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

Sponsor
Sheng-Teng Huang (Other)
Overall Status
Completed
CT.gov ID
NCT05854680
Collaborator
(none)
56
1
23.1
2.4

Study Details

Study Description

Brief 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 groups.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    56 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    To Investigate the Metabolomics in the Subjects With Long Term Tai Chi Chuan Practice
    Actual Study Start Date :
    Jan 8, 2020
    Actual Primary Completion Date :
    Jul 2, 2021
    Actual Study Completion Date :
    Dec 10, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Serum metabolites [on the day of admission.]

      Collect blood and measure the level of serum metabolites .

    2. Plasma Cytokines [on the day of admission.]

      Collect blood and measure the level of plasma cytokines. Comparison of cytokine values between different groups.

    3. Constitution in Chinese Medicine Questionnaire (CCMQ) [completed on the day of admission.]

    Secondary Outcome Measures

    1. Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4) [completed on the day of admission.]

      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.

    2. 36-Item Short Form Health Survey (SF-36) [completed on the day of admission.]

      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.

    3. Pittsburgh Sleep Quality Index (PSQI) [completed on the day of admission.]

      uses a self-administered questionnaire and fills in 19 items to evaluate sleep quality in the previous month

    4. BDI-II score [completed on the day of admission.]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 China Medical University Hospital Taichung North District Taiwan 404

    Sponsors and Collaborators

    • Sheng-Teng Huang

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheng-Teng Huang, Attending physician, China Medical University Hospital
    ClinicalTrials.gov Identifier:
    NCT05854680
    Other Study ID Numbers:
    • CHUH108-REC2-020
    First Posted:
    May 11, 2023
    Last Update Posted:
    May 11, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sheng-Teng Huang, Attending physician, China Medical University Hospital

    Study Results

    No Results Posted as of May 11, 2023