Tai Chi ChuanNCT05854680
To Investigate the Metabolomics in the Subjects With Long Term Tai Chi Chuan Practice
An observational study of Tai Chi Chuan and Metabolomics, run by Sheng-Teng Huang at 1 site in Taiwan.
Trial summary
The new biomedical technology including genomics and metabolomics will be applied to the subjects with TCC practice to investigate clinical symptoms and signs expression. The investigators will compare the related molecular pathways especially focusing on immune and inflammation between long term practice and beginner… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tai Chi Chuan, Metabolomics
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jan 2020to 10 Dec 2021
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The enrolled normal subjects were confirmed by the Tai Chi Association and the research PI. The long-term group has practiced Tai Chi for at least five years, and the short-term group has been practiced for less than three months. Men and women aged between 20 and 65 are included. We collected all of subjects' basic information, four diagnosis associated with TCM Syndrome Differentiation, FACIT-Fatigue scale, PSQI, BDI-II, SF-36 questionnaire scale, blood tests for CBC, liver and kidney function as well as metabolite analysis.
Who may be able to join
- Adult men and women aged over 20 and under 65.
- Participants agreed to join the trial by fully understanding the purpose of the study and the entire trial process and then signed an informed consent.
Who cannot join
- Age of subjects was under 20 or more than 65 years old.
- Subjects were using immunosuppressive or chemotherapy drugs.
- With a history of drug abuse.
- Pregnant or breastfeeding women.
- Mental or behavioral abnormalities such as schizophrenia, depression, suicidal ideation, etc.
- Suffering from serious diseases such as myocardial infarction, heart failure, arrhythmia, chronic respiratory obstructive diseases, cancers, gastrointestinal bleeding (OB positive), etc.
Show all 9Show fewer
- Subjects with abnormal blood count, abnormal liver function (>2 times the normal value), and abnormal renal function.
- Subjects were still participating in other clinical trials.
- Subjects were not willing sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The new biomedical technology including genomics and metabolomics will be applied to the subjects with TCC practice to investigate clinical symptoms and signs expression. The investigators will compare the related molecular pathways especially focusing on immune and inflammation between long term practice and beginner groups.
Read the detailed description
Tai Chi has been developed and spread in the eastern Asia, even the whole world for a long time. It is an exercise to coordinate mind, breathing and body movements slowly and continuously. Tai Chi is regarded as a good and useful sport to strengthen the body. In recent ten years, more and more evidence demonstrated the benefits of Tai Chi especially by meta-analysis studies. These studies revealed that Tai Chi can lower blood pressure, including systolic and diastolic blood pressure, fasting blood glucose, HbA1c, total cholesterol, triglyceride and low-density lipoprotein cholesterol, as well as preventing bone mineral density (BMD) loss in special populations. Tai Chi also helps the patients with Parkinson's disease reduce falls due to improving balance and functional mobility, and improve the symptoms of depression and anxiety. Recently, people are currently facing how to reduce the risk factors of cardiovascular diseases, promote physical and mental health and strengthen muscles and bones, and so on. Regarding the role of Tai Chi in immunity, Tai Chi is helpful to improve immune function, however, the results are still inconsistent that it needs to be elucidated.
Metabolomics technology is widely used in the fields of medicine and life sciences. Through mass spectrometry analysis, quantitative and qualitative changes in biomarkers can be used to identify biochemical metabolic pathways or effects that might be involved. The number of studies on metabolomics applications has grown rapidly over the past decade, however, little has been done to examine the physiological effects of Tai Chi practice. In addition, with the advancement of science and technology, the sensitivity and measurement method of the mass spectrometer have been improved, which is more suitable for understanding the physiological changes by Tai Chi exercises. After all, the exact cellular molecular mechanisms remain largely unknown after the practice of Tai Chi.
