
July 15, 2011
First Submitted That Met QC Criteria
July 18, 2011
First Posted (Estimate)
July 19, 2011
Study Record Updates
Last Update Posted (Estimate)
July 19, 2011
Last Update Submitted That Met QC Criteria
July 18, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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