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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03621631
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Edward Via Virginia College of Osteopathic Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis

Additional Details

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.

Arms & Interventions

Arms

Experimental: optimized Tai Chi intervention

optimized Tai Chi intervention

Active Comparator: traditional Tai Chi intervention

traditional Tai Chi intervention

Interventions

Behavioral: - Optimized Tai Chi intervention

Optimized Tai Chi intervention

Behavioral: - Traditional Tai Chi intervention

Traditional Tai Chi intervention

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Antonio, Texas

Status

Recruiting

Address

UT Health San Antonio, Rehabilitation Biomechanics Lab

San Antonio, Texas, 78258

Site Contact

Wei Liu, PhD

[email protected]

210-567-4838

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