Effect of Tai Chi Exercise on Mechanical Joint Loading in Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optimized Tai Chi intervention
Traditional Tai Chi intervention
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, Tai Chi, Biofeedback, External Knee Adduction Moment
Eligibility 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.
Sites / Locations
- UT Health San Antonio, Rehabilitation Biomechanics LabRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
optimized Tai Chi intervention
traditional Tai Chi intervention
Arm Description
optimized Tai Chi intervention
traditional Tai Chi intervention
Outcomes
Primary Outcome Measures
change from baseline knee joint mechanical load at 4 weeks
knee joint mechanical load will be measured by using high speed cameras and force plates to estimate external knee adduction moment (EKAM)
Secondary Outcome Measures
Full Information
NCT ID
NCT03621631
First Posted
July 31, 2018
Last Updated
February 13, 2023
Sponsor
Edward Via Virginia College of Osteopathic Medicine
Collaborators
National Center for Complementary and Integrative Health (NCCIH), The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT03621631
Brief Title
Effect of Tai Chi Exercise on Mechanical Joint Loading in Knee Osteoarthritis
Official Title
Real Time Biofeedback Tai Chi Training for Knee Osteoarthritis: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edward Via Virginia College of Osteopathic Medicine
Collaborators
National Center for Complementary and Integrative Health (NCCIH), The University of Texas Health Science Center at San Antonio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, Tai Chi, Biofeedback, External Knee Adduction Moment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
optimized Tai Chi intervention
Arm Type
Experimental
Arm Description
optimized Tai Chi intervention
Arm Title
traditional Tai Chi intervention
Arm Type
Active Comparator
Arm Description
traditional Tai Chi intervention
Intervention Type
Behavioral
Intervention Name(s)
Optimized Tai Chi intervention
Other Intervention Name(s)
OTC
Intervention Description
Optimized Tai Chi intervention
Intervention Type
Behavioral
Intervention Name(s)
Traditional Tai Chi intervention
Other Intervention Name(s)
TTC
Intervention Description
Traditional Tai Chi intervention
Primary Outcome Measure Information:
Title
change from baseline knee joint mechanical load at 4 weeks
Description
knee joint mechanical load will be measured by using high speed cameras and force plates to estimate external knee adduction moment (EKAM)
Time Frame
baseline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UT Health San Antonio, Rehabilitation Biomechanics Lab
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Liu, PhD
Phone
210-567-4838
Email
liuw1@uthscsa.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Effect of Tai Chi Exercise on Mechanical Joint Loading in Knee Osteoarthritis
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