The Application of Traditional Chinese Medicine Functional Reduction in Muscle Fatigue

June 4, 2021 updated by: Han-Kuei Wu, China Medical University, Taiwan
In this study, 45 healthy participants between 20 and 40 of age will be included. After obtaining the consent, the participants will be categorized into two(A&B) groups randomly for cross-over study. Each of group will accept either conventional taping or Chinese medicine technique taping before muscle fatigue exercise. To compare the preventive effect, Myoton PRO, pulse analysis equipment, etc will be applied for evaluation. The application of Chinese medicine technique (ie. Chinese medicine functional reduction) taking the kinetic chain into consideration may improve body's functional movement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Nowadays, the importance of exercise is highly valued. The prevalence of sports injury is also increasing and may be associated with muscle fatigue. Therefore, the study focused on the prevention of common muscle fatigue in legs during exercise. With the modern sport medicine knowledge and kinesio taping, the investigators tried to figure out whether muscle fatigue can be diminished through the concept of Chinese medicine channel sinews techniques in advance. In this study, 45 healthy participants between 20 and 40 of age will be included. The exclusion criteria are as follows: i.pregnancy ii.current health problem iii.injuries of legs within a month. After obtaining the consent, the participants will be categorized into two(A&B) groups randomly for cross-over study. Each of group will accept either conventional taping or Chinese medicine technique taping before muscle fatigue exercise. To compare the preventive effect, Myoton PRO, pulse analysis equipment, etc will be applied for evaluation. The application of Chinese medicine technique (ie. Chinese medicine functional reduction) taking the kinetic chain into consideration may improve body's functional movement. Our goal is to enhance the coordination of the entire body structure, not merely the partial body structure improvement. In this way, it will benefit the prevention of exercise injuries and therapeutic effect.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • participants between 20 and 40 of age

Exclusion Criteria:

  • i.pregnancy ii.current health problem iii.injuries of legs within a month

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: conventional taping-Chinese medicine technique taping
Participants will accept conventional taping before muscle fatigue exercise for the first course then accept Chinese medicine technique taping before muscle fatigue exercise for the second course.
Procedure: conventional taping
Participants will accept conventional taping before muscle fatigue exercise.
Procedure: Chinese medicine technique taping
Participants will accept Chinese medicine technique taping before muscle fatigue exercise.
Other: Chinese medicine technique taping-conventional taping
Participants will accept Chinese medicine technique taping before muscle fatigue exercise for the first course then accept conventional technique taping before muscle fatigue exercise for the second course.
Procedure: conventional taping
Participants will accept conventional taping before muscle fatigue exercise.
Procedure: Chinese medicine technique taping
Participants will accept Chinese medicine technique taping before muscle fatigue exercise.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle tone
Time Frame: one week
The soft tissue will be evaluated by Myoton PRO. The muscle tone is measured by the "oscillation frequency (HZ)" characterizing the tone of a muscle in its passive or resting state without any voluntary contraction. Abnormally high muscle tine would slow the muscle recovery.
one week
Muscle stiffness
Time Frame: one week
The soft tissue will be evaluated by Myoton PRO. The muscle stiffness is evaluated by the "dynamic stiffness (N/m)" characterizing the resistance to a contraction or to an external force that deforms its initial shape. Abnormally high stiffness may lead to an inefficient economy of movement.
one week
Muscle elasticity
Time Frame: one week
The muscle elasticity is evaluated by the "logarithmic decrement" of a tissue's natural oscillation characterizing the ability to recover its initial shape after a contraction of removal an external force of deformation. If the decrement of a muscle decreases, the muscle elasticity increases.
one week
Muscle relaxation
Time Frame: one week
The muscle relaxation is evaluated by the "mechanical stress relaxation time (ms)" characterizing the time for a muscle to recover its shape from deformation after a voluntary contraction or a removal of an external force.
one week
Muscle creep
Time Frame: one week
The creep is evaluated by the "ratio of deformation and relaxation time" characterizing the gradual elongation of tissue over time when placed under a constant tensile stress.
one week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain scale
Time Frame: one week
Pain assessment by the Wong-Baker Faces Pain Rating Scale. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".
one week
Pulse wave
Time Frame: one week
Radial pulse wave analysis
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Medical University, Taiwan

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCM-Taping

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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