To Investigate the Metabolomics in the Subjects With Long Term Tai Chi Chuan Practice

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.

Study Overview

• Status: Completed
• Conditions: Metabolomics; Tai Chi Chuan

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 Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Taiwan
  • North District
    • Taichung, North District, Taiwan, 404
      • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Adult men and women aged over 20 and under 65.
2. 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.

Exclusion Criteria:

1. Age of subjects was under 20 or more than 65 years old.
2. Subjects were using immunosuppressive or chemotherapy drugs.
3. With a history of drug abuse.
4. Pregnant or breastfeeding women.
5. Mental or behavioral abnormalities such as schizophrenia, depression, suicidal ideation, etc.
6. Suffering from serious diseases such as myocardial infarction, heart failure, arrhythmia, chronic respiratory obstructive diseases, cancers, gastrointestinal bleeding (OB positive), etc.
7. Subjects with abnormal blood count, abnormal liver function (>2 times the normal value), and abnormal renal function.
8. Subjects were still participating in other clinical trials.
9. Subjects were not willing sign the informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum metabolites	Collect blood and measure the level of serum metabolites .	on the day of admission.
Plasma Cytokines	Collect blood and measure the level of plasma cytokines. Comparison of cytokine values between different groups.	on the day of admission.
Constitution in Chinese Medicine Questionnaire (CCMQ)		completed on the day of admission.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	completed on the day of admission.

Collaborators and Investigators

• Sponsor: Sheng-Teng Huang
• Investigators: Principal Investigator: Sheng-Teng Huang, MD PhD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): July 2, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Estimate): May 11, 2023

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Metabolomics; Traditional Chinese medicine; Tai Chi Chuan; Yin and Yang
• Other Study ID Numbers: CHUH108-REC2-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No