Effect of Tai Chi Exercise on Mechanical Joint Loading in Knee Osteoarthritis

September 8, 2025 updated by: Edward Via Virginia College of Osteopathic Medicine

Real Time Biofeedback Tai Chi Training for Knee Osteoarthritis: A Feasibility Study

This project is designed to identify the biomechanical mechanisms of Tai Chi (TC) exercise and test a novel optimized TC intervention by modifying newly identified mechanisms for those with knee osteoarthritis (OA) and to assess the changes in mechanical load with the intervention. It combines unique real time torque biofeedback approach, and uses external knee adduction moment (EKAM) as modulation target tailored to TC intervention in this population. The potential benefit from this project is to provide biomechanical insights of TC and this novel TC approach may produce meaningful changes of mechanical load in these patients who can learn and practice safely during this intervention.

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

Disabilities that arise from typical impairments of knee osteoarthritis (OA) include decreased muscle strength, reduced range of motion, and decreased aerobic cardiovascular function. A large number of individuals with knee OA experience disability and require rehabilitation. Traditional TC intervention has been a promising therapeutic intervention in knee OA, but the efficacy of TC as a knee OA intervention has proven inconclusive presumably because individuals with knee OA perform different TC components (steps) with widely varying mechanical knee joint loads. This variation could be a confounding factor in the way in which TC affects knee OA. Therefore, a feasibility study is proposed here to quantify external knee adduction moment (EKAM) response to the different TC steps, and then determine if it is feasible to use biofeedback of torque acting on the knee to modify some TC steps so as to reduce the EKAM they produce. Those TC steps whose EKAM can be easily reduced below mean EKAM during walking and those already below that level will constitute an optimized form of TC for knee OA; the remainder will be discarded. A phase 1 randomized controlled trial will be conducted to compare the optimized TC intervention to traditional TC training in reducing EKAM. The proposed research represents the first study to identify the biomechanical mechanisms of TC and to target EKAM by using a real-time biofeedback approach to manipulate EKAM during TC performance.

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.
15

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

  • United States
    • Texas
      • San Antonio, Texas, United States, 78258
        • UT Health San Antonio, Rehabilitation Biomechanics Lab

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • OA participants will be diagnosed based on the American College of Rheumatology classification criteria.
  • Knee pain average level > 3 cm on a 10 cm visual analog scale,
  • Kellgren / Lawrence scale of 2-3 on radiographs.
  • Pain/tenderness over the medial region or lateral region of the knee on physical examination.
  • The participants will have 40 years of age or older and have no TCC experience prior this study.

Exclusion Criteria:

  • a history of lower extremity joint replacement
  • intra-articular knee injection (steroid, hyaluronic acid) within the previous 6 months
  • systemic rheumatoid arthritic condition affecting the knee clinically or radiographically,
  • report of any of the following health problems (heart condition, chest pain during periods of activity or rest)
  • currently seeking or receiving physical therapy for knee OA,
  • having a medical condition precluding the participant from undergoing physical activity or biomechanical gait analysis.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
Experimental: optimized Tai Chi intervention
Behavioral: Optimized Tai Chi intervention
Optimized Tai Chi intervention
Other Names:
  • OTC
Active Comparator: traditional Tai Chi intervention
Behavioral: Traditional Tai Chi intervention
Traditional Tai Chi intervention
Other Names:
  • TTC

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
change from baseline knee joint mechanical load at 4 weeks
Time Frame: baseline and 4 weeks
knee joint mechanical load will be measured by using high speed cameras and force plates to estimate external knee adduction moment (EKAM)
baseline and 4 weeks

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.
Edward Via Virginia College of Osteopathic Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)
The University of Texas Health Science Center at San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 27, 2018

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.
July 31, 2024

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.
July 31, 2024

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).
July 31, 2018

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.
August 3, 2018

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.
August 8, 2018

Study Record Updates

Last Update Posted (Estimated)

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.
September 15, 2025

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.
September 8, 2025

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.
February 1, 2024

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.
  • 2016-050
  • 1K23AT009568-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary outcome measure will be made available

IPD Sharing Time Frame

Data will be available within 6 month of study completion

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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