Remote Tai Chi for Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote Tai Chi.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: 50 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial
Overview
The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are: * Compared to routine care, will patients with Knee OA receiving remote Tai Chi exhibit greater improvement in knee-related pain (WOMAC pain score, primary outcome), pain interference (PROMIS-Pain Interference, secondary outcome), and health-related quality of life at 3 months? * Does remote tai chi decreases healthcare utilization and analgesic use over the one-year study period? Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization.
Detailed description
Investigators will conduct a 12-month embedded, pragmatic, hybrid type 1 effectiveness-implementation, individually randomized group-treatment trial that will compare the effects of a 3-month twice weekly remotely delivered web-based Tai Chi intervention plus routine care versus routine care alone across four health care systems (Tufts Medical Center, Boston Medical Center, University of California Los Angeles Health, and Cleveland Clinic) in four geographic regions (Eastern Massachusetts, Southern California, Northeast Ohio (Cleveland Clinic), Southern Florida (Cleveland Clinic). Investigators will enroll a total of 480 diverse patients with a clinical diagnosis of Knee OA. Participants will be evaluated at baseline and 3 months, with additional follow-up at 6 and 12 months.
Interventions
- Other Remote Tai Chi
Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements.
Primary outcome measures
- WOMAC Pain Score [Time frame: 3 months from randomization]
Secondary outcome measures (3)
- PROMIS Pain Interference score [Time frame: 3 months from randomization]
- SF-12 PCS score [Time frame: 3 months from randomization]
- Number of knee joint injections [Time frame: 12 months from randomization]
Eligibility criteria
Inclusion criteria
- Age 50 years or older
- Treating clinician diagnosis of knee osteoarthritis
- Have a score of 40 (visual analog version) or greater on at least 1 of the 5 questions in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (range of 0 to 100, with higher scores indicating greater pain) at baseline.
- Able to provide informed consent
- If randomized to the Routine Care group, willing to abstain from Tai Chi programs until completion of the study
- If randomized to the Tai Chi group, willing to comply with the Tai Chi program (twice-a-week remote sessions for 12 weeks)
- Has access to a home computer or device that will allow telehealth (bidirectional audio and video) delivery of the intervention
- Is an active patient at one of the 4 participating healthcare system
Exclusion criteria
- Currently practicing Tai Chi
- Serious medical conditions (e.g., dementia, significant neurological deficits or neurodegenerative disorder, active cancer treatment, psychosis, sensory deficits) limiting the participant's ability to participate in the Tai Chi safely, as determined by the principal investigators
- Unable to walk without a cane or other assistive device
- Any previous or scheduled knee replacement
- Reports severe depression defined by a Beck Depression Inventory (BDI-II) score of 29 or more.
- Reports suicidal ideations defined by a score on BDI-II item of 2 or 3 ('I would like to kill myself' or 'I would kill myself if I had the chance').
- Not English speaking
- Enrollment in any other clinical trial within the last 30 days
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Tufts Medical Center — Boston
Identifiers
NCT: NCT06384898 · STUDY00002259 · UH3AT012413