TaiChi ExerciseNCT01397318
Effects of Modified TaiChi Exercise on Maternal Stress, Fatigue, Sleep Quality, Biomarkers, and Infant Gestational Age and Birthweight
An observational study of TaiChi Exercise and Pregnant Women, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 17 years and older, women only
- Conditions the study is for
- TaiChi Exercise, Pregnant Women
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: pregnant women
Who may be able to join
- 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.
Who cannot join
- pregnant women who do not meet the recruitment criteria will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- TaiChi Exercise, Pregnant Women
- Keywords
- TaiChi Exercise, pregnant women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Not described | |
| Control Group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startSep 2010
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TaiChi ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Szu-Yuan Chou, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397318
- Sponsor's protocol ID
- 100005
- Status last verified
- Jul 2011
- First submitted
- 15 Jul 2011
- Last updated
- 19 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modified TaiChi Exercise on Maternal Stress, Fatigue, Sleep Quality, Biomarkers, and Infant Gestational Age and Birthweight
- ClinicalTrials.gov ID
- NCT01397318
- Acronym / sponsor ID
- 100005
- Conditions
- TaiChi Exercise, Pregnant Women
- Keywords
- TaiChi Exercise, pregnant women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Study completion
- Jul 2013 (estimated)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | – |
| Control Group | – | – |
Who may qualify
- Ages
- 17 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women
Key inclusion criteria (7 listed)
- Criteria for participation are women who:
Key exclusion criteria (1 listed)
- pregnant women who do not meet the recruitment criteria will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Szu-Yuan Chou principal investigator
Taipei Medical University WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TaiChi Exercise and Pregnant Women, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2011.