Remote Tai Chi for Knee Osteoarthritis (TAICHIKNEE)

Tufts University

Status: Begins enrollment in 1 month

Conditions: Knee Osteoarthritis

Treatments: Other: Remote Tai Chi

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06384898

STUDY00002259

UH3AT012413 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

480 participants in 2 patient groups

Tai Chi + Routine Care

Experimental group

Description:

The intervention will be delivered via a HIPAA-secure web-based video platform. All remote Tai Chi sessions will be 60 minutes, twice a week, for 3 months. All program components will use the Yang style Tai Chi, and every session will include warm up, review of principles, meditation with movement, breathing techniques and relaxation.

Treatment:

Other: Remote Tai Chi

Routine Care

No Intervention group

Description:

Participants will be encouraged to continue their ongoing care for Knee OA by their providers. In addition, primary care providers and other participating clinicians in the health system will receive information from the study team on routine care or "2019 ACR Guideline-Based Care." At the end of the 12-month trial period, routine care participants will be offered access to recordings for the full 3-month Tai Chi program (24 sessions).