In order to understand the health care of Tai Chi, the investigators designed this clinical control study to observe its clinical benefits from both traditional Chinese medicine and Western medicine. The investigators mainly compared long-term Tai Chi practitioners with beginner by TCM diagnosis and physical analysis to identify the differences and changes in TCM syndromes. At the same time, modern medical-related molecular biotechnology is used to detect changes in immunity and metabolomics analysis. Based on the views from macro to micro, it may provide important clues for clinical trials of related diseases with application of Tai Chi exercise in the future.
- Conditions
- Tai Chi Chuan, Metabolomics
- Keywords
- Traditional Chinese medicine, Yin and Yang, Tai Chi Chuan, Metabolomics
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 |
|---|---|---|
| Long term | Tai Chi has been practiced for at least five years, regular practice, at least three times a week, each practice for at least 30 minutes. | |
| Short term | Tai Chi practice time is less than three months, regular practice, at least three times a week, each practice for at least 30 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum metabolites
Collect blood and measure the level of serum metabolites .
Measured: on the day of admission.
Plasma Cytokines
Collect blood and measure the level of plasma cytokines. Comparison of cytokine values between different groups.
Measured: on the day of admission.
Constitution in Chinese Medicine Questionnaire (CCMQ)
Measured: completed on the day of admission.
Secondary outcomes (4)
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4)
uses 13 short fatigue-related questions to measure an individual level of fatigue in daily life over the past week. Each rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). The scores for each item are summed to obtain a total score ranging from 0 to 52. A score of less than 30 indicates severe fatigue, and a higher score indicates less fatigue.
Measured: completed on the day of admission.
36-Item Short Form Health Survey (SF-36)
contains eight domains: physical functioning, physical health problems, bodily pain, general health perceptions, vitality, social functioning, emotional problems, and mental health. This is scored on a scale ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: completed on the day of admission.
Pittsburgh Sleep Quality Index (PSQI)
uses a self-administered questionnaire and fills in 19 items to evaluate sleep quality in the previous month
Measured: completed on the day of admission.
BDI-II score
consists of 21 sets of questions, each of which is self-administered with a score ranging from 0 to 3. Ultimately, a total score of 0-13 is considered minimal, 14-19 mild, 20-28 moderate, and 29-63 severe
Measured: completed on the day of admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start8 Jan 2020
- Primary completion2 Jul 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tai Chi ChuanStudies 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
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheng-Teng Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sheng-Teng Huang, China Medical University Hospital
- Investigators
- Sheng-Teng Huang, MD PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854680
- Sponsor's protocol ID
- CHUH108-REC2-020
- Status last verified
- May 2023
- First submitted
- 19 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Metabolomics in the Subjects With Long Term Tai Chi Chuan Practice
- ClinicalTrials.gov ID
- NCT05854680
- Acronym / sponsor ID
- CHUH108-REC2-020
- Conditions
- Tai Chi Chuan, Metabolomics
- Keywords
- Traditional Chinese medicine, Yin and Yang, Tai Chi Chuan, Metabolomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Sheng-Teng HuangUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 11 May 2023 (actual)
- 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.
The new biomedical technology including genomics and metabolomics will be applied to the subjects with TCC practice to investigate clinical symptoms and signs expression. The investigators will compare the related molecular pathways especially focusing on immune and inflammation between long term practice and beginner groups.
Detailed description
Tai Chi has been developed and spread in the eastern Asia, even the whole world for a long time. It is an exercise to coordinate mind, breathing and body movements slowly and continuously. Tai Chi is regarded as a good and useful sport to strengthen the body. In recent ten years, more and more evidence demonstrated the benefits of Tai Chi especially by meta-analysis studies. These studies revealed that Tai Chi can lower blood pressure, including systolic and diastolic blood pressure, fasting blood glucose, HbA1c, total cholesterol, triglyceride and low-density lipoprotein cholesterol, as well as preventing bone mineral density (BMD) loss in special populations. Tai Chi also helps the patients with Parkinson's disease reduce falls due to improving balance and functional mobility, and improve the symptoms of depression and anxiety. Recently, people are currently facing how to reduce the risk factors of cardiovascular diseases, promote physical and mental health and strengthen muscles and bones, and so on. Regarding the role of Tai Chi in immunity, Tai Chi is helpful to improve immune function, however, the results are still inconsistent that it needs to be elucidated.
Metabolomics technology is widely used in the fields of medicine and life sciences. Through mass spectrometry analysis, quantitative and qualitative changes in biomarkers can be used to identify biochemical metabolic pathways or effects that might be involved. The number of studies on metabolomics applications has grown rapidly over the past decade, however, little has been done to examine the physiological effects of Tai Chi practice. In addition, with the advancement of science and technology, the sensitivity and measurement method of the mass spectrometer have been improved, which is more suitable for understanding the physiological changes by Tai Chi exercises. After all, the exact cellular molecular mechanisms remain largely unknown after the practice of Tai Chi.
In order to understand the health care of Tai Chi, the investigators designed this clinical control study to observe its clinical benefits from both traditional Chinese medicine and Western medicine. The investigators mainly compared long-term Tai Chi practitioners with beginner by TCM diagnosis and physical analysis to identify the differences and changes in TCM syndromes. At the same time, modern medical-related molecular biotechnology is used to detect changes in immunity and metabolomics analysis. Based on the views from macro to micro, it may provide important clues for clinical trials of related diseases with application of Tai Chi exercise in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long term | – | –Tai Chi has been practiced for at least five years, regular practice, at least three times a week, each practice for at least 30 minutes. |
| Short term | – | –Tai Chi practice time is less than three months, regular practice, at least three times a week, each practice for at least 30 minutes. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The enrolled normal subjects were confirmed by the Tai Chi Association and the research PI. The long-term group has practiced Tai Chi for at least five years, and the short-term group has been practiced for less than three months. Men and women aged between 20 and 65 are included. We collected all of subjects' basic information, four diagnosis associated with TCM Syndrome Differentiation, FACIT-Fatigue scale, PSQI, BDI-II, SF-36 questionnaire scale, blood tests for CBC, liver and kidney function as well as metabolite analysis.
Key inclusion criteria (2 listed)
- Adult men and women aged over 20 and under 65.
- Participants agreed to join the trial by fully understanding the purpose of the study and the entire trial process and then signed an informed consent.
Key exclusion criteria (9 listed)
- Age of subjects was under 20 or more than 65 years old.
- Subjects were using immunosuppressive or chemotherapy drugs.
- With a history of drug abuse.
- Pregnant or breastfeeding women.
- Mental or behavioral abnormalities such as schizophrenia, depression, suicidal ideation, etc.
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
Serum metabolites
Time frame: on the day of admission.
Collect blood and measure the level of serum metabolites .
Plasma Cytokines
Time frame: on the day of admission.
Collect blood and measure the level of plasma cytokines. Comparison of cytokine values between different groups.
Constitution in Chinese Medicine Questionnaire (CCMQ)
Time frame: completed on the day of admission.
4 secondary outcomes
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4)
Time frame: completed on the day of admission.
36-Item Short Form Health Survey (SF-36)
Time frame: completed on the day of admission.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: completed on the day of admission.
BDI-II score
Time frame: completed on the day of admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
Related trials for Tai Chi Chuan
Recruiting
Feasibility of A Smartphone Application Intervention in Community Settings: A Pretest-Posttest Pilot Study
Aging, Dementia
Recruiting
Temporal Interference Stimulation Combined With Tai Chi for Mild Cognitive Impairment
Mild Cognitive Impairment (MCI)
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
Not yet recruiting
Online Tai Chi Versus Digital CBT-I for Chronic Insomnia
Chronic Insomnia Disorder
Active, not recruiting
Effects of VR Tai Chi Intervention on Physical Fitness, Anxiety, Depression and Stress Among College Students in Henan, China
Health College Students
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.
Sheng-Teng Huang, MD PhD principal investigator
China Medical University 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 Tai Chi Chuan and Metabolomics, run by Sheng-Teng Huang 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 11 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Serum metabolites (time frame: on the day of admission.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 11 May 2023.