Clinical Trial Finder

Remote Tai Chi for Knee Osteoarthritis

Study Purpose

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:

  • - Does remote Tai Chi improve the extent to which pain interferes with physical, mental, and social activities (PROMIS-Pain Interference at 3 months, primary outcome), as well as knee pain and function (WOMAC subscales) and analgesic use (secondary outcomes) - Does remote tai chi decreases healthcare utilization? 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.

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 50 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age 50 years or older.
  • - Treating clinician diagnosis of knee osteoarthritis.
  • - PROMIS Pain Interference Short Form 6b; score 4 or 5 on at least 1 of 6 questions (possible answers to each question range from 1 to 5) - Able to provide informed consent.
  • - If randomized to the Routine Care group, willing to abstain from Tai Chi programs until completion of the study.
  • - Has access to a home computer or device that will allow telehealth 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 reconstructive surgery.
  • - Beck Depression Inventory (BDI-II) suicide item (#9) score 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 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.

 NCT06384898
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.

 Tufts Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Chenchen Wang, MD, MScRobert Saper, MD, MPHEric Roseen, DC, PhDHelen Lavetrsky, MD, MS
Principal Investigator Affiliation Tufts Medical CenterThe Cleveland ClinicBoston Medical CenterUniversity of California, Los Angeles
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Knee Osteoarthritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Tai Chi + Routine Care

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.

No Intervention: Routine Care

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).

Interventions

Other: - Remote Tai Chi

Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements.

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.

Tufts Medical Center, Boston, Massachusetts

Status

Address

Tufts Medical Center

Boston, Massachusetts, 02111

Site Contact

Sherwood Alexis, MHA, MBA

[email protected]

617-636-5405

